PR Newswire

CAMBRIDGE, Mass., Sept. 19, 2022

• Groundbreaking ALS biomarker research: Marks the first publication of NeuroSense's novel biomarker results demonstrating PrimeC's effect on ALS related hallmarks
• PrimeC showed a statistically significant impact on key disease-related biomarkers including TDP-43, which increases with disease progression, and LC3, a key autophagy marker  
• Based on successful Phase IIa results, NeuroSense commenced PARADIGM, a Phase IIb clinical trial in May 2022

CAMBRIDGE, Mass., Sept. 19, 2022 /PRNewswire/ --  NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced the peer-reviewed publication of Phase IIa clinical data in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration in a paper titled, "Combination of ciprofloxacin/celecoxib as a novel therapeutic strategy for ALS" authored by NeuroSense's Head of Scientific Program, Dr. Shiran Zimri, and Head of ALS Program, Avital Pushett, along with leading amyotrophic lateral sclerosis (ALS) researchers. View the paper in full here: LINK

Data in the paper are results from NeuroSense's Phase IIa study of its lead drug candidate, PrimeC, a unique and proprietary combination of two FDA-approved drugs—ciprofloxacin and celecoxib—in the treatment of ALS.

Key data from the paper include:

Safety:

• The study met its primary endpoint of safety in a 12-month clinical trial with 15 participants living with ALS.

Efficacy and Biomarkers:

• Exploratory efficacy was evaluated by ALSFRS-R and FVC, and blood samples were taken before and during the study for biomarker analysis.  
• PrimeC showed statistically significant changes in ALS-related biomarkers of serum neuron-derived exosomes (NDEs) such as TDP-43 and LC3 as measured by ExoSORT™ indicating a positive biological activity.   
• The trial was open-label, comparing the data generated to the PROACT database utilizing propensity matching.

Conclusions:

• This study supports the safety and tolerability of PrimeC in ALS.
• Biomarker analyses suggest early evidence of a biological effect.

"This clinical study is a very important achievement and milestone for the ALS community. It is very encouraging to see that there was both biological activity and clinical signals of a treatment effect," said Vivian Drory, MD, Director of the Neuromuscular Diseases Unit at Tel Aviv Sourasky Medical Center and Principal Investigator of the study. "I am thankful to all participants, their families, and staff who took part in this study, and proud and excited to participate in the PARADIGM study, which utilizes an upgraded formulation of PrimeC."

Based on the results of this study, NeuroSense commenced PARADIGM, a Phase IIb clinical trial in May 2022. PARADIGM is randomizing 69 people living with ALS at a 2:1 ratio to receive PrimeC or placebo, respectively. Primary endpoints of the study include assessment of ALS biomarkers, evaluation of clinical efficacy, improvement in quality of life, as well as safety and tolerability.

"This study, as well as previously published preclinical work, provides strong encouragement for the continued development of Prime C. We need more treatments for ALS, and PrimeC is an exciting candidate," stated Jeremy M. Shefner, MD, PhD, FAAN, Professor of Neurology, Chief Medical Officer for Clinical Research, at Barrow Neurological Institute, and co-author of the paper.

Dr. Erez Eitan, co-author of the study and Chief Scientific Officer of NeuroDex, stated, "We are proud to work with NeuroSense's team on the implementation of ExoSORT™, our proprietary method for isolating neuron-derived exosomes from blood samples for identification and measurement of biomarkers.  When we discovered that TDP43, a major ALS biomarker, and LC3, an autophagy biomarker, can be measured in NDEs and are different in ALS patients, we hoped this would help to advance therapeutic development. We are thankful to NeuroSense for providing us with the opportunity to test the biomarkers in their clinical trials." NeuroDex is advancing brain diagnostics through its proprietary cell-specific exosome diagnostic platform providing a noninvasive, inexpensive, and robust diagnostic tool.

"We thank the trial participants along with their families and caregivers for choosing to participate in this study. We would also like to thank all of our invaluable collaborators for their teamwork and relentless effort in the field and in this study," stated NeuroSense's Head of Scientific Program, Dr. Shiran Zimri.

"We are very pleased to have our Phase IIa findings of PrimeC published in a leading ALS journal, as interest in PrimeC continues to grow in the ALS scientific community. Our clinical research and scientific teams are actively presenting at conferences as we engage with patient advocacy groups with the aim of bringing a much needed effective treatment to people suffering from this debilitating disease," stated NeuroSense CEO Alon Ben-Noon.

