Benzinga | Apr 26, 2021 07:04AM EDT

I-Mab Reports Topline Phase 2 Results For Oalmkicept In Ulcerative Colitis: Met Both Primary, Key Secondary Endpoints

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-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.

"We are very excited to see that olamkicept demonstrated significant clinical benefits for active UC patients in terms of safety and efficacy through this successful phase 2 study. This is the first demonstration that IL-6 blockade through the trans-signaling pathway plays a significant therapeutic role in UC. The study provides confidence for further clinical development of this differentiated IL-6 blocker as a treatment option for UC and IBD," said Prof. Minhu Chen, Chair of Gastroenterology and Hepatology and Vice President at the First Affiliated Hospital of Sun Yat-sen University, principal investigator of the study.

I-Mab entered into a license agreement with Ferring Pharmaceuticals to develop and commercialize olamkicept for Greater China and South Korea in 2016. On April 23rd, 2021, the Company and Ferring signed a memorandum of understanding (MoU) to explore a possible collaboration to advance the development and commercialization of olamkicept in US and Canada, the European Union and Japan, if so agreed.

"There is an unmet need in the management of inflammatory bowel disease, such as UC, as current pharmacological therapies have significant side effects and develop resistance over time," said Dr. Joan Shen, CEO of I-Mab. "The positive phase 2 clinical data support our belief that olamkicept has the potential to become standard of care in UC, and we are excited by the prospect of exploring a broader reach to patients globally and offer a new treatment option."