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news.Sirtris Pharmaceuticals has initiated a Phase Ib clinical trial of an experimental treatment in patients in Europe with MELAS syndrome, a rare genetic disorder.
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MELAS syndrome (mitochondrial encephalopathy lactic acidosis and stroke-like episodes) is a progressive and fatal disorder caused by a mutation in the DNA of the mitochondria that mainly affects muscles and nerves leading to reduced exercise capacity and eventually muscle failure. There are currently no known treatments for patients with the condition.
This Phase Ib trial is designed to test the primary endpoints of safety and pharmacokinetics of SRT501 in patients with MELAS. SRT501 will be administered to a group of 15 patients once daily for three months and an additional group of 15 patients will receive placebo. Secondary endpoints include exercise tolerance, and fasting blood glucose and insulin levels. Sirtris expects data from this trial by the end of 2008.
“In addition to MELAS, SRT501 is also being evaluated in two Phase Ib clinical trials in patients with type II diabetes with results expected in the first of these trials later this year. SRT501 represents the first in a portfolio of sirtuin activators, including novel chemical entities which are even more potent than SRT501, intended to treat a range of diseases of aging,” said Christoph Westphal, CEO of Sirtris.