Benzinga | Apr 26, 2021 09:58AM EDT

I-Mab's IL-6 Drug Hits Primary Endpoint Goal In Mid-Stage Ulcerative Colitis Study

* I-Mab (NASDAQ: IMAB) has announced topline results from its Phase 2 study evaluating olamkicept (also known as TJ301) in patients with active ulcerative colitis (UC).

* The study met its primary endpoint and provided early evidence that I-Mab's IL-6 inhibitor improves outcomes, including rectal bleeding.

* After 12 weeks of twice-monthly infusions, response rates were higher in the 600-mg olamkicept arm than placebo, resulting in a p-value of 0.032. Olamkicept at 600 mg outperformed placebo in terms of clinical remission and mucosal healing.

* For those secondary endpoints, I-Mab reported p-values of less than 0.001. I-Mab said the drug was "well-tolerated, and with a very acceptable safety profile."

* The company is yet to share details of the numbers of responders in each cohort or information on the 300-mg dose.

* Detailed data analysis will be presented at Digestive Disease Week 2021 in May and at European Crohn's and Colitis Organization meeting in July.

* I-Mab had secured the Asian rights to olamkicept from Ferring in 2016. Last week, I-Mab and Ferring signed a memorandum of understanding to "explore a possible collaboration to advance the development and commercialization of olamkicept" in the U.S., Canada, the European Union, and Japan."

* Olamkicept is a selective IL-6 inhibitor that works through the trans-signaling mechanism. IL-6 is a vital driver cytokine in the propagation and maintenance of chronic inflammation in autoimmune diseases.

* Price Action: IMAB shares are up 1.4% at $64.62 in market trading hours on the last check Monday.