MetrioPharm AG has submitted the phase I investigational new drug application for MP1032
Zurich/Berlin, Nov 20, 2014. MetrioPharm AG has submitted the phase I investigational new drug application for its lead compound MP1032 to BfArM (German Federal Institute for Drugs and Medical Devices).
"With this filing, we have reached an important milestone in our development program," commented MetrioPharm's president, Dr. Wolfgang Brysch.
MP1032 has a marked anti-inflammatory effect while at the same time inhibiting bacterial and viral infections. This combined effect sets MP1032 apart from other currently used potent anti-inflammatory drugs, all of which increase patients' susceptibility to infections as an undesired side effect.
The Phase I study for MP1032 is being carried out in cooperation with SocraTec R&D GmbH, and will investigate the drug's safety, tolerability and pharmacokinetics in healthy volunteers.
"We expect to confirm the superior safety profile of MP1032 in man," added Dr. Brysch.
The study is scheduled to start in Q1/2015; first results are expected in Q2/2015. MetrioPharm AG plans to initiate a Phase Ib proof-of-concept study immediately afterwards in which MP1032 will be administered to patients with psoriasis and osteoarthritis.
"This clinical program allows us to obtain a rapid proof-of-concept of the efficacy of MP1032 in addition to an evaluation of its safety. This will be an important step forward on the road to approval and generate an immediate significant value increase for the company and our investors," said Dr. Brysch.