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news.REMD Biotherapeutics, together with its subsidiary, Beijing-based Cosci-REMD Biotherapeutics, announced that its phase 2 clinical study of REMD-477 is currently enrolling patients with type 2 diabetes.
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The Company received approval from the U.S. Food and Drug Administration (FDA) of its investigational new drug (IND) application to begin the phase 2 clinical study in September.
The study is a randomized, placebo-controlled, double-blind, dose escalation study to evaluate the safety and tolerability following single and repeated doses of REMD-477 in approximately 72 patients with type 2 diabetes. Changes in glucose, HbA1c, and insulin levels will also be measured.
The study has a two-part design: the first part for dose escalation of REMD-477 and the second part for dosing frequency at specific doses determined in the first part of the study. The study is recruiting patients in San Diego, Miami, and San Antonio.
"The initiation of this clinical study is another important milestone for REMD Bio and Cosci-REMD Bio. We are pleased with the quick response from FDA, who reviewed and approved our IND in a month," stated Hai Yan, Ph.D., President, co-founder, and CEO of the Companies.
Glucagon is a hormone that stimulates the liver and kidneys to produce glucose. It works in concert with insulin to maintain glucose levels in humans.
Elevated glucagon levels have been found in every form of diabetes. Attenuating glucagon action by blocking the glucagon receptor will likely reduce endogenous glucose production, lower glucose levels, and improve diabetes control. REMD-477 is a fully human antibody that specifically binds to and blocks the glucagon receptor functions.
In several rodent models of type 2 diabetes, REMD-477 significantly suppressed glucagon receptor signaling, corrected hyperglycemia, and normalized glucose tolerance profiles.
REMD-477 was originally developed at Amgen and was licensed to REMD Bio in May 2013. In the phase 1 clinical study conducted by Amgen in healthy volunteers, a single injection of REMD-477 (then known as AMG477) reduced fasting glucose levels by 10 to 15 percent for up to four weeks.
"The promising preclinical data combined with available phase 1 data from healthy volunteers using REMD-477 opens up a brand new therapeutic chapter in the field of diabetes mellitus," said Roger Unger, M.D., Professor and Touchstone/West Distinguished Chair in Diabetes Research at University of Texas Southwestern Medical Center, and a scientific advisor to REMD Bio.