MetrioPharm reported positive results from a Phase 2a clinical trial evaluating its drug candidate MP1032 in patients with moderate to severe plaque psoriasis, and now plans to conduct a Phase 2b trial.
The randomized, double-blind, parallel, placebo-controlled pilot clinical trial (NCT02908347), evaluated the safety, effectiveness and drug properties of oral MP1032 (100 mg, twice-daily) in patients with moderate to severe psoriasis over a period of six weeks.
Secondary endpoints included the evaluation of clinical parameters for psoriasis. The study included a four-week follow-up period to further assess the effects of treatment.
Enrollment in the trial included 44 patients (40 completed) with moderate to severe chronic plaque psoriasis with an average age of 40 (ages 21 to 65) and a median baseline PASI score of 13.6 (ranging from 10.1 to 40.8). The PASI score is a tool used to measure the severity and extent of psoriasis.
MetrioPharm reported that the trial had no tolerability or safety issues, with the most commonly reported adverse events observed being cold, headache, and itching.
In terms of MP1032’s effectiveness, the results showed that at six weeks, the 16 patients whose treatment had exposure levels above 120 ng*hr/ml experienced a 25% reduction in PASI score compared to 12% in the placebo group.
During the four-week follow-up period, and after patients stopped taking the drug, median PASI scores in patients treated with the investigational drug trended back upward while the scores remained unchanged in patients treated with the placebo drug. This observation suggests that the drug had a therapeutic effect on patients.
“This phase IIa study suggests a clinically meaningful activity of MP1032 for the treatment of moderate-to-severe plaque psoriasis,” Wolfgang Vanscheidt, one of the study’s principal investigators, said in a press release. “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.”
MetrioPharm CEO Dr. Wolfgang Brysch said the positive results from the trial represent an important milestone in MP1032’s development program.
“We are very pleased that MP1032 was well tolerated and that there is a meaningful trend in response after only six weeks of treatment,” Brysch said. “We believe that MP1032 could become an effective and well-tolerated oral treatment option for patients suffering from moderate-to-severe forms of psoriasis.”
MP1032 is an immune modulator of the H2O2-mediated activation state of macrophages (immune system cells) and down-regulates the M1 state, targeting inflammation.
Based on these positive results, MetrioPharm is planning to conduct a three-month Phase 2b trial to evaluate higher doses of MP1032 in patients with moderate to severe plaque psoriasis.