US-based dermatology company Medimetriks Pharmaceuticals has reported positive results from a Phase ll trial of MM36 to treat mild-to-moderate atopic dermatitis (AD).
AD is a chronic inflammatory skin condition characterised by red, swollen and cracked skin with intense itching and it mostly occurs between three and six months of age.
A total of 121 patients were enrolled in the randomised, double-blind, vehicle-controlled trial jointly conducted by Medimetriks and Otsuka Pharmaceutical.
MM36, the topical, non-steroidal phosphodiesterase IV (PDE4) discovered by Otsuka, demonstrated a statistically significant effect on the primary endpoints versus vehicle during the trial as measured by improvement in Investigators Global Assessment (IGA) score and percentage change in Eczema Area and Severity Index (EASI) score.
The mean percentage improvement in baseline EASI score was prominent very early at week one and at week two.
These effects were sustained through week eight of the trial.
MM36 was also associated with progress in patient-reported outcomes, most notably rapid and sustained itch relief, with visual analog scale scores showing improvement from moderate to mild within the first week.
Medimetriks noted that MM36 reduces inflammation in affected skin by inhibiting production of cytokines and chemical mediators that are believed to cause the signs and symptoms of atopic dermatitis.
MM36 particularly demonstrates highly selective inhibitory activity against PDE4 subtype B, an enzyme that may play a significant role in inflammation.
It is reported that Anacor Pharmaceuticals’ crisaborole product was already approved and MM36 is expected to be the second topical PDE4 inhibitor in the market.
Henry Ford Hospital, US, department of dermatology clinical research director Dr Linda Stein Gold said: "The results of the Phase ll study suggest that MM36 represents a potentially safe, effective and well-tolerated, non-steroidal treatment for mild-to-moderate atopic dermatitis.
"Based on the results of this study, it appears that MM36 could address an important unmet need in dermatology."