Sirtris Pharmaceuticals, Inc. that announced SRT501 (Proprietary Version of Resveratrol), apart from being safe and well tolerated, also significantly lowered glucose in an oral glucose tolerance test in a Phase 1b, 28-day, clinical trial with patients who had Diabetes Type 2. The company presented its clinical trial data at the 26th Annual JPMorgan Healthcare Conference, San Francisco, USA.
The aim of the 28-day Phase 1b trial was to assess the safety, tolerability and pharmacokinetics of once-daily, oral doses of SRT501, either 2.5g or 5g, with Diabetes Type 2 patients who were naïve to other diabetes drug treatments.
Both the 2.5g and 5g doses were found to be safe and well-tolerated. The drug levels in the blood (pharmacokinetics) were the same at days 1 and 28, indicating that there was no accumulation. No serious adverse events or dose-related adverse events were detected. Notably, there was a statistically substantial improvement in an oral glucose tolerance test on the 28th day at two hours, plus a trend towards lower fasting plasma glucose levels.
SRT501 is also being tested in a Phase 2a study in combination with metformin. Metformin is the current first-line therapy for Diabetes Type 2. SIRT1 is the founding member of the human sirtuin family of enzymes which control the aging process. Specifically, SRT501 acts by increasing mitochondrial activity and therefore is targeted to address metabolic diseases, such as Type 2 Diabetes.
Peter Elliott, Ph.D., Senior Vice President of Development at Sirtris, said “This is the first time that a small molecule targeting sirtuins, the genes which control the aging process, has shown efficacy in a disease of aging. These Phase 1b study results are an important step forward for Sirtris because they represent significant progress in our clinical development of sirtuin therapeutics. We are very pleased to see the safety profile observed in preclinical studies translate into a well-tolerated drug molecule in patients, and we are very encouraged by the glucose lowering effects measured in the oral glucose test.”
Christoph Westphal, M.D., Ph.D., CEO and Vice Chair of Sirtris, said “Effective treatment for Type 2 Diabetes, a disease of aging, is an unmet medical need and sirtuin therapeutics may offer significant potential. SRT501 may represent a promising treatment option for these patients. We look forward to obtaining the results from our other Phase 1b clinical trial and the results from our Phase 2a clinical trial later this year.”
Written by – Christian Nordqvist