Islet Sciences, BHV Announce Publication of Phase 2b Clinical Studies of Remogliflozin Etabonate

RALEIGH, N.C. -- Islet Sciences, Inc. (OTCQB: ISLT) ("Islet Sciences"), a biopharmaceutical company developing new medicines and technologies for the treatment of metabolic disease, announced today the publication of two peer-reviewed articles highlighting clinical results from completed 12-week Phase 2b studies of remogliflozin etabonate ("remogliflozin"), a selective sodium glucose transporter 2 (SGLT2) inhibitor currently being developed by Brighthaven Ventures, L.L.C. ("BHV") for type 2 diabetes and nonalcoholic steatohepatitis (NASH).

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As previously announced, Islet Sciences and BHV have entered into a merger agreement that will combine the operations and development pipelines of the two companies. Upon closing of the transactions contemplated by the merger agreement, which require approval of Islet Sciences' stockholders, Islet Sciences and BHV will each become wholly owned subsidiaries of Avogenx, Inc. ("Avogenx"), which will operate under the leadership of the current Islet Sciences management.

The publications are available online with a subscription and are expected to appear in print in the scientific journal Diabetes, Obesity, and Metabolism early next year 1,2. Importantly, these clinical results collectively represent the foundation for developing a unique biphasic release formulation for remogliflozin, for which BHV expects to initiate a multi-center phase 2b study in the fourth quarter of 2014.

The phase 2b studies, which were highlighted recently at the 74th American Diabetes Association Annual Scientific Sessions conference in June 2014, demonstrated potential best-in-class safety and efficacy profiles, when dosed once- or twice-daily, respectively. These findings suggest that BHV's novel biphasic release formulation will allow remogliflozin to be dosed just once daily, while maintaining the significant HbA1c lowering and weight loss observed with twice-daily dosing. Additionally, the findings suggest this formulation will maintain the low incidence of urogenital infections and lack of increase of LDL-c observed with a single daily dose of remogliflozin.

Islet Sciences and BHV also recently announced that BHV entered into an exclusive licensing agreement with Libbs Farmaceutica ("Libbs"), a leading Brazilian pharmaceutical company, for the exclusive rights to develop and commercialize remogliflozin in select territories in Latin America. Pursuant to the licensing agreement, Libbs agreed to make an initial payment of $1.5 million. In addition, Libbs agreed to a royalty and profit-share mechanism upon commercialization in the licensed territories, Libbs has also agreed to fund a substantial portion of BHV's planned U.S. phase 2b study of remogliflozin for the treatment of type 2 diabetes.

William Wilkison, Ph.D., Islet Sciences' Chief Operating Officer, stated, "We believe publication of these key studies provides additional validation for our clinical work with remogliflozin, and together they articulate the genesis for creating the novel biphasic formulation. With the added support from BHV's licensing partner Libbs, BHV plans to advance to the next step in the phase 2b development program for remogliflozin, which Islet Sciences and BHV believe will demonstrate its highly differentiated profile and best-in-class potential for treating type 2 diabetes and NASH."

About Islet Sciences
Islet Sciences, Inc., a biopharmaceutical company based in Raleigh, NC, is developing new medicines and technologies for the treatment of metabolic disease. On September 30, 2014, Islet Sciences and BHV entered into a definitive merger agreement. Following closing, the combined organization will operate under the name Avogenx, Inc., with a combined pipeline that will include remogliflozin etabonate for the treatment of type 2 diabetes and NASH, a cell-based transplantation therapy for insulin-dependent diabetes; immune-modulating small molecule IL-12 antagonists targeting beta-cell preservation, and a PCR-based molecular diagnostic measuring beta-cell loss for the diagnosis of type 1 diabetes or onset of insulin-dependent type 2 diabetes. For more information, please visit

About BHV
BHV, a privately held pharmaceutical company based in Research Triangle Park, NC, is developing the SGLT2 inhibitor remogliflozin etabonate for type 2 diabetes and NASH.