FDA Clears Omeros' IND For OMS721 In Thrombotic Microangiopathies
Omeros Corporation announced the FDA clearance of its Investigational New Drug (IND) application to assess OMS721 for the inhibition of complement-mediated thrombotic microangiopathies.
Gregory Demopulos, chairman and CEO of Omeros, said, “FDA's decision clears the way for us to begin the Phase 2 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.”
OMS721 is the company’s lead human monoclonal antibody that targets the immune system’s lectin pathway key regulator called mannan-binding lectin-associated serine protease-2 (MASP-2). “FDA's clearance of the IND allows the initiation of the Phase 2 program for OMS721, which will assess the efficacy and safety of OMS721 in patients with disorders associated with lectin pathway activation. The first OMS721 Phase 2 clinical trial, planned to begin later this quarter, will evaluate 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… OMS721 significantly inhibited complement deposition both in the acute phase of the disease and during remission, and its inhibitory effect was similar to that of agents that block complement factor C5,” the company stated in its press release.
The lectin pathway is believed to play a central role in the development of TMAs. It is one of the principal complement activation pathways in the immune system. OMS721 blocks the lectin pathway by targeting and inhibiting MASP-2, a novel pro-inflammatory protein target involved in the complement system activation. The complement system plays a role in inflammatory response and is activated due to tissue damage or microbial infection. OMS721 contains MASP-2 antibody and is designed to be self-administered via subcutaneous injection.
The FDA has previously granted Orphan Drug Designation for OMS721 for the inhibition of complement-mediated TMAs last year.