MetrioPharm AG, a pharmaceutical development company, announces that it has enrolled the last patient with moderate-to-severe plaque psoriasis (PASI entry score 10-20) in its ongoing Phase II clinical trial (Last-Patient-In).
The Phase II trial conducted in Germany and Poland is multi-centered, randomized, double-blinded and placebo-controlled. A total of 154 patients are receiving either MP1032 (150 mg or 300 mg) or a placebo twice daily. The primary objective is to evaluate the clinical efficacy and safety of MP1032 at various doses.
Dr. Wolfgang Brysch, CEO of MetrioPharm AG: "The recruitment of volunteers has now been completed to our great satisfaction. I would like to thank the MetrioPharm team, our study partner Bioskin and all trial centers. In psoriasis studies you are always dependent on the weather. Much sunshine alleviates the symptoms of patients and their propensity to participate in studies decreases significantly. Together, all employees have worked very focused on ensuring that our recruitment could be completed successfully despite the so-called summer of the century".
Dr. Petra Schulz, Senior Manager Drug Development: "The patients just enrolled now have a regular treatment period of twelve weeks followed by a four-week monitoring. We will then be able to begin validating and evaluating all data. We expect the results of the study in the course of 2019".
MP1032 is the lead compound of a class of proprietary immune modulators developed by MetrioPharm. MP1032 is believed to modulate the oxidative stress-mediated activation state of macrophages and downregulate the M1 state. In contrast to other immune-modulating and disease-modifying drugs, MP1032 does not impact T-cells and preferentially affects macrophages at the sites of inflammation. MP1032 has shown anti-inflammatory activity in animal models of disease and a favorable toxicology profile in pre-clinical studies. For the first Phase II study with MP1032, the indication psoriasis was selected because this immune-induced inflammatory disease is regarded as a so-called »door-opener indication«. Successes in the treatment of psoriasis have already led to first indications of promise for use in other chronic inflammatory diseases, such as arthritis and multiple sclerosis.