About PrimeC

PrimeC, NeuroSense's lead drug candidate is a combination therapy that was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). NeuroSense completed a Phase IIa clinical study which successfully met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC's upgraded formulation, which is a unique extended-release tablet, developed to maximize the synergism between the compounds, is now being evaluated in a Phase IIb clinical trial, PARADIGM, for the treatment of ALS. Primary endpoints of the study include assessment of ALS biomarkers, evaluation of clinical efficacy, improvement in quality of life, as well as safety and tolerability. Through a collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes (NDEs), NeuroSense is working to further determine the biological changes in ALS-related pathologies and the effect of PrimeC on relevant targets.

About ALS

Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 patients are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected to grow 24% by 2040 in the U.S. and EU.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn and Twitter.

Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding patent applications; the company's PrimeC development program; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the timing of current and future clinical trials; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense Therapeutics Ltd. undertakes no duty to update such information except as required under applicable law.

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SOURCE NeuroSense Therapeutics

DEKALB COUNTY, Ga — DeKalb County’s internal auditors are refusing to release an obviously critical report of the county’s Oracle software system, which is used to manage everything from human resources to purchasing to payroll for a government that spends about $1.2 billion a year.

It’s clear from reading the public portions of the September 2022 report that the system is deeply flawed, but the auditors refuse to release details because they contend that might leave the already badly managed system open to sabotage or terrorism. Taxpayers are in the dark.

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“This is shameful as far as I’m concerned,” said Dr. Andy Green in an interview with Channel 2 investigative reporter Richard Belcher. Green teaches IT security at Kennesaw State University and has consulted with the channel on IT security issues for the better part of a decade.  He says “the real story” is “the fact that the county is using state law to be less than transparent with their citizens and not allow their citizens to engage in true oversight.”

Auditors look for flaws, document them and recommend changes to encourage improvements in government services or operations. They documented so-called “findings” in 10 separate areas of DeKalb’s Oracle system. One page that is not blacked out shows that six are coded red -— meaning more serious — and four are coded yellow. Those are also problems but not as serious as the ones coded red, but if you go looking for details, you’ll find page after page is blacked out or redacted.

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Green says the problems might be less serious than taxpayers worry, or, he says, “It could be that these things are actually much worse. The problem is we’re in the dark. The public is in the dark here.”

We emailed the spokesperson for DeKalb County, Michael Thurmond, and heard back from the county attorney’s office, which told us the redactions were the responsibility of the county’s internal auditors who are, by law, independent of the CEO and Board of Commissioners.

Lavois Campbell, the interim chief audit executive, emailed after our inquiry: “We have reviewed those determinations and judgments with legal counsel and our chairperson. The redacted sections relate to specific vulnerabilities in the Oracle application ‘which if made public could compromise security against sabotage, criminal or terroristic acts.’ O.C.G.A. § 50-18-72 (a)(25)(A). Those areas of vulnerability, if identified, would compromise the security of specific operations. We are constrained to do whatever is required to protect those operations from sabotage.”

Green mocked the county’s claim. “The idea that threat actors go around and collect these vulnerability assessment reports from these governmental entities to look for a way into the system is laughable on its face,” he told Channel 2.

He contends auditors could have found a way to release at least some of their findings. “They are not prohibited from releasing this. They are simply given an exception that says, ‘You don’t have to.’ The state law doesn’t say you are prohibited from (releasing the information), and to me, that’s a big difference,” he said.

A year ago, DeKalb’s independent auditors blacked out virtually everything in a report about the security of the private information of county employees and county vendors. We were stumped until Atlanta Journal Constitution report Tyler Estep obtained a copy of the full audit and shared it with us. The documented problems were serious and potentially embarrassing.

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Alzamend pursuing additional indications of bipolar disorder, major depressive disorder and post-traumatic stress disorder for AL001

ATLANTA--(BUSINESS WIRE)--$ACAD #AL001_mitigates_lithium_toxicities--Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder, major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced it has dosed its first healthy adult subject in its Phase IIA multiple ascending dose (“MAD”) study of AL001 in subjects with dementia related to Alzheimer’s. This blinded, placebo-controlled trial (AL001-02) was initiated in May 2022 and is designed to evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions and determine the maximum tolerated dose.

