Theracos Reports Positive Outcomes from a 96-Week Phase 2 Study of THR1442, a Highly Specific SGLT2 Inhibitor, for the Treatment of Type 2 Diabetes
- Category: Small Molecules
- Published on Monday, 17 March 2014 16:10
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MARLBOROUGH, MA, USA I March 17, 2014 I Theracos, Inc., www.theracos.com , a privately held biotechnology company located in Marlborough, Massachusetts, today announced the results of a multinational 96-week Phase 2 study evaluating the efficacy and safety of the SGLT-2 inhibitor THR1442. The double-blinded, placebo-controlled study enrolled a total of 288 subjects with Type 2 diabetes from sites in the US, Mexico and Colombia and evaluated the efficacy of THR1442 compared to placebo as a monotherapy for the treatment of diabetes.
“We are extremely pleased with the results of this study” said Dr. Albert Collinson, President and CEO of Theracos. “It confirms our view that THR1442 has the potential to be a highly efficacious oral antidiabetic medication that lacks the major recognized liability of the SGLT2 class. Theracos believes that the disposition of excess bloodstream glucose into urine represents a fundamentally superior approach to the treatment of diabetes compared to disposition into fat, inasmuch as a hypertrophic adipose reservoir is typically the most important causative factor in the development of type 2 diabetes. We believe the product profile demonstrated in this clinical study significantly differentiates THR1442 from other compounds in the class.”
The primary efficacy endpoint was change in HbA1c at week 24. Treatment with THR1442 resulted in a statistically significant lowering of HbA1c, relative to placebo, of 0.79%, a difference that increased to 1.02% following 96 weeks of treatment. The proportion of subjects achieving an HbA1c level of less than 7% following 24 weeks of treatment was 24% in the THR1442 arm versus 11% in the placebo arm. At 96 weeks of treatment, the proportion of subjects achieving an HbA1c level of less than 7% further improved to 31% in the THR1442 arm versus 11% in the placebo arm. Randomized subjects participating in the study included roughly 10% that were treatment naïve, equally distributed between the THR1442 and placebo arms.
SGLT2 inhibitors as a class have been reported to increase the rate of genital mycotic infections, particularly among female subjects, for whom incidences approaching 20% have been recorded following treatment with other compounds in the class for durations similar to or shorter than that of this study. In this large trial, THR1442 produced no increase in genital infection rates relative to the placebo arm following 96 weeks of treatment. The overall genital infection rate was 2.13% in the placebo arm and 2.07% in the THR1442 arm at study conclusion. An approximately equal number of males and females were exposed to placebo or active agent, and urinary tract infection rates were higher in the placebo arm than in the THR1442 arm.
The incidence of asymptomatic hypoglycemia was comparable in both the placebo and treatment arms and no severe hypoglycemic events were observed. Patients treated with THR1442 achieved meaningful and sustained reductions in both diastolic and systolic blood pressure, as well as significant and durable weight loss in this study.
Theracos, Inc. is a privately held pharmaceutical research and development company founded in 2000 and located in Marlborough, Massachusetts. Theracos is engaged in the discovery and development of novel therapeutics in areas of unmet medical need.