Gilead Discontinues Development of Cicletanine

Dow Jones reported yesterday that Gilead Sciences have dropped the diuretic cicletanine after it failed to meet targets in a mid-stage clinical trial analysing the drug’s potential in high blood pressure.

The Phase II, randomised, double-blind, placebo-controlled, multicenter, dose- ranging study was evaluating the efficacy, safety and tolerability of cicletanine in comparison to a placebo in patients with pulmonary arterial hypertension.

However the trial, which enrolled 162 patients across 56 different sites, failed to reach the primary endpoint (the change in distance travelled by patients from the baseline in six minutes of walking after 12 weeks of treatment) and has been now been listed as ‘discontinued’ on the website.

As a result of the study results, Gilead is discontinuing its development of the drug.

Patients with pulmonary arterial hypertension (PAH) have continuous high blood pressure in the pulmonary artery that carries blood from the right ventricle in the heart to the small arteries in the lungs.  The passages narrow and thicken, and scar tissue and blood clots can form, frequently leading to failure on the right hand side of the heart.

There are already treatments available for patients with PAH, including the Gilead drug Letairis, but the disease currently does not have a cure.  Nearly 1,000 new cases of pulmonary arterial hypertension are diagnosed yearly in the US.

Gilead Sciences paid an upfront payment of $10.9 million to Navitas Assets in 2008 for cicletanine, which was originally developed by French drug maker Ipsen.


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