Amira Pharmaceuticals Announces Initial Positive Phase 1 Clinical Data for AM461, A Back-Up to Amira's Lead DP2 Antagonist, AM211
Results Demonstrate Positive Proof of Mechanism
SAN DIEGO, Dec. 3 /PRNewswire/ -- Amira Pharmaceuticals, Inc.
announced today initial positive data from a Phase 1 clinical study
of AM461, the Company's second oral selective antagonist of the DP2
(also known as CRTH2) receptor.
The interim results demonstrate that a dose proportional
pharmacodynamic (PD) effect can be achieved with AM461.
Additionally, AM461 Phase 1 data to date demonstrates a good safety
profile. AM461 is a back-up to Amira's lead DP2 antagonist, AM211,
which has successfully completed Phase 1 clinical studies.
"The AM461 clinical data further strengthens our commitment to
the DP2 receptor as a clinical target. Amira now has two
structurally distinct, clinical-stage compounds targeting the
receptor," said Isabelle DeArmond, Vice President, Clinical
"Our approach to drug development is based upon bringing
multiple structurally and metabolically distinct compounds forward
in development. In addition to AM211 and AM461, we have additional
novel DP2 antagonist molecules in reserve," said Bob Baltera, Chief
While there are no DP2 selective antagonists approved for
therapeutic use, there is a strong scientific rationale for this
target to be a novel treatment of asthma, chronic obstructive
pulmonary disease (COPD) and allergic rhinitis. A DP2 antagonist
has the potential to be disease modifying in these aforementioned
conditions. DP2 is also known as CRTH2, or chemoattractant
receptor-homologous molecule expressed in Th2 lymphocytes. DP2 is a
high affinity receptor for the prostaglandin D2 and in humans is
implicated in Th2-dependent allergic inflammation.
Founded in 2005 and headquartered in San Diego, Amira
Pharmaceuticals is a small molecule pharmaceutical company focused
on the discovery and early development of new drugs to treat
inflammatory disease. Our discovery team is building on
unparalleled insights into bioactive lipid pathways and complex
signaling processes controlling many conditions including asthma,
chronic obstructive pulmonary disease, cardiovascular and fibrotic
Amira has a partnership with GlaxoSmithKline for the development
of FLAP (5-lipoxygenase activating protein) inhibitors in
respiratory and cardiovascular disease. Amira combines the rigor of
a big pharmaceutical company with the ingenuity and energy of a
small company, creating an environment for efficient development of
novel compounds and effective pre-clinical and clinical program
decisions. Its scientific founders have successfully worked
together for more than a decade and were pivotal in the discovery
of a number of inflammatory drugs, including Singulair®. The
drug hunters at Amira are now actively leveraging their history of
success to create high-value compounds for the future. For more
information, visit www.amirapharm.com.
Source: Amira Pharmaceuticals, Inc.
Posted: December 2009