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Omeros into phase 1 clinical trial in Europe

Authored by James Sheppard

The US biotech Omeros Corporation announced that they had filed a clinical trial application with the EMA to initiate clinical trials to evaluate OMS721. The companies lead monoclonal antibody, OMS721, is indicated for atypical haemolytic uremic syndrome (aHUS). AHUS is a rare but life-threatening form of thrombotic microangiopathy (TMA). Assuming that Omeros receives a positive regulatory review the company plans to commence trials in Q3 2013.

The phase 1 clinical trial will be a placebo controlled trial in healthy patients. Immediately after the completion of the study, Omeros plans to advance OMS721 into phase II trials in aHUS patients. OMS721 was developed from the company’s lead program, mannan-binding lectin-associated serine protease-2 (MASP-2). Omeros owns all worldwide rights to MASP-2 programs.

The drug will compete with the only approved treatment for aHUS which is Alexion’s $300,000 a year drug, Soliris. The drug has a number of distinct advantages over Soliris. Omeros CEO, Gregory Demopulos stated in a press release ‘MASP-2 is believed to be a key player in a large number of complement-mediated disorders, and we are initially focusing on aHUS and other TMAs. Here OMS721 has a potential therapeutic advantage over Soliris – in addition to its role in complement activation, MASP-2 is also directly involved in the coagulation cascade. Across all of its potential indications, we believe that OMS721’s potential safety profile and its ability to be dosed subcutaneously provide it with significant competitive advantages.’

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