OSE Immunotherapeutics Reports Positive Phase 2 Results for Anti-IL7R mAb Lusvertikimab in Ulcerative Colitis Treatment

NANTES, France I November 4, 2024 I OSE Immunotherapeutics SA has announced encouraging results from the induction phase of their CoTikiS Phase 2 clinical trial of Lusvertikimab (OSE-127). This randomized, double-blind, placebo-controlled study evaluated the drug's effectiveness and safety in treating moderate to severe active ulcerative colitis (UC).

The CoTikiS Phase 2 study involved 136 patients with moderate to severe active UC who did not respond to prior treatments. The trial spans 50 weeks, starting with a 10-week induction period where patients received either 450mg or 850mg doses of Lusvertikimab or a placebo. Following this, a 24-week open-label extension (OLE) period allowed all participants to receive 850mg doses of Lusvertikimab every four weeks. The trial concluded with a 16-week safety follow-up without treatment.

Lusvertikimab achieved the primary efficacy endpoint by improving the Modified Mayo Score (MMS) at week 10 (W10) for both tested doses. The results also indicated significant improvements in key secondary endpoints, including clinical remission, endoscopic remission, and endoscopic improvement. Moreover, the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scores showed a marked reduction at W10.

During the induction period and the subsequent 24-week OLE, Lusvertikimab displayed a favorable safety profile. No significant differences in serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, severe drug-related AEs, opportunistic infections, or infusion reactions were observed between the treatment groups and placebo. Additionally, patients who received the 850mg dose for the extended 24-week period exhibited no new safety concerns.

Pr. Arnaud Bourreille, Associate Professor in Gastroenterology at Nantes University Hospital and principal investigator of the CoTikiS study, expressed enthusiasm over the results. He highlighted Lusvertikimab's potential as a breakthrough treatment for UC, noting the impressive endoscopic efficacy and safety profile. Bourreille emphasized the need for further investigation in UC and other conditions, acknowledging the contributions of the study's investigators and participants.

Nicolas Poirier, CEO of OSE Immunotherapeutics, also commented on the trial outcomes, citing the significant milestone these results represent in Lusvertikimab’s clinical development. He underscored the drug's demonstrated clinical proof-of-efficacy in UC and its potential to address the unmet need for more effective and safe treatments. Poirier noted that Lusvertikimab is a pure interleukin-7 receptor antagonist monoclonal antibody (mAb), suggesting a broad first-in-class potential for treating various chronic inflammatory and autoimmune diseases. He expressed eagerness to advance this strategy in collaboration with relevant partners.

The study’s population included patients who had previously been treated with corticosteroids, immunosuppressive agents, or biological therapies. The primary endpoint was the mean change from baseline in the MMS at W10, a clinical index for UC that combines stool frequency, rectal bleeding, and endoscopic scores. An interim futility analysis initially suggested discontinuing the 450mg group due to risk, but the final analysis did not confirm this futility, allowing the results of all patients to be reconsidered and the groups pooled for a comprehensive assessment of treatment efficacy.

Overall, the CoTikiS Phase 2 study provides promising evidence supporting Lusvertikimab as a potential new therapy for UC, with significant implications for future research and clinical application in other chronic inflammatory conditions.