MP 1032 Milestones - on the route to a new drug
Looking back, 2013 has been the most successful year in MetrioPharm's history. All decisive milestones in our development plan for the year have been achieved – many even surpassed.
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-eff ects of MP1032. Such tests are the prerequisite for a fi rst-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 diff erent dosages over extended periods of ti me. The results of these tests surpassed even our own ambitious expectations.
Repeated daily administrati on of up to 150(!) times the normal therapeutic dose for 28 consecutive days did not cause any side-eff ects or adverse events whatsoever. Not even tried and tested drugs like Aspirin have such a high safety margin. A clean safety profi le 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.
Patents – successful granting in Switzerland
Another important milestone was the granting of our core substance patent in Switzerland. Thus MetrioPharm AG was able to make good progress in its R&D programme and to further protect its future commercial success.
As the company's pipeline- and clinical development will expand and speed-up in the upcoming years, MetrioPharm has created a new position for investor relations. Starting in January 2014, Mrs. Joana Loens has joined us at our Berlin R&D site to assure ti mely communicati ons of important developments directly to our investors and shareholders, who now have a dedicated personal contact.
MetrioPharm AG's R&D staff is also growing along with its advancing development acti vities. Starting in February, Dr. Claudia van Laak will complement our team with her immunological expertise.
MetrioPharm AG will present data on the potential of MP1032 in autoimmune diseases at the 9th Internati onal Concress on Autoimmunity, held form March 26. – 30. in Nice, France.