The US Food and Drug Administration (:FDA) recently cleared the Investigational New Drug Application (IND) for Omeros Corporation’s (OMER) OMS824 for treating patients suffering from Huntington's disease. OMS824 is Omeros’ lead compound in its phosphodiesterase 10 (PDE10) program.
In Mar 2013, Omeros reported positive results from a multiple-ascending-dose (:MAD) section of the company’s phase I study (n=64) on OMS824 for the treatment of Huntington's disease, schizophrenia and other central nervous system disorders. The study results revealed that OMS824 was well tolerated by all the volunteers. Moreover, the candidate effectively inhibited PDE10, which support continuing development for the treatment of Huntington's disease, schizophrenia and other central nervous system disorders.
Omeros also mentioned in its press release that it has requested for an Orphan Drug Designation from the FDA for OMS824 in the Huntington's disease indication. We remind investors the company has already requested the FDA to grant Fast Track Designation to the candidate in the same indication.
Omeros plans to advance OMS824 in a phase II development for the treatment of Huntington's disease in the third quarter of 2013. The company also intends to initiate a phase II study on the candidate for the treatment of schizophrenia later in the year. We note that OMS824’s IND for schizophrenia has already been cleared in the US.
Omeros, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Other biopharma stocks such as Jazz Pharmaceuticals (JAZZ), Santarus Inc. (SNTS) and Cubist Pharmaceuticals Inc. (CBST) currently look more attractive. While Jazz Pharma and Santarus carry a Zacks Rank #1 (Strong Buy), Cubist Pharma carries a Zacks Rank #2 (Buy).
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