I-Mab: Positive Topline Phase 2 Results for Olamkicept in Ulcerative Colitis

  I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced positive topline results from its regional multi-center, randomized, double-blind and placebo-controlled phase 2 study (NCT03235752) evaluating the efficacy and safety of olamkicept (also known as TJ301) administered intravenously biweekly in patients with active ulcerative colitis (UC).

Olamkicept is the only clinical stage selective IL-6 inhibitor that works through the trans-signaling mechanism. IL-6 is an important driver cytokine in the propagation and maintenance of chronic inflammation in autoimmune diseases, such as UC.

The phase 2 study, one of the first placebo-controlled, proof-of-concept studies of an IL-6 inhibitor in UC, has met both its primary and key secondary efficacy endpoints, demonstrating significantly higher clinical response rates after 12 weeks of treatment in patients receiving 600 mg olamkicept compared to those on placebo (p=0.032). Significantly more patients in the 600 mg olamkicept group achieved clinical remission and mucosal healing than in placebo (p<0.001), two key secondary endpoints of the study. Olamkicept was well tolerated, and with a very acceptable safety profile. Detailed data analysis will be presented at Digestive Disease Week (DDW) 2021 in the U.S. in May and at European Crohn's and Colitis Organisation (ECCO) meeting in July 2021.

https://www.biospace.com/article/releases/i-mab-announces-positive-topline-phase-2-results-for-olamkicept-in-ulcerative-colitis/