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Gilead Sciences discontinued development of cicletanine in pulmonary arterial hypertension (PAH) after the therapy failed to meet its efficacy goal in a Phase II study. The trial, which enrolled 162 patients with PAH, was designed to determine whether cicletanine could help patients walk further in a six-minute test after 12 weeks of treatment compared to placebo.
Spokesman Nathan Kaiser said that Gilead communicated the outcome to study investigators and the PAH medical community earlier this year and "as a result, Gilead will not pursue further development of cicletanine for PAH."
Gilead acquired cicletanine in 2008 from Navitas Assets for an initial payment of $10.9 million, plus the potential for future payments if certain development and regulatory milestones were met. The agreement gave Gilead rights to cicletanine as a monotherapy for PAH and other indications in the US. The drugmaker noted that the therapy, which was developed by Ipsen, is approved in certain European countries for hypertension.
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