US-based REMD Biotherapeutics has started enrolling patients in its Phase II trial of REMD-477 to treat type 2 diabetes.
REMD-477 is a fully human antibody that blocks glucagon receptor functions.
In September, the company secured approval from the US Food and Drug Administration (FDA) to start the Phase II clinical trial, which will be undertaken alongside its Beijing-based subsidiary Cosci-REMD Biotherapeutics (Cosci-REMD Bio).
About 72 patients with type 2 diabetes in San Diego, Miami and San Antonio will be enrolled in the trial.
It is designed to evaluate the safety and tolerability of REMD-477 following single and repeated doses in 72 patients.
The two-part trial will also evaluate changes in glucose, HbA1c, and insulin levels.
The first part will involve dose escalation of REMD-477, while the second part willl see changing dosing frequencies at specific doses.
REMD Bio and Cosci-REMD Bio president, co-founder and CEO Hai Yan said: "The initiation of this clinical study is another important milestone for REMD Bio and Cosci-REMD Bio."
Glucagon is a hormone that stimulates the liver and kidneys to produce glucose. It works with insulin to maintain glucose levels in humans.
The company noted that in several rodent models of type 2 diabetes, REMD-477 significantly suppressed glucagon receptor signaling, corrected hyperglycemia, and normalised glucose