Medimetriks Announces that Otsuka Achieved Positive Top-Line Phase 3 Results for MM36 (difamilast) in Japanese Adult and Pediatric Atopic Dermatitis Patients

FAIRFIELD, N.J., March 26, 2020 /PRNewswire/ -- Medimetriks Pharmaceuticals, Inc., Inc. today announced that its partner, Otsuka Pharmaceuticals UK Ltd, achieved positive results in two Phase 3 Japanese clinical trials in adult and pediatric patients for MM36 (difamilast), a novel topical, non-steroidal phosphodiesterase IV (PDE4) inhibitor for the treatment of mild to moderate atopic dermatitis.

Please find below the Ostuka Pharmaceuticals press release:

"Otsuka Pharmaceutical Co., Ltd. (Otsuka) is pleased to announce top-line results from two phase 3 trials conducted in Japan for difamilast (OPA-15406) in patients with atopic dermatitis. One study was in adult patients and the other was in pediatric patients.

Difamilast is a novel atopic dermatitis drug candidate discovered by Otsuka that has phosphodiesterase 4 (PDE4) inhibitory activity. PDE4 inhibitors are believed to improve the symptoms of atopic dermatitis through suppression of the production of chemical mediators such as pro-inflammatory cytokines and through other anti-inflammatory effects. 

The two trials were conducted as multicenter, randomized, double-blind, vehicle-controlled (i.e., comparator), parallel-group studies. In the adult study, 1% difamilast ointment or the vehicle was applied twice daily for four weeks. In the pediatric study, 0.3% or 1% difamilast ointment or the vehicle was applied twice daily for four weeks.

Therapeutic effects were assessed using the Investigator's Global Assessment (IGA), a standard methodology in atopic dermatitis clinical trials that uses severity scoring to evaluate systemic symptoms.

In both the adult and pediatric trials, the IGA success rates, the primary endpoints as defined as the proportion of subjects whose IGA score was 0 (clear) or 1 (almost clear) and with improvement by at least 2 grades, were higher in the active-drug-treatment groups than in the vehicle groups, and the differences were statistically significant. No major adverse reactions were identified.

Trial outcomes will be analyzed further and findings will be announced at a scientific conference.

Otsuka entered into a licensing agreement with Medimetriks, Inc. in 2016 which granted Medimetriks development, marketing, and manufacturing rights for difamilast in the United States."

"We are excited about the results announced today by Otsuka and believe these results further validate the potential for MM36 (difamilast) as a best in class treatment for patients suffering from mild to moderate atopic dermatitis," said Bradley Glassman, Chairman and Chief Executive Officer of Medimetriks.  "We are preparing for our US Phase 3 MM36 (difamilast) trials and are committed to our goal of helping improve the lives of atopic dermatitis patients in the United States."    

About MM36 (difamilast)
Medimetriks has sole, exclusive US rights to develop and commercialize MM36. Discovered by Otsuka, MM36 is an investigational non-steroidal topical anti-inflammatory PDE-4 inhibitor in development for the potential treatment of atopic dermatitis. MM36 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 exhibits highly selective inhibitory activity against PDE4 subtype B, which is an enzyme that may play a significant role in inflammation, as well as its proprietary calibration between subtype B and subtype D.

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.

About Otsuka
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.  

About Medimetriks           
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

Media Contact:
David Addis          
Senior Vice President, Brand Communication         
Medimetriks Pharmaceuticals, Inc.
daddis@medimetriks.com  
+1 973 882 7512, extension 569

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SOURCE Medimetriks Pharmaceuticals, Inc.