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ARTICLE | Clinical News

Theracos' SGLT2 inhibitor meets in Phase II trial

March 17, 2014 11:29 PM UTC

Theracos Inc. (Marlborough, Mass.) said oral THR1442 met the primary endpoint of reducing HbA1c from baseline to week 24 vs. placebo in a Phase II trial to treat Type II diabetes (p<0.0001). THR1442 also met the secondary endpoints of a greater proportion of patients achieving an HbA1c of less than 7% at week 24 (24% vs. 11%, p=0.0041) and at week 96 (31% vs. 11%, p<0.0001) vs. placebo. The double-blind, international trial enrolled 288 Type II diabetics inadequately controlled by diet and exercise and up to one oral anti-diabetic agent. THR1442 is a sodium-glucose cotransporter 2 (SGLT2) inhibitor.

According to Theracos, a predisposition for genital and genitourinary infections is the "major recognized liability" of other SGLT2 inhibitors. In the Phase II trial, THR1442 produced fewer urinary tract infections and slightly fewer genital mycotic infections (2.07% vs. 2.13%) compared to placebo after 96 weeks of treatment. According to Theracos, the rate of genital mycotic infections for other SGLT2 inhibitors for similar or shorter durations has been reported to be about 20%. The company said the absence of such infections represents a "major differentiating factor" in favor of THR1442. ...