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The compound is an NCE originally developed by the Hebrew University of Jerusalem. We licensed BT16 from the Hebrew University in Jerusalem and sublicensed the rights in Japan and certain Far East countries to the Japanese pharmaceutical company, Sanwa (a wholly owned subsidiary of the largest pharmaceutical wholesaler in Japan, Suzuken Co. Ltd.). Following our agreement with Sanwa, we returned the rights to BT16 to the university except the rights granted to Sanwa. Based on a large number of studies in different animal models and human studies, BT16 clearly reduced triglycerides, increased HDL-c and showed evidence of improving insulin resistance. A Phase I and two pilot IIA studies have been conducted in man. The Phase I study focused on PK/tolerance of BT16 in healthy volunteers while the two pilot IIA studies focused on patients with metabolic syndrome. All studies have shown that BT16 is safe; it was well tolerated over the dosing period (up to 22 weeks) at all doses (up to 800mg/d) with no drug-related adverse effects reported. Clinical activity results from these studies indicate that BT-16 caused a significant reduction in triglycerides and a reduction in cholesterol, demonstrating that BT16 may be active in treating dyslipidemia patients. Improvement in glucose clearance and insulin sensitization was shown, measured by intravenous glucose and insulin tolerance tests in patients with insulin resistance. Although the activity profile of BT16 appears to encompass several indications that fall under the “metabolic syndrome” (i.e., various aspects of disturbed lipid profile, insulin resistance), treatment of dyslipidemia (specifically hypertriglyceridemia) is the most outstanding activity based on the studies performed so far. Sanwa has the responsibility of performing the clinical studies in Japan.
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