Alzamend is also pursuing AL001 for the treatment of bipolar disorder, MDD and PTSD. Based upon a recommendation by the U.S. Food and Drug Administration (“FDA”) after its review and commentary on Alzamend’s pre-investigational new drug (“IND”) briefing package for development of AL001 for bipolar disorder, MDD and PTSD, the ongoing clinical trial in Alzheimer’s patients has been expanded. As the safety and tolerability of AL001 would need to be tested in healthy and elderly adults before Alzamend could initiate later-stage testing of AL001 for bipolar disorder, MDD and PTSD, the addition of healthy and elderly adults to the on-going AL001-02 clinical trial would expedite the timing of further clinical trials. Alzamend will test AL001 in four healthy adult and elderly adult cohorts of eight subjects under MAD conditions.

AL001, a novel lithium-salicylate-L-proline engineered ionic cocrystal lithium delivery system, is under development as an oral treatment for patients with Alzheimer’s disease, and more recently for other neurodegenerative and neuropsychiatric disorders. AL001 has the potential to deliver benefits of marketed lithium carbonate while mitigating or avoiding current toxicities associated with lithium. In a Phase I relative bioavailability comparison of AL001 to lithium carbonate completed in March 2022, AL001 was shown to be bioequivalent at 50% less the dosage of lithium carbonate and the shapes of the lithium plasma concentration versus time curves were similar. Additionally, AL001 salicylate plasma concentrations were observed to be well tolerated and consistently within safe limits and the safety profiles of both AL001 and the marketed lithium carbonate capsule were benign.

“Adding healthy adult and elderly subjects to the Phase IIA MAD clinical trial is in response to latest FDA guidance regarding our forthcoming INDs for AL001 as a treatment of bipolar disorder, MDD and PTSD,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We are one step closer to providing patients, caregivers and clinicians with a major improvement over current lithium-based treatments that can help over 40 million Americans suffering from Alzheimer’s, bipolar disorder, MDD and PTSD. We look forward to completing the AL001-02 study and further advancing clinical development of this promising potential therapeutic.”

About Alzamend Neuro

Alzamend is an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, bipolar disorder, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 - a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, salicylate, and L-proline, and ALZN002 - a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. real results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend’s business and financial results are included in Alzamend’s filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend’s website at www.Alzamend.com.

Email: Info@Alzamend.com or call: 1-844-722-6333

NMD Pharma Reports Positive Top-Line Data from a Phase I/IIa Clinical Trial of NMD670in Patients with Myasthenia Gravis

• Data provides first clinical proof of themechanismof action of NMD Pharma's ClC-1 chloride ion channelinhibitorin patients suffering from myasthenia gravis
• NMD670 was safe and well tolerated, withclinically significant improvements in the Quantitative Myasthenia Gravis Scorein patients andchanges in electrophysiological endpoints that demonstrated target engagement and restoration of neuromuscular transmission
• The clinical validation of ClC-1 inhibition to restore neuromuscular function leading to clinical meaningful effects even with a single dose in patients with myasthenia gravis provides a unique translational platform for NMD Pharma and informs new clinical studies in additional indications characterized by neuromuscular dysfunction

Aarhus, Denmark, 11October 2022 - NMD Pharma A/S, a clinical stage biotech company developing first-in-class, small molecule ClC-1 inhibitors for neuromuscular disorders, today reported positive top-line results from a Phase I/IIa clinical trial of NMD670, recently granted orphan drug designation by the FDA for treatment of myasthenia gravis (MG).

The Phase I part included single ascending dose and multiple ascending dose in 67 healthy volunteers. The Phase IIa part was a single dose, proof of mechanism, randomized, placebo-controlled, double-blind, three-way cross-over study, investigating the safety and pharmacodynamic effects of NMD670 at two dose levels in 12 patients with MG.

NMD670 was safe and well tolerated in healthy volunteers and patients. Administration of single doses of NMD670 was associated with clinically significant improvements in the Quantitative Myasthenia Gravis Score with up to 50% of the patients meeting pre-specified responder criterion. Electrophysiological endpoints demonstrated target engagement and restoration of neuromuscular transmission that in patients were associated with increases in muscle strength and function.

The trial took place at the Centre for Human Drug Research.

Dr. Geert Jan Groeneveld, Chief Scientific Officer and Chief Medical Officer at the Centre for Human Drug Research (CHDR) and the Principal Investigator of the trial said: "I would like to thank the study participants, their families and caregivers for participating in the NMD670 clinical study. These positive clinical data provide valuable early insights into the potential of ClC-1 inhibition to enhance neuromuscular transmission for myasthenia gravis and other neuromuscular diseases."

