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news.US-based biopharmaceutical Omeros has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug application (IND) to assess its lead human monoclonal antibody OMS721 for the inhibition of complement-mediated thrombotic microangiopathies (TMAs).
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OMS721 targets mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system.
In 2013, the company had announced that the FDA granted OMS721 orphan drug status for the inhibition of complement-mediated TMAs, a family of rare, debilitating and life-threatening disorders characterized by multiple thrombi (clots) in the microcirculation of the body’s organs, most commonly the kidney and brain.
The clearance of the IND allows the start of the Phase II program for OMS721, which will evaluate the efficacy and safety of OMS721 in patients with disorders associated with lectin pathway activation.
The first OMS721 Phase II trial, scheduled to start later this quarter, will assess the effects of the drug on patients with TMAs, including atypical hemolytic uremic syndrome (aHUS), thrombotic thrombocytopenic purpura (TTP), and stem cell transplant-related TMA.
The lectin pathway is expected to play a major role in the development of TMAs, and OMS721, by targeting and inhibiting MASP-2, blocks the lectin pathway.
Omeros chairman and chief executive officer Gregory Demopulos said FDA’s decision clears the way for the company to start the Phase II program for OMS721.
"We are excited by the data in serum samples from aHUS patients, and we look forward to reporting results from our Phase 2 clinical trial in patients with aHUS and other TMAs later this year," Demopulos said.