Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Earlier this week, Omeros Corporation (OMER) suffered a pipeline setback with the company announcing the suspension of enrollment in a phase II study evaluating OMS824, a phosphodiesterase 10 (PDE10) inhibitor, for Huntington's disease. Shares fell 12.3% on the news. Omeros had initiated this study for the treatment of Huntington's disease earlier this year.
Omeros took this decision based on communications with the FDA and intends to further evaluate an observation from a 13-week preclinical study in rats. In the preclinical study, it was found that several rats receiving the maximum dose of OMS824 demonstrated free-plasma concentrations that multiplied higher than those measured in patients. The company will also assess data from other preclinical studies that did not show the above mention observation to understand the effects of OMS824 better before reinitiating the phase II study.
The company does not believe that the observation in the 13-week preclinical rat study is associated with the use of OMS824 as no such events were observed in previous clinical and preclinical studies.
Apart from Huntington's disease, OMS824 is also being developed for schizophrenia and other cognitive disorders. OMS824 has orphan drug status in the U.S. for Huntington’s disease and Fast Track status for the treatment of cognitive impairment in patients suffering from the disease.
Some stocks that can be considered in the health care sector include Ligand Pharmaceuticals Inc. (LGND), Medivation Inc. (MDVN) and Auxilium Pharmaceuticals, Inc. (AUXL).
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