MetrioPharm AG, a biotech company developing small molecule immune modulators for autoimmune and other inflammatory diseases, announces positive top-line results from its phase IIa trial with its proprietary drug compound MP1032 in patients with moderate-to-severe plaque psoriasis.
The phase IIa trial conducted at four clinical study sites in Germany was a randomized (1:1), double-blind, placebo-controlled, study with MP1032 given orally twice daily. Forty-four patients received six-weeks of treatment with placebo or MP1032 and were monitored for an additional four-week period.
The primary objectives of the study were to evaluate the safety and pharmacokinetics (PK) of twice daily 100 mg MP1032 in patients with moderate-to-severe plaque psoriasis. Enrolled patients had an average age of 40 years (21-65) and a median baseline PASI score of 13.6 (ranging from 10.1 to 40.8).
With regard to safety, the most frequently reported adverse events were common cold, headache, and itching. All events were mild to moderate and occurred in both the placebo and MP1032 group. There were no effects on lymphocytes or other blood-count parameters and no treatment-related gastro-intestinal adverse effects were reported. No serious or severe adverse events were reported in patients treated with MP1032. No patient treated with MP1032 discontinued the trial because of adverse events or tolerability issues.
Exploratory analyses regarding the potential effect of the drug on PASI scores suggest that patients with MP1032 exposure levels above 120 ng*hr/ml (n=16) have a median reduction from baseline in PASI score of 25 % as compared to 12 % in the placebo group at the end of treatment (week 6). Upon discontinuation of treatment, during the four-week follow up period, median PASI scores in the treatment group trended back upward while the placebo group remained relatively unchanged, suggestive of a therapeutic effect of MP1032.
“This phase IIa study suggests a clinically meaningful activity of MP1032 for the treatment of moderate-to-severe plaque psoriasis. From a clinical point of view, an oral drug with a better tolerability profile than currently available drugs, is desirable. I am looking forward to seeing how MP1032 performs in upcoming clinical trials,” said Prof. Wolfgang Vanscheidt, one of the study’s Principal Investigators.
Dr. Wolfgang Brysch, CEO of MetrioPharm said “The positive results from this trial represent an important milestone in our development program for MP1032. We are very pleased that MP1032 was well tolerated and that there is a meaningful trend in response after only six weeks of treatment. We believe that MP1032 could become an effective, and well-tolerated oral treatment option for patients suffering from moderate-to-severe forms of psoriasis”.
Based on the wide pre-clinical safety margin of the drug, the PK data in psoriasis patients, and the trend in drug effect observed in this trial, MetrioPharm is planning a three-month phase IIb study in patients with moderate-to-severe plaque psoriasis with higher doses of MP1032.