Loading...
Loading...
Arena Pharmaceuticals, Inc.
today announced the completion of a Phase 1b clinical trial for APD811,
an investigational oral prostacyclin (IP) receptor agonist intended for the
treatment of pulmonary arterial hypertension (PAH). The company plans to
initiate a Phase 2 clinical trial for APD811 in the first quarter of 2014.
"Arena's internal GPCR-focused efforts led to the discovery of this novel drug
candidate," said William R. Shanahan, M.D., Arena's Senior Vice President and
Chief Medical Officer. "We believe APD811 is a promising new chemical entity
that could improve current patient care by providing an oral option for
IP-targeted therapy. Based on the encouraging Phase 1 results, we look forward
to initiating the Phase 2 program early next year."
This randomized, double-blind and placebo-controlled Phase 1b clinical trial
evaluated the safety, tolerability and pharmacokinetics of multiple-ascending
doses of APD811. Arena previously evaluated single-ascending doses of APD811
in a Phase 1a clinical trial.
In the Phase 1b clinical trial, 40 healthy volunteers received APD811 and 15
received placebo, and the safety profile of APD811 was characteristic of IP
receptor agonists. No serious adverse events were observed, and the most
frequent treatment-emergent adverse events were headache, nausea and jaw pain.
The results of the Phase 1 program led to the decision to proceed with Phase 2
development of APD811, which will include further exploration of dosing
regimens in PAH patients.
Loading...
Loading...
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in