Avolynt, Inc. Announces First Marketing Authorization and Commercial Launch of Novel SGLT2 Inhibitor Remogliflozin Etabonate for Type 2 Diabetes

RESEARCH TRIANGLE PARK, NC / ACCESSWIRE / May 2, 2019 / Avolynt, Inc., a company focused on the development of novel therapeutics for rare and metabolic diseases, announced today receipt of marketing authorization from the Drug Controller General of India and commercial launch of novel SGLT2 inhibitor remogliflozin etabonate (“Remogliflozin”) by Avolynt collaborator Glenmark Pharmaceuticals (“Glenmark” Mumbai, India).

In 2016, Avolynt subsidiary Brighthaven Ventures, LLC, d/b/a BHV Pharma, licensed certain rights for Remogliflozin to Glenmark. Avolynt and Glenmark completed a phase 3 clinical trial of remogliflozin in subjects with type 2 diabetes. The study met all of its endpoints and remogliflozin was demonstrated to be safe and efficacious in a head-to-head comparison against Dapagliflozin.

SGLT2 inhibitors are a unique class of insulin-independent oral anti-diabetic agents that help promote glycemic control by blocking the SGLT2 transporters in the proximal tubule of the kidney, thereby preventing renal reabsorption of glucose and promoting excretion of glucose in the urine. SGLT2 inhibitors have been shown to promote glycemic control, induce weight loss, improve renal function and reduce cardiovascular risks.

“Globally, SGLT2 inhibitors are emerging as a preferred treatment for management of type-2 diabetes and Glenmark is proud to introduce an innovative molecule in this class, which is cutting-edge and researched extensively. Diabetes is a key area of focus for Glenmark and with the launch of Remogliflozin, the company aims to increase the patient pool in the SGLT2 category by providing a more effective, high quality and world-class treatment option,” said Sujesh Vasudevan, President, India Formulations, Middle East and Africa at Glenmark Pharmaceuticals.

“We are delighted to be collaborating with Glenmark and this successful approval and launch represents another milestone in our continuing effort to develop innovative therapeutics to improve the lives of patients suffering from diabetes mellitus and other forms of metabolic disease,” said James Green, Chief Executive Officer at Avolynt.

About Remogliflozin Etabonate

Remogliflozin is a selective SGLT2 inhibitor and potent anti-oxidant in development for nonalcoholic fatty liver disease (“NAFLD”) / nonalcoholic steatohepatitis (“NASH”) and type 2 diabetes. Remogliflozin has been dosed in over 1,500 subjects in 26 clinical trials where it demonstrated significant improvements in HbA1c, insulin sensitivity, beta cell function and weight. Additionally, remogliflozin has demonstrated significant improvement in liver enzymes, oxidative stress and inflammation, parameters closely associated with NAFLD/NASH.

About Avolynt, Inc.

Avolynt is a privately-owned drug development company based in Research Triangle Park, North Carolina. Avolynt’s mission is to develop novel therapeutics that improve the lives of patients suffering from dysfunctions related to human metabolism. The Avolynt team has significant discovery and development experience across the metabolic syndrome, including diabetes, obesity, nonalcoholic steatohepatitis (NASH) and other metabolic diseases. For more information about Avolynt, visit https://www.avolynt.com/.

About Glenmark Pharmaceuticals Ltd.

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization. It is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2018). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is focused in the areas of oncology, dermatology and respiratory. Glenmark has six R&D centers and 16 manufacturing facilities across five countries. For more information about Glenmark, visit http://www.glenmarkpharma.com.

+1 (919) 659-5677 info@avolynt.com

SOURCE: Avolynt, Inc.

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