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A phase 3 trial of Lilly’s inflammatory diseases challenger mirikizumab in ulcerative colitis has met its target – potentially adding further competition to a crowded market.

Johnson & Johnson (Stelara) and AbbVie (Humira) are among the big players with powerful drugs approved to treat ulcerative colitis.

As well as other gastrointestinal disorders, Lilly is also targeting psoriasis with mirikizumab, an anti-IL-23p19 antibody.

Latest data from the LUCENT-1 trial show that it had met its primary endpoint of clinical remission and all key secondary endpoints compared with placebo.

The study also showed reduced bowel urgency in moderate to severe ulcerative colitis, the first phase 3 trial of a drug in this class to do so.

Patients completing LUCENT-1, a 12-week induction study, have been moved on to the ongoing LUCENT-2 study.

Clinical remission is met when inflammation of the colon is controlled or resolved, leading to normalisation or near-normalisation of symptoms such as stool frequency and bleeding.

Lilly has not published details but data show a highly significant improvement against this measure.

The company noted that mirikizumab also achieved all key secondary endpoints compared to placebo at week 12 in patients with UC with highly statistically significant p-values, including reduced bowel urgency, clinical response, endoscopic remission, symptomatic remission and improvement in endoscopic histologic inflammation.

It demonstrated rapid improvement in patient symptoms as early as four weeks after initiating treatment.

Mirikizumab also reduced symptoms among patients who had previously not responded to or stopped responding to biologic and/or Janus kinase (JAK) inhibitor therapies.

Lilly said there were no surprises in terms of safety, with adverse events in line with a previous phase 2 study.

The most common adverse events included nasopharyngitis, anaemia and headache for both placebo and mirikizumab-treated patients.

The full LUCENT study results, including data from LUCENT-2 and LUCENT-3, will be disclosed at a future congress or publication.

© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

U.S. FDA Grants an Investigational Device Exemption for Trial Evaluating Novel AlucentNVS Technology

SALT LAKE CITY, August 02, 2023--(BUSINESS WIRE)--Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration granted an Investigational Device Exemption (IDE) for a U.S. clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology.

AlucentNVS combines an intravascular device with a photochemical process to link structural proteins in the wall of a blood vessel to control vascular remodeling. The intervention is designed to promote patency of the vessel’s lumen and establish sustained improvement of blood flow. AlucentNVS is also designed to retain the natural functionality and flexibility of the vascular wall, while avoiding traditional complications of inserting permanent implants.

"IDE approval by the FDA’s Division of Coronary and Peripheral Interventional Devices is another validation of our novel approach to treating vascular disease," said Dr. Myles Greenberg, CEO of Alucent Biomedical. "AlucentNVS technology is poised to change the standard of care in treating patients undergoing life- and limb-saving vascular procedures."

AlucentNVS is currently being evaluated in two feasibility trials in Australia and Poland, also examining its use in treating peripheral artery disease (PAD) and promoting the maturation of arteriovenous fistulas (AVF) for patients requiring hemodialysis. Enrollment in those trials is expected to conclude by the end of 2023.

About Alucent Biomedical

Alucent Biomedical Inc. is a privately held company dedicated to developing and commercializing its breakthrough AlucentNVS technology for the treatment of vascular disease. AlucentNVS is designed to use photoactivated protein linking of the vessel’s native structural proteins to open vessels and keep them open. Alucent Biomedical was founded by the Avera Research Institute, part of the multistate Avera Health System, in 2017. For more information, please visit alucentbiomedical.com, or find us on LinkedIn.

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