MetrioPharm AG, a clinical stage biopharmaceutical company, reports positive results from its recently completed Phase II dose finding study of MP1032 in psoriasis patients. The data confirm the trend towards clinical efficacy and outstanding safety profile of MP1032, the lead compound from a new class of proprietary immune modulators developed by MetrioPharm AG.
A total of 155 patients were randomized to two doses (150 mg b.i.d. and 300 mg b.i.d.) and a placebo arm in the MP1032-CT04 study. The primary objectives were the efficacy and safety profile of the two doses of oral MP1032. Two co-primary endpoints were a response in PASI 75 at Week 12 and an improvement in PGA at Week 12.
The overall response rate (defined as PASI 50 and 75) more than doubled over placebo with even a 4-fold increase in PASI 75 responders. Because of the limited overall number of patients enrolled in the trial a statistical significance improvement in efficacy could not be established.
An additional finding was that high dose MP1032 showed a statistically significant reduction in all-cause AEs over placebo thereby confirming the expected benign safety profile.
Wolfgang Brysch, CEO of MetrioPharm AG commented on the results: „We are excited about the results of this trial. As a dose-finding study it has clearly demonstrated a dose-response and informed on optimal dosing in future development.
With respect to drug safety, the results clearly exceeded our expectations. There were no serious adverse events in both treatment arms. What’s more: In the higher dose group there was a statistically significant decrease in concomitant non-psoriasis-related diseases in signs and symptoms compared to the placebo arm. This implies that MP1032 may actually have a general health promoting effect, well above its indication-specific therapeutic effect. This positions the product for potential chronic administration in age-related conditions.”
MP1032 has shown comprehensive preclinical results in a wide range of age-related diseases like arthritis, neurodegenerative diseases, and inflammatory bowel disease. Oxidative stress has been identified as a key driver of inflammation in all these age-related degenerative diseases (“inflamm-aging”). Wolfgang Brysch: “The MP1032-CT04 study was undertaken to test if targeting oxidative stress produces an anti-inflammatory and disease modifying effect. Psoriasis was chosen as the target disease to demonstrate that disease modification is attainable by controlling oxidative stress. Furthermore, the novel auto-regulatory drug mechanism of MP1032 seems to be very safe and to have a general health-promoting effect. MetrioPharm AG will now use this data to determine which clinical path forward will best realize our opportunities.”