▎WuXiEdited by the Kant Content Team

GSK's Ultra-Long-Acting Antibody Therapy Meets Primary Endpoints in Two Phase 3 Clinical Trials

GSK announced today that the investigational ultra-long-acting antibody therapy depemokimab met the primary endpoints in two Phase 3 clinical trials, ANCHOR-1 and ANCHOR-2, for the treatment of patients with chronic rhinosinusitis with nasal polyps (CRSwNP).Compared with placebo, depemokimab significantly improved patients' endoscopic nasal polyp scores at week 52; it also improved patients' average nasal congestion scores from weeks 49 to 52.Both groups of patients received standard background treatment.

The press release pointed out,Depemokimab is the first ultra-long-acting biologic therapy used in Phase 3 clinical trials to treat CRSwNP. It has an extended half-life, strongly binds to IL-5, and requires patients to be treated only once every six months.IL-5 is highly expressed in nasal polyp tissue and is one of the key cytokines mediating type 2 inflammation.

Specific data for ANCHOR-1 and ANCHOR-2 will be reported at future medical conferences. Previously, depemokimab showed results in a Phase 3 clinical trial for the treatment of severe asthma patients with Type 2 inflammation characteristics (marked by blood eosinophil count).SWIFT-1 and SWIFT-2Also reached the primary endpoint in China. The press release stated that the results of these four trials will be used to support regulatory submissions worldwide.

Lilly's Anti-IL-23 Antibody Shows Positive 1-Year Results in Crohn's Disease Treatment

Eli Lilly and Company announced positive results from the Phase 3 clinical trial VIVID-1 of the IL-23 antibody mirikizumab for the treatment of patients with moderate to severe Crohn's disease. After 52 weeks of treatment, a higher proportion of patients in the mirikizumab group achieved histological remission compared to the active control group.

VIVID-1 is a randomized, double-blind, Phase 3 clinical trial comparing the efficacy of mirikizumab versus placebo and the active comparator ustekinumab in patients with moderate to severe Crohn's disease.

The trial results showed that, compared with placebo, mirikizumab achieved statistically significant improvements in all histological and histological-endoscopic indicators. In addition,In the overall patient population, the proportion of patients achieving histological remission at week 52 was higher in the mirikizumab group compared to the active comparator group (58.2% vs. 48.8%; p=0.0075). Among patients with active histological disease at baseline and at least one prior failure of biologic therapy, mirikizumab also demonstrated higher rates of histological remission at week 52 (56.5% vs. 41.3%; p=0.0064) and endoscopic-histological remission (39.6% vs. 27.8%; p=0.024) compared to the active comparator.

▲To learn more about the application of cutting-edge technologies in the biopharmaceutical industry, please long-press and scan the QR code above to access "WuXi Live Studio" and watch live discussions and exciting replays on related topics.

References：