FAIRFIELD, N.J., Sept. 6, 2017 /PRNewswire/ -- Medimetriks Pharmaceuticals, Inc. today announced positive results of its Phase 2, multi-center, open-label, maximal use systemic exposure (MUSE) study of MM36, a novel topical, non-steroidal phosphodiesterase-4 (PDE4) inhibitor in development for the treatment of atopic dermatitis (AD). The study showed that MM36 appears to be safe, well-tolerated and provides rapid itch relief when applied twice daily to pediatric and adolescent patients with AD.
The study consisted of 32 patients with predominantly moderate or severe AD (based on Investigator Global Assessment) and mean baseline total body surface area involvement of 43.7%. The study’s primary endpoint was assessment of pharmacokinetic absorption under maximal use conditions for four weeks, with secondary endpoints of safety and tolerability based on local and systemic adverse events. The study showed that overall blood concentration of MM36 was low and consistent with earlier studies. MM36 appears to be safe and well-tolerated with no serious adverse events observed during the study.
Exploratory efficacy endpoints included assessment of time to itch relief, change in sleep patterns and improvement in disease severity using several validated scales.
Early Itch Relief
Relieving chronic itch, or pruritus, is an integral part of treating AD. Pruritus causes scratching which can lead to significant epidermal barrier damage, worsening of the disease and, potentially, development of infection. Nocturnal scratching is an issue that leads to a significant impact on AD patients’ quality of life, including loss of sleep, irritability, difficulty concentrating and anxiety.1
To evaluate the potential ability of MM36 to provide rapid itch relief, the study utilized several validated pruritus measures including the Visual Analog Scale (VAS), Numeric Rating Scale (NRS) and Verbal Rating Scale (VRS). Patients were assessed during the first 24 hours and through day 29. Results demonstrated:
- Median time to itch improvement was 5.76 hours after MM36 application as reported using VRS2
- On average, by hour 4 patients achieved a 60% median reduction in pruritus which was sustained at day 29, as reported by VAS
Patients also reported improvements in sleep during the study, based on both the Patient-Oriented Eczema Measure (POEM) and Scoring Atopic Dermatitis (SCORAD) scales.
Efficacy
Additional exploratory endpoints included measuring improvement in disease severity as measured using Eczema Area and Severity Index (EASI) scores.
- Subjects achieved a 45% median reduction in EASI score by day 8 of the study, and reached 66% improvement by day 29
- Disease on the face, head and neck showed a median EASI score reduction of 81% by day 29
“The results of the Phase 2 study represent a potentially significant breakthrough in the treatment of AD. Current therapies, including newly released topical and systemic therapeutics, describe pruritus resolution in days or weeks. The Phase 2 study results of MM36 demonstrate the potential for itch relief in hours, which may improve both treatment outcomes and patient quality-of-life,” said Linda Stein Gold, MD, director of clinical research, Department of Dermatology at Henry Ford Hospital. “Considering both the early itch relief and observed safety findings, it appears that MM36 could address an important unmet need in AD management.”
“We believe these remarkable rapid itch relief results may be a key differentiating factor for MM36,” said Bradley Glassman, Chairman and Chief Executive Officer of Medimetriks. “We are committed to the continued development of MM36 with the goal of improving the lives of AD patients. We expect to hold our End of Phase 2 Meeting with the FDA later this year and start our pivotal trials in the first quarter of 2018, with a goal of filing an NDA in the second half of 2019.”
1 Simpson et al. The effects of treatment on itch in atopic dermatitis. Dermatologic Therapy 2013. Mar-Apr 26(2) 110-119.
2 ITT population. The endpoint “time to itch improvement” was defined as achievement of a VRS score of 0 to 1 with a 1 point reduction from baseline.
About MM36
Medimetriks has exclusive US rights to develop and commercialize MM36. Discovered by Otsuka Pharmaceutical at its Ako Institute in Japan and in development there as OPA-15406, MM36 is non-steroidal topical anti-inflammatory PDE4 inhibitor in development for the potential treatment of AD. 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 AD. In particular, MM36 exhibits highly selective inhibitory activity against PDE4 subtypes, particularly sub-type B, which 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.
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
View original content:http://www.prnewswire.com/news-releases/medimetriks-announces-phase-2-study-results-demonstrating-early-itch-relief-for-topical-pde4-inhibitor-mm36-in-patients-with-atopic-dermatitis-300513596.html
SOURCE Medimetriks Pharmaceuticals, Inc.
