PLANEGG, Germany & HORSHAM, Pa.—MorphoSys AG announced in April that its licensee, Janssen Research & Development, has further expanded the clinical development of guselkumab (Tremfya) into familial adenomatous polyposis (FAP), a disease of the gastrointestinal tract. Guselkumab is a human anti-IL-23 monoclonal antibody developed by Janssen that was generated utilizing MorphoSys’ proprietary HuCAL antibody technology.
Janssen has initiated a Phase 1b proof-of-concept clinical trial of guselkumab in patients with FAP, an autosomal dominantly inherited disorder characterized by the early onset of polyps throughout the colon. This randomized study will evaluate the efficacy and safety of guselkumab vs. placebo in approximately 72 patients with FAP.
“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,” said Dr. Markus Enzelberger, chief scientific officer of MorphoSys AG. “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.”
In connection with the start of clinical development in FAP, MorphoSys has received a milestone payment from Janssen. Financial details were not disclosed. MorphoSys is eligible for certain milestone payments regarding guselkumab, and receives royalties on net sales.
Guselkumab has been approved in the United States, Canada, the European Union and several other countries for the treatment of plaque psoriasis. In Japan it has been approved 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.
In February, Janssen announced that the U.S. Food and Drug Administration had approved Tremfya One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis. It is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4, and is intended for use under the guidance and supervision of a physician. Patients may self-inject after physician approval and proper training. Tremfya One-Press is now available in the U.S.
In the Phase 3, multicenter, randomized ORION study, patient experience with One-Press was assessed through a validated Self-Injection Assessment Questionnaire (SIAQ), which evaluated patient experience at weeks 0, 4 and 12 on a scale of 0 (worst) to 10 (best) across six domains (feelings about injections, self-image, self-confidence, pain and skin reactions during or after the injection, ease of use of the self-injection device and satisfaction with self-injection). The mean score for “Satisfaction with Self Injection” was 9.18 (with 10 indicating Very Satisfied), and the mean score for Ease of Use was 9.24 (with 10 indicating Very Easy).
The efficacy and safety of guselkumab administered with One-Press in patients with moderate-to-severe plaque psoriasis was also evaluated in the double-blind, placebo-controlled ORION study. A greater proportion of patients in the Tremfya group achieved an IGA score of 0 or 1 or a PASI 90 response at week 16 (81 percent and 76 percent, respectively) than in the placebo group (0 percent for both endpoints).
The proportion of patients who achieved an IGA score of 0 at week 16 was higher in the guselkumab group compared to the placebo group (56 percent vs. 0 percent). The proportion of patients who achieved a PASI 100 response at week 16 was also higher in the guselkumab group, compared to placebo (50 percent vs. 0 percent). The majority of injection-site reaction symptoms with One-Press were mild and transient in nature.
“The results of the ORION study showed the administration of Tremfya with One-Press was safe and effective, providing patients with a new, more convenient way to inject their treatment,” Dr. Laura Ferris, an associate professor in the Department of Dermatology of the University of Pittsburgh Medical Center, said in a news release. “These findings are also exciting as they demonstrated that treatment with Tremfya helped half the patients achieve complete clearance with a PASI 100 response at week 16.”