- Only a single U.S. Pivotal Phase 3 Trial planned with significantly decreased number of patients
- Previously reported positive Phase 3 data from two difamilast trials conducted in Japan will be used to support U.S. NDA submission
- MM36 (difamilast) is a novel, nonsteroidal, highly selective PDE4 inhibitor being developed as a topical treatment for atopic dermatitis
FAIRFIELD, N.J., Sept. 18, 2020 /PRNewswire/ -- Medimetriks Pharmaceuticals, Inc. today announced that the Company received a Type C Meeting Written Response from the U.S. Food and Drug Administration (FDA) regarding MM36 (difamilast) for the topical treatment of mild to moderate atopic dermatitis (AD). Based upon the FDA response, Medimetriks is 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.
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%, 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," said Brad Glassman, Chairman and CEO of Medimetriks. "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."
About MM36 (difamilast)
Medimetriks has sole, exclusive US rights to develop and commercialize MM36 (difamilast). 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.
About Atopic Dermatitis
Atopic dermatitis (AD) is a chronic inflammatory skin condition characterized by red, swollen and cracked skin with intense itching. The onset of AD occurs most commonly between 3 and 6 months of age, with approximately 60% of patients developing the condition in the first year of life and 90% by 5 years of age. The majority of affected individuals have resolution of disease during childhood, although 10% to 30% of patients maintain the condition throughout their lives. A small percentage of the population develops first symptoms as adults. It has been estimated that approximately 18 million people are living with AD in the U.S. and this disease accounts for up to 20% of patient visits to dermatology offices.
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: "Otsuka – people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.
Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en.
Medimetriks Pharmaceuticals, Inc. is a leading independent branded Dermatology company focused on the development, licensing and commercialization of innovative prescription skincare brands. The Company is dedicated to addressing unmet physician and patient needs with unique therapies that advance patient care.
For more information, please visit: www.medimetriks.com
Medimetriks Media Contact:
Chief Operating Officer
Medimetriks Pharmaceuticals, Inc.
+1 973 882 7512, extension 569
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SOURCE Medimetriks Pharmaceuticals, Inc.