Medimetriks Pharmaceuticals, Inc. is moving forward with its MM36 (difamilast) Atopic Dermatitis Development Program following a meeting with the U.S. Food and Drug Administration (FDA).
Medimetriks is now preparing to conduct a single pivotal trial in the U.S. for MM36's New Drug Application (NDA), which will be supported by data from already-completed Phase 3 trials conducted in Japan. MM36 (difamilast) is a novel, nonsteroidal, highly selective PDE4 inhibitor being developed as a topical treatment for atopic dermatitis (AD)
Earlier this year Medimetriks announced that Otsuka Pharmaceutical Co., Ltd. achieved positive results in two Phase 3 clinical trials of MM36 (difamilast) conducted in Japan in adult and pediatric patients with AD.
Based upon FDA's recent guidance and the Company's successful End of Phase 2 Meeting, Medimetriks will also reduce the size of its MM36 (difamilast) Phase 3 pivotal trial program by approximately 80 percent, from the prior total of 1,578 patients across two pivotal trials to a projected total of 336 patients in a single pivotal U.S. trial.
"We are very pleased with the FDA meeting outcome, which paves the way to accelerate and complete the final steps of the MM36 development program," says Brad Glassman, Chairman and CEO of Medimetriks, in a news release. "Given MM36's potential class-leading efficacy, tolerability and itch relief demonstrated in Phase 2 and Phase 3 studies, we expect MM36 to be a formidable competitor to Pfizer's Eucrisa and AD development candidates from Arcutis and Incyte. Our goal remains steadfast and clear: to significantly enhance patient care and help children and adults suffering from AD achieve better outcomes. We plan to move forward aggressively and begin the final pivotal trial."
More on MM36
Discovered by Otsuka, MM36 (difamilast) is an investigational non-steroidal topical anti-inflammatory PDE4 inhibitor in development for the treatment of mild to moderate atopic dermatitis. MM36 (difamilast) is believed to exert anti-inflammatory action by inhibiting the production of cytokines and chemical mediators thought to cause the signs and symptoms of atopic dermatitis. In particular, MM36 (difamilast) exhibits highly selective inhibitory activity against PDE4 subtype B, which is an enzyme that may play a significant role in inflammation.