BHV Pharma Announces Completion of Clinical Study of SGLT2 Inhibitor Remogliflozin Etabonate

Dec. 27, 2011 - PRLog -- Clinical Study of SGLT2 Inhibitor Remogliflozin Etabonate Demonstrates Effectiveness of Novel Once-Daily Formulation

RESEARCH TRIANGLE PARK, N.C. (December 27, 2011) BHV Pharma, a clinical-stage drug development company, announced today positive results from a recent clinical study of Remogliflozin Etabonate, a novel Sodium Glucose Transporter 2 (SGLT2) inhibitor. These clinical results demonstrate the effectiveness of a once-daily formulation with an improved pharmacokinetic profile and increased urinary glucose excretion over the formulation previously studied in Phase IIb trials in type II diabetics.
 
SGLT2 inhibitors are an important emerging class of compounds that will be the only orally available treatment for type 2 diabetics providing significant HbA1c lowering with clinically relevant weight loss. More importantly, SGLT2 inhibition provides patients this benefit through an insulin independent, beta-cell sparing mechanism.  Remogliflozin etabonate is an O-linked glycoside, highly selective inhibitor of SGLT2.

Pharmacokinetic data from the study show that single doses of the formulation achieved enhanced blood concentrations during the day with reduced exposure at night across all cohorts. Urinary glucose excretion was proportionally greater for each dose in this study compared to the previously studied formulation. The drug was well-tolerated with few adverse events.  The results of this study will be used to determine an appropriate dose range for an upcoming Phase IIb trial.  

“The biology associated with SGLT2 inhibition naturally lends itself well to managing blood glucose on a postprandial basis. But SGLT2 inhibition in a fasting or overnight state may contribute significantly to adverse events typically thought to be a class effect,” said William Wilkison, BHV Chief Scientific Officer.  According to Wilkison, “By optimizing Remogliflozin blood concentrations during the day and reducing exposure at night we expect to see superior HbA1c lowering and weight loss with a cleaner tolerability profile, particularly around urogenital issues common with SGLT2 inhibitors, and also without the concerns associated with less selective compounds in development.”

About the Pharmacokinetic study

This clinical study assessed the pharmacokinetics, pharmacodynamics, and safety of single doses of Remogliflozin Etabonate in 12 healthy subjects. The primary objective of the trial was to establish the PK profile of the different doses in relation to the pharmacodynamics effect of urinary glucose excretion. The study was conducted in the U.S and managed by Integrium Clinical Research.

About Remogliflozin Etabonate

Remogliflozin is a new chemical entity (NCE) that selectively inhibits the sodium glucose transporter 2.  This compound has been assessed for efficacy, tolerability and safety in multiple clinical trials, including two Phase IIb studies in type II diabetics.  Other studies that have been completed in the development of this compound include standard toxicology, pharmacology, safety and food and drug interaction studies. Remogliflozin etabonate was discovered by Kissei Pharmaceuticals Co., Ltd. and licensed to BHV Pharma.

About BHV Pharma

BHV, a Research Triangle Park-based clinical-stage drug development company, is focused on developing therapeutics for the treatment of metabolic diseases such as diabetes and obesity.  http://www.bhvpharma.com

About Kissei Pharmaceuticals

Kissei Pharmaceutical Co., Ltd. was founded in 1946 and has grown into one of Japan's leading pharmaceutical companies. Kissei's management vision is to be an R&D-oriented pharmaceutical company that contributes to the health of people around the world through developing and commercializing innovative drugs. Kissei is actively pursuing collaborations with many companies to strengthen its R&D pipeline, and also promoting global expansion by licensing out original agents as an important management strategy.  For more information on Kissei, please see the international website.  http://www.kissei.co.jp/

About Integrium LLC

Integrium, a contract research organization (CRO) with special expertise in cardiovascular and metabolic therapeutics, rapidly enrolled healthy volunteers and conducted the Phase I clinical trial. IntegriumQT is a rapid Phase 1 program that speeds drugs, diagnostics and devices from the bench to the clinic. Integrium has a dedicated cardiovascular core lab team and a fully equipped Phase I/PK unit. http://www.integrium.com/

Investor Inquiries:
BHV Pharma
James Green
919.904.4248
james@bhvpharma.com