) recently announced that the company has filed an Application
for Orphan Drug Designation with the US Food and Drug
Administration (FDA) for its candidate OMS721.
OMS721 is the leading human monoclonal antibody for Omeros'
mannan-binding lectin-associated serine protease-2, or MASP-2
The filing comes close on the heels of the positive
preclinical data announced by the company on OMS721 in a model of
thrombotic microangiopathy (TMA) earlier in the month.
We note that TMA is a disorder in the microcirculation of the
body's organs, in particular the kidney and brain.
Omeros plans to initiate clinical trials for OMS721 initially
for use in the treatment of atypical hemolytic uremic syndrome
(aHUS), which is a rare and dangerous form of TMA.
Omeros plans to file for the same designation in Europe as
well. We note that
) Soliris is also indicated for aHUS.
Meanwhile, in another positive development, Omeros announced
positive results from the multiple-ascending-dose (MAD) section
of the company's phase I study on OMS824 in Mar 2013. We note
that OMS824 is the lead compound in Omeros' phosphodiesterase 10
In Dec 2012, Omeros reported promising data from the
single-ascending-dose (SAD) study portion of a phase I study on
OMS824. Based on the positive data published by the company on
OMS824 in Dec 2012 and Mar 2013, it now plans to advance the
candidate into phase II development.
Omeros is developing the candidate as a PDE10 inhibitor, which
is an enzyme expressed in areas of the brain linked to a wide
range of diseases, including Huntington's disease and
schizophrenia, that affect cognition.
Omeros, a biopharmaceutical company, currently carries a Zacks
Rank #3 (Hold). Right now,
) look well placed with a Zacks Rank #1 (Strong Buy).
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