MetrioPharms drug candidate MP1032 is currently in clinical phase II.
Phase II trial to treat moderate to severe chronic plaque psoriasis:
The first patient in the ongoing study was dosed in March 2018. This Phase II clinical trial is planned to enroll up to 150 male and female participants with chronic plaque psoriasis (PASI 10-20). Participants will be divided into three groups of 50 persons each. Approximately 14 study centers in Germany and Poland will participate in this study.
The Phase II study will be conducted as a multicenter, randomized, double-blind, placebo-controlled study with twice daily oral administration over 12 weeks. Psoriasis patients aged 18 to 70 years receive either MP1032 (150 mg or 300 mg) or placebo. The primary objective of this study is to evaluate the clinical efficacy and safety of MP1032 at different doses.
In March 2017, the phase IIa clinical trial in patients with moderate-to-severe chronic plaque psoriasis was successfully completed:
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. No serious side effects were observed in patients treated with MP1032.
Exploratory analysis of the drug's potential effect on PASI scores suggests a clinically relevant response in patients who entered the study with a PASI score of 10-20 and achieved appropriate MP1032 exposure levels.
In December 2015, the phase I clinical trial was successfully completed:
The results confirmed the preclinical data, which already indicated an outstanding safety profile. Even at 6 times the assumed therapeutically effective dose, no toxicity or intolerance was observed in the participants.