By Peter Loftus
Gilead Sciences Inc. (GILD) has discontinued development of a
treatment for a rare lung disease after it failed to meet its
efficacy goal in a clinical trial.
The drug, cicletanine, was being evaluated in a midstage, or
Phase 2, study of people with pulmonary arterial hypertension,
which involves high blood pressure in the arteries of the lungs and
causes shortness of breath.
The study's primary efficacy goal was to track whether
cicletanine could help patients walk farther in six-minute tests,
after 12 weeks of treatment, versus a placebo.
The trial, which began in 2009 and was targeted to enroll 160
patients, was terminated because it didn't meet the primary
endpoint, according to an update posted Monday on
clinicaltrials.gov, an online database of clinical trials run by
the U.S. National Institutes of Health.
Gilead communicated the outcome to study investigators and the
PAH medical community earlier this year, spokesman Nathan Kaiser
said Tuesday.
"As a result, Gilead will not pursue further development of
cicletanine for PAH," Kaiser said.
Gilead had acquired cicletanine in 2008 from Navitas Assets LLC
for an initial payment of $10.9 million, plus the potential for
future payments if certain development and regulatory milestones
were met. The deal gave Gilead rights to cicletanine as a
monotherapy for PAH and other indications in the U.S.
Cicletanine was developed by Ipsen (IPN.FR) and is approved in
certain European countries for hypertension, according to
Gilead.
Gilead shares were up six cents at $56.55 in recent trading.
Write to Peter Loftus at peter.loftus@dowjones.com
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