Thomas Holm Pedersen, Chief Executive Officer of NMD Pharma, said: "These trial results represent an important milestone for NMD Pharma as they provide the first clinical proof of mechanism for our novel ClC-1 inhibitor treatment approach. With these data we complete an important journey from conceptualizing a new treatment concept to obtaining clinical proof of mechanism, and further establish the relevance of pursuing the development of ClC-1 inhibitors across a range of diseases associated with neuromuscular dysfunction. I would like to thank the NMD Pharma team for their many contributions to making this trial a success and, most importantly, the patients who participated in the study."

NMD Pharma will publish the full trial data in a peer reviewed journal and present the findings at a leading industry conference over the coming months.

-END-

Contacts

NMD Pharma A/S
Thomas Holm Pedersen, CEO
E-mail: contact@nmdpharma.com

Consilium Strategic Communications
Mary-Jane Elliott / Ashley Tapp / Lindsey Neville
E-mail: NMDPharma@consilium-comms.com
Tel: +44 (0)20 3709 5700

About NMD Pharma
NMD Pharma A/S, is a private biotech company leading in the development of novel first-in-class therapies for severe neuromuscular disorders. The Company was incorporated as a spin-off from Aarhus University, Denmark in 2015 and was founded on more than 15 years of muscle physiology research with a focus on regulation of skeletal muscle excitability under physical activity. NMD Pharma has built a world-leading muscle electrophysiology platform leveraging the in-depth know-how of muscle physiology and muscular disorders, small molecule modulators, enabling technologies and tools as well as in vivo pharmacology models for discovering and developing proprietary modulators of neuromuscular function. NMD Pharma received initial seed financing in 2016 and have since raised ~€80 million from investors including Novo Holdings, Lundbeckfonden BioCapital, INKEF Capital, Roche Venture Fund, and Jeito Capital. Find out more about us online at http://www.nmdpharma.com/.

About NMD670
NMD670 is NMD Pharma's lead development program. It is a first-in-class small molecule inhibitor of the skeletal muscle specific chloride ion channel (ClC-1). NMD Pharma has demonstrated that ClC-1 inhibition enhances neuromuscular transmission and restores skeletal muscle function, and this novel treatment approach has demonstrated compelling preclinical efficacy data in animal models of myasthenia gravis (MG) and a range of other neuromuscular disorders. NMD670 has recently been granted orphan-drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for treatment of MG.

About Myasthenia Gravis (MG)
MG is a rare and chronic autoimmune disease where IgG antibodies disrupt communication between nerves and muscles causing debilitating and potentially life-threatening muscle weakness. It commonly affects the muscles that control the eyes and eyelids, facial expressions, chewing, swallowing, and speaking but in most patients it eventually impacts most skeletal muscles. More than 85% of people with MG progress to generalized MG (gMG) within 18 months and it can be life-threatening when affecting the muscles responsible for breathing. There are approximately 100,000 people in the European Union, 65,000 people in the United States and 20,000 people in Japan living with the disease.

About the Centre for Human Drug Research
The Centre for Human Drug Research.

RAWALPINDI: Rubbish at concourse hall of Islamabad International Airport (IIA) led to the transfer of three senior officials.

Prime Minister Shehbaz Sharif and Aviation Minister Khawaja Saad Rafique had noticed a video on social media showing waste dumped in the airport’s concourse hall and ordered an inquiry.

A notification was issued by the Civil Aviation Authority’s (CAA) human resource directorate, which said Airport Manager (APM) Mohammad Adnan Khan had been transferred and posted as chief operating officer (COO) till further order, while Haq Nawaz, joint director communication who was serving as duty terminal manager, was transferred to Allama Iqbal International Airport.

Habib Khan, superintendent airport security, was transferred to Bacha Khan International Airport Peshawar, while additional charge of deputy APM was from withdrawn from Iqtidar Haider.

The notification said all those transferred were to be relieved with immediate effect and were to join their new assignment.

Published in Dawn, October 8th, 2022

• Groundbreaking ALS biomarker research: Marks the first publication of NeuroSense's novel biomarker results demonstrating PrimeC's effect on ALS related hallmarks
• PrimeC showed a statistically significant impact on key disease-related biomarkers including TDP-43, which increases with disease progression, and LC3, a key autophagy marker  
• Based on successful Phase IIa results, NeuroSense commenced PARADIGM, a Phase IIb clinical trial in May 2022

CAMBRIDGE, Mass., Sept. 19, 2022 /PRNewswire/ --  NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced the peer-reviewed publication of Phase IIa clinical data in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration in a paper titled, "Combination of ciprofloxacin/celecoxib as a novel therapeutic strategy for ALS" authored by NeuroSense's Head of Scientific Program, Dr. Shiran Zimri, and Head of ALS Program, Avital Pushett, along with leading amyotrophic lateral sclerosis (ALS) researchers. View the paper in full here: LINK

Data in the paper are results from NeuroSense's Phase IIa study of its lead drug candidate, PrimeC, a unique and proprietary combination of two FDA-approved drugs—ciprofloxacin and celecoxib—in the treatment of ALS.

Key data from the paper include:

Safety:

• The study met its primary endpoint of safety in a 12-month clinical trial with 15 participants living with ALS.

Efficacy and Biomarkers:

• Exploratory efficacy was evaluated by ALSFRS-R and FVC, and blood samples were taken before and during the study for biomarker analysis.  
• PrimeC showed statistically significant changes in ALS-related biomarkers of serum neuron-derived exosomes (NDEs) such as TDP-43 and LC3 as measured by ExoSORT™ indicating a positive biological activity.   
• The trial was open-label, comparing the data generated to the PROACT database utilizing propensity matching.

Conclusions:

• This study supports the safety and tolerability of PrimeC in ALS.
• Biomarker analyses suggest early evidence of a biological effect.

"This clinical study is a very important achievement and milestone for the ALS community. It is very encouraging to see that there was both biological activity and clinical signals of a treatment effect," said Vivian Drory, MD, Director of the Neuromuscular Diseases Unit at Tel Aviv Sourasky Medical Center and Principal Investigator of the study. "I am thankful to all participants, their families, and staff who took part in this study, and proud and excited to participate in the PARADIGM study, which utilizes an upgraded formulation of PrimeC."

Based on the results of this study, NeuroSense commenced PARADIGM, a Phase IIb clinical trial in May 2022. PARADIGM is randomizing 69 people living with ALS at a 2:1 ratio to receive PrimeC or placebo, respectively. Primary endpoints of the study include assessment of ALS biomarkers, evaluation of clinical efficacy, improvement in quality of life, as well as safety and tolerability.

"This study, as well as previously published preclinical work, provides strong encouragement for the continued development of Prime C. We need more treatments for ALS, and PrimeC is an exciting candidate," stated Jeremy M. Shefner, MD, PhD, FAAN, Professor of Neurology, Chief Medical Officer for Clinical Research, at Barrow Neurological Institute, and co-author of the paper.

Dr. Erez Eitan, co-author of the study and Chief Scientific Officer of NeuroDex, stated, "We are proud to work with NeuroSense's team on the implementation of ExoSORT™, our proprietary method for isolating neuron-derived exosomes from blood samples for identification and measurement of biomarkers.  When we discovered that TDP43, a major ALS biomarker, and LC3, an autophagy biomarker, can be measured in NDEs and are different in ALS patients, we hoped this would help to advance therapeutic development. We are thankful to NeuroSense for providing us with the opportunity to test the biomarkers in their clinical trials." NeuroDex is advancing brain diagnostics through its proprietary cell-specific exosome diagnostic platform providing a noninvasive, inexpensive, and robust diagnostic tool.

"We thank the trial participants along with their families and caregivers for choosing to participate in this study. We would also like to thank all of our invaluable collaborators for their teamwork and relentless effort in the field and in this study," stated NeuroSense's Head of Scientific Program, Dr. Shiran Zimri.

"We are very pleased to have our Phase IIa findings of PrimeC published in a leading ALS journal, as interest in PrimeC continues to grow in the ALS scientific community. Our clinical research and scientific teams are actively presenting at conferences as we engage with patient advocacy groups with the aim of bringing a much needed effective treatment to people suffering from this debilitating disease," stated NeuroSense CEO Alon Ben-Noon.

About PrimeC

PrimeC, NeuroSense's lead drug candidate is a combination therapy that was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). NeuroSense completed a Phase IIa clinical study which successfully met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC's upgraded formulation, which is a unique extended-release tablet, developed to maximize the synergism between the compounds, is now being evaluated in a Phase IIb clinical trial, PARADIGM, for the treatment of ALS. Primary endpoints of the study include assessment of ALS biomarkers, evaluation of clinical efficacy, improvement in quality of life, as well as safety and tolerability. Through a collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes (NDEs), NeuroSense is working to further determine the biological changes in ALS-related pathologies and the effect of PrimeC on relevant targets.

About ALS

Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 patients are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected to grow 24% by 2040 in the U.S. and EU.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn and Twitter.

Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding patent applications; the company's PrimeC development program; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the timing of current and future clinical trials; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense Therapeutics Ltd. undertakes no duty to update such information except as required under applicable law.

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SOURCE NeuroSense Therapeutics