Sirtris Pharmacueticals reported the results of its second Phase 1b clinical study yesterday on SRT501, which involved twice daily dosages of 1.25 grams and 2.50 grams. This study follows up on the safety results of the first study, released this past January, of a single daily doses of 2.50 grams and 5.0 grams. The only difference between the two clinical trials were a single daily dose versus a twice daily dose of the same aggregate daily dosage. Both clinical results demonstrated no significant safety issues. Both studies also showed a lowering of glucose in Type 2 Diabetic patients and signs of efficacy and dose response although the primary focus of the studies were safety.
While this is good news it is hardly unexpected given the safety results of the first study. The more important test of SRT501's viability, will be later on this year when phase 2a data on the effectiveness of SRT501 in combination with the standard of care, metformin will be released. Even if SRT501 does well in this 2a trial, SIRT's 1,000 times more potent NCE may be the more likely candidate to become a stand alone diabetes drug candidate.
In any case, it is the potential of the vastness of the sirtuin platform and the role that Sirtris seemingly plays as gatekeeper with its numerous patents, that makes this a very promising play in biotechnology.
Do your own due diligence.
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