MetrioPharm – Milestones on the route to a new drug

The R&D team of MetrioPharm AG was able to complete a number of important projects on the finishing straight of 2013, most notably the regulatory pre-clinical study package.

The most important outcome was MP1032’s superior safety profile as confirmed by the results from the various regulatory pharmacology and toxicology studies conducted throughout the past year. This extensive testing programme according to international regulatory standards was designed to assess the safety and possible side-effects of MP1032. Such tests are the prerequisite for a first-in-man Phase I clinical study with any new drug. As part of this test programme, MP1032 has been investigated in two different animal species for its tolerability in different dosages over extended periods of time. The results of these tests surpassed even our own ambitious expectations. Repeated daily administration of up to 150(!) times the normal therapeutic dose for 28 consecutive days did not cause any side-effects or adverse events whatsoever. Not even tried and tested drugs like Aspirin have such a high safety margin.

A clean safety profile is a highly valuable asset for a new drug since safety considerations are of ever increasing importance to regulators during the coming process of clinical testing and prospects for future market approval.

With the impeccable animal safety data obtained for MP1032 we have laid an important foundation for entering clinical Phase I trials in 2014. For the first time, MP1032 can now be tested directly in humans in order to prove the safety of this promising new drug in man.