I-Mab 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.
I-Mab is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area.
The Company’s mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab’s globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company’s unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies.
The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States.