A novel treatment for ulcerative colitis, Lusvertikimab, has shown promising efficacy in a recently concluded phase 2 clinical trial. The first-in-class interleukin 7 (IL-7) receptor antagonist was evaluated for its effectiveness in patients suffering from moderate to severe ulcerative colitis (UC). Conducted as a randomized, placebo-controlled study, the trial involved 136 adults who had not adequately responded to conventional therapies or had failed advanced treatments. The trial, funded by OSE Immunotherapeutics, heralds a new era in UC treatment with its unique targeting of the IL-7 receptor, a crucial element in immune-mediated inflammation.
The study incorporated a 10-week induction period during which patients received two different doses of lusvertikimab, 450 mg and 850 mg. The primary endpoint focused on the improvement in the modified Mayo score (MMS) from baseline to week 10. Results showed that lusvertikimab significantly reduced disease severity compared to placebo across both dosage groups individually and collectively.
"We have a new mode of action in ulcerative colitis," said Arnaud Bourreille, MD.
Remarkably, this trial demonstrated that lusvertikimab not only met but exceeded its primary endpoint. The results revealed an impressive reduction in disease indicators, with fecal calprotectin levels dropping by 830 μg/g in the 450-mg group, 635 μg/g in the 850-mg group, and 716 μg/g when both groups were pooled. Clinical remission and endoscopic remission, considered secondary endpoints, also showed favorable outcomes for the pooled doses compared to placebo.
"We achieved the primary endpoint" — improvement in the modified Mayo score (MMS) from baseline to week 10 — "for both the low dose and the high dose of lusvertikimab," stated Arnaud Bourreille, MD.
The trial further explored the long-term effects of lusvertikimab through a 24-week open-label extension, where patients received infusions of the high dose every four weeks. A subsequent 16-week safety follow-up period ensured rigorous monitoring without treatment. Notably, around 40% of participants had been exposed to one or more biologics, underscoring lusvertikimab's efficacy even among those with extensive prior treatments.
"For us practitioners, this is very good news," emphasized Arnaud Bourreille, MD.
Safety assessments revealed that lusvertikimab was well-tolerated among patients. Transient lymphopenia was observed; however, it did not lead to any infections or require treatment interruption.
"it was transient lymphopenia, without any infection and without any need to interrupt the treatment," explained Arnaud Bourreille, MD.
The encouraging results from this trial not only highlight the potential of lusvertikimab as a viable treatment for UC but also pave the way for further research and development. By specifically targeting the IL-7 receptor, lusvertikimab presents a novel mechanism of action that could transform the therapeutic landscape for patients struggling with UC.
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