Biospherics’ BSN175, is being developed as an oral treatment for glycemic control in patients with Type 2 diabetes and other indications. BSN175 has been recognized by the U.S. Food and Drug Administration (FDA) as a GRAS (Generally Recognized as Safe) substance for use in food. Biospherics completed a Phase 2 clinical trial studying the dose-response effect of minimal doses of BSN175 on glycemic control in subjects with Type 2 diabetes under diet control and exercise. It was a six-month, multi-center, single-blinded, randomized parallel study. Preliminary results of the trial were encouraging, with the group receiving 7.5 grams of BSN175 averaging a 0.3% reduction in HbA1c (blood glucose level) versus the group receiving 2.5 grams, and the group receiving 5.0 grams of BSN175 averaging a reduction in HbA1c of 0.05% versus the 2.5 gram group. In addition, triglycerides (a measurement of fat in the bloodstream) were reduced by 59 mg/dl, low-density lipoproteins (LDL, or “bad” cholesterol) were lowered an average of 13 mg/dl and high-density lipoproteins (HDL or “good” cholesterol) were raised an average of 0.9 mg/dl. The overall LDL:HDL ratio of the subjects in the trial improved by 0.3.
BSN175 was also studied as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes in a double-blind, randomized Phase 3 study. The study was powered to detect a 0.5% reduction in HbA1c as its primary endpoint, with secondary endpoints establishing glucose, insulin and lipid profiles and measuring changes in body weight. If approved, BSN175 is likely to receive at least five years of market exclusivity as a result of the Hatch-Waxman extension for new chemical entities.