MorphoSys Announces Its Licensee Janssen Initiated a Phase 2 Study (NOVA) to Evaluate Guselkumab in Hidradenitis Suppurativa
MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) announced today that its licensee Janssen Research & Development, LLC (Janssen) initiated a phase 2 clinical study of guselkumab in patients with moderate to severe hidradenitis suppurativa (HS), a chronic skin disease also known as acne inversa. According to clinicaltrials.gov, the randomized, double-blind study, NOVA, is expected to enroll approximately 180 adult patients with moderate to severe HS and will evaluate the efficacy, safety and tolerability of guselkumab against placebo.
Guselkumab is a human anti-IL-23 monoclonal antibody developed by Janssen, and was generated utilizing MorphoSys’s proprietary HuCAL antibody technology.
Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys AG, said: “We are pleased to see that our licensee Janssen has started its first clinical study with guselkumab in hidradenitis suppurativa. We see a high medical need for new treatment options to help patients suffering from this very painful and debilitating skin disease.”
In addition to the clinical development in HS, guselkumab is currently being investigated in clinical studies including two phase 3 trials in psoriatic arthritis, a phase 3 study in pediatric psoriasis patients, a phase 3 trial evaluating the efficacy of guselkumab compared with secukinumab in the treatment of adults with moderate to severe plaque psoriasis as well as a phase 2/3 clinical study program in Crohn’s disease.
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 and of psoriatic arthritis. MorphoSys is eligible to receive certain milestone payments and receives royalties on sales of Tremfya(R).
More information about guselkumab clinical studies is available on clinicaltrials.gov.
About Hidradenitis Suppurativa (HS)
Hidradenitis suppurativa (HS), also known as acne inversa, is a debilitating, painful chronic inflammatory skin disease characterized by the occurrence of inflamed and swollen lumps (nodules) and fistulas. These are typically painful and break open releasing fluid or pus. The areas most commonly affected are the armpits, under the breasts, and groin. Scar tissue remains after healing. The recurrent nodules and abscesses cause chronic pain and can lead to self-consciousness, social isolation, and depression. Currently, there is no known cure. For reasons that are unclear, women are about twice as likely as men to develop the condition1. HS is a rarely diagnosed, but not a rare disease2. According to literature, global estimates of prevalence vary between 0.03% and 4% of the population3. According to a recent population-based analysis, the overall point prevalence of hidradenitis suppurativa was 0.10%, or 98 per 100 000 persons in the United States2.