MorphoSys AG announced today that its licensee Janssen Research & Development, LLC (Janssen), has further expanded the clinical development of guselkumab (Tremfya(R)) into ulcerative colitis (UC).
Janssen has initiated a proof-of-concept phase 2a clinical trial in patients with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease. This randomized, double-blind study will evaluate the efficacy and safety of guselkumab in combination with golimumab compared to guselkumab or golimumab monotherapy in approximately 210 patients with moderately to severely active UC.
Guselkumab is a human anti-IL-23 monoclonal antibody developed by Janssen that was generated utilizing MorphoSys’s proprietary HuCAL antibody technology.
Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys AG, said: “We are very pleased that our licensee Janssen has further expanded the clinical development program of guselkumab by initiating a clinical study in ulcerative colitis. We see a high medical need to investigate new treatment options for patients suffering from this inflammatory disease of the gastrointestinal tract.”
Guselkumab (tradename Tremfya(R)) has been approved in the U.S., Canada, the European Union, and several other countries for the treatment of plaque psoriasis and in Japan for the treatment of various forms of psoriasis, psoriatic arthritis, and palmoplantar pustulosis. Guselkumab is currently being investigated in clinical studies in several indications, including plaque psoriasis, pediatric psoriasis, psoriatic arthritis, Crohn’s disease, hidradenitis suppurativa, and now ulcerative colitis. MorphoSys is eligible to certain milestone payments and receives royalties on net sales of Tremfya(R).