MorphoSys AG announced that its licensee Janssen Research & Development, LLC, has further expanded the clinical development of guselkumab (Tremfya(R)) into familial adenomatous polyposis (FAP), a disease of the gastrointestinal tract.
Janssen has initiated a phase 1b proof-of-concept clinical trial of guselkumab in patients with FAP, a dominantly inherited disorder characterized by the early onset of polyps throughout the colon which may develop into colon cancer, if not treated. This randomized study will evaluate the efficacy and safety of guselkumab vs. placebo in approximately 72 patients with FAP.
In connection with the start of clinicial development in FAP, MorphoSys received a milestone payment from Janssen. Financial details were not disclosed.
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 the clinical study in familial adenomatous polyposis. We see a high medical need to investigate new treatment options for patients suffering from this serious inflammatory disease of the gastrointestinal tract which, if not treated, may develop into colon cancer."
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 additional studies in plaque psoriasis, pediatric psoriasis, psoriatic arthritis, Crohn's disease, hidradenitis suppurativa, ulcerative colitis and now familial adenomatous polyposis. MorphoSys is eligible to certain milestone payments and receives royalties on net sales of Tremfya(R).