REMD BIOTHERAPEUTICS RECIEVES INVESTIGATIONAL NEW DRUG (IND) APPROVAL FOR REMD-477

Camarillo, CA - REMD Biotherapeutics is pleased to announce that the FDA has granted Investigational New Drug (IND) status to REMD-477, their flagship drug for diabetes mellitus. The monoclonal antibody specifically targets and blocks the glucagon receptor, corrects hyperglycemia by reducing hepatic glucose output, and represents a promising new class of antidiabetic therapeutics with no risk of hypoglycemia. This drug will greatly alter the course of diabetes treatment and improve the quality of life for an ever-growing patient population.

REMD-477’s long journey
Originally one of Amgen’s shelved projects, AMG-477 found new life when REMD in-licensed the drug on May 13, 2013. It was subsequently renamed REMD-477 and the REMD team continued research where Amgen had left off. REMD-477 was once placed on a full clinical hold when an initial Amgen study found pancreatic fibrosis in some older male rats. The REMD team successfully convinced the FDA that this observation was not causally related to REMD-477. On October 20, 2013, the FDA lifted the hold, agreeing that “the pancreatic fibrotic lesions…are spontaneous, age-related lesions,” and thus were not a clinical safety concern. 

REMD’s ensuing findings were so meaningful, that they published their first paper on Type 1 Diabetes Mellitus in the Proceedings of the National Academy of Sciences (PNAS) on February 24, 2015. The paper showed significant evidence of hyperglycemia correction, several metabolic marker improvements, and restoration of normal HbA1c levels, after treatment using REMD-477 or its analogues in a number of type 1 diabetic models in mice. Clinical trials have already begun in type II diabetic patients at three sites in California, Texas, and Florida.

A well-deserved celebration
To commemorate this pivotal achievement, REMD hosted a dinner party on September 23, 2015 for employees, consultants, collaborators, friends, and family at the Westlake Village Inn in Thousand Oaks, California,. Hai Yan, President and CEO, expressed his gratitude saying: “we have worked tirelessly to reach this milestone and could not have accomplished this feat without [everyone’s] support.” Keynote speakers included VP of Clinical Development - Jim Shi, Chief Scientific Officer - Tom Boone, and Director of Quality & Regulatory Affairs - Jan Fang.  

Around 90 guests enjoyed a Pan-Asian & American dinner and a prize raffle for dinnerware sets & bottles of wine. REMD was also proud to hand out “This is my first REMD T-shirt!” shirts to all guests.