Novel Topical AD Drug Shows Promise in Phase 2 Study

Medimetriks’ MM36 (previously known as OPA-15406) performed well in a Phase 2 trial for the treatment of mild-to-moderate atopic dermatitis, a new study in in Journal of the American Academy of Dermatology shows.

The investigational topical phosphodiesterase 4 (PDE4) inhibitor is being developed by Medimetriks in collaboration with Otsuka.  It is expected to be the 2nd topical PDE4 inhibitor available in the US after the potential approval of Anacor Pharmaceuticals' crisaborole product.

MM36 exhibits highly selective inhibitory activity against PDE4 subtype B, an enzyme that may play a significant role in inflammation.

In the randomized, double-blind, vehicle-controlled study of 121 patients, MM36 demonstrated a statistically significant effect on the primary endpoints versus vehicle as measured by improvement in Investigators Global Assessment (IGA) and percentage change in Eczema Area and Severity Index (EASI).  The mean percentage improvement in baseline EASI score was notable very early at week 1 (31.4 percent vs. 6 percent for vehicle; p=.0005) and at week 2 (39.0 percent vs. 3 percent for vehicle; p=.0001).  These effects were sustained through week 8 of the study. 

Moreover, MM36 was also associated with improvement 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 (36.4 percent mean change; p=.0011).