Positive trial data for olamkicept in inflammatory bowel diseases

Recently, members of the German Cluster of Excellence "Precision Medicine in Chronic Inflammation", in collaboration with CONARIS, had demonstrated the mechanism of action of olamkicept in humans and published initial efficacy data in 16 patients with the chronic inflammatory bowel diseases Crohn’s disease or ulcerative colitis [1].

In Crohn’s disease and ulcerative colitis, various immune system dysregulations cause recurrent disease flares with diarrhea, abdominal pain, and significant psychological distress. In Germany, more than 300,000 people suffer from these diseases. The few approved drugs only help a fraction of patients and often lose their effect over time. New therapeutic options are therefore urgently needed. The fusion protein olamkicept is the only active substance that selectively inhibits the trans-signaling pathway of the key immune messenger interleukin-6, which is important in chronic inflammation, but leaves other important functions of interleukin-6 – e.g. in the defense against infection or in metabolism – intact. Due to its unique mode of action, olamkicept is expected to have fewer side effects than conventional agents targeting interleukin-6 or other components of the immune system.

Olamkicept has been out-licensed by CONARIS to the Swiss pharmaceutical company Ferring Pharmaceuticals, which has been driving the development of olamkicept in Asia in recent years through its Chinese sublicensee I-Mab Biopharma. Results from a Phase II clinical trial in patients with moderate or severe ulcerative colitis have now been presented at the world’s leading gastroenterology conference, Digestive Disease Week (May 22-25, 2021) [2].

In this study, a total of 91 patients received either placebo or 300 mg or 600 mg of olamkicept per day for 12 weeks. The study was double-blinded, i.e. neither patients nor medical staff knew the group allocation. Clinical improvement was significantly more frequent in the 600 mg olamkicept group, with symptoms disappearing completely in around 21% of patients (compared with 0% in the placebo group). Healing of the intestinal mucosa was observed in almost 35% of patients (compared with 3% with placebo). As expected, olamkicept was significantly better tolerated by patients than conventional inhibitors blocking interleukin-6.

Following these encouraging data, the development partnership shall be expanded to develop olamkicept further in Phase III clinical trials.

[1] https://doi.org/…
[2] https://ddw.org/: DDW 2021 Late-Breaking Clinical Abstracts, Presentation Number 775b: B. Chen et al.: Olamkicept, an IL-6 trans-signaling inhibitor, is effective for induction of response and remission in a randomized, placebo-controlled trial in moderate to severe ulcerative colitis.

Website of CONARIS Research Institute AG: https://www.conaris.de/