) announced positive results from a phase IIa study on OMS824,
being evaluated for the treatment of schizophrenia. OMS824 is
Omeros' lead candidate in its phosphodiesterase 10 (PDE10)
The randomized, double-blind, placebo-controlled study
evaluated OMS824 at two dose levels for two weeks. The study
demonstrated comparable systemic pharmacokinetics when evaluated
alone and concurrently with approved antipsychotic agents in
schizophrenic patients. The data revealed that OMS824 was well
tolerated, with mild or moderate adverse events that were
self-limiting and were resolved during the treatment period. In
the high-dose arm, plasma concentration levels were similar to
those experienced in a phase I positron emission tomography (PET)
The positive data suggests that dose adjustment will not be
necessary when OMS824 is administered in combination with
standard antipsychotic medications.
We note that Omeros will begin enrolment in a phase II study
on OMS824 for the treatment of Huntington's disease in the
current quarter. OMS824 enjoys Orphan Drug status in the U.S. for
this indication. A Fast Track application is also under review in
the U.S. for OMS824 for the treatment of Huntington's disease and
We find the positive data from the schizophrenia study to be
encouraging. PDE10 has the potential to treat the positive and
negative symptoms of schizophrenia along with cognitive
On the back of encouraging data, Omeros is likely to evaluate
additional higher dose levels of OMS824 in schizophrenic
patients. OMS824 will now be developed as monotherapy or in
conjunction with other antipsychotics for schizophrenia and a
wide range of other psychiatric and neurologic disorders in phase
II and phase III of its schizophrenia program.
On the whole, we are encouraged by the pipeline progress at
Omeros. We note that Omidria (OMS302) is another interesting
candidate in Omeros' pipeline. The company is looking to get
Omidria approved in the U.S. and EU for the treatment of patients
undergoing intraocular lens replacement surgery. Omeros expects
to market Omidria in the second half 2014. Omidria is Omeros'
proprietary pharmacosurgery product and its most advanced
Omeros currently carries a Zacks Rank #3 (Hold). Some
better-ranked players in the pharma industry include
Forest Laboratories Inc.
). All the three stocks carry a Zacks Rank #1 (Strong Buy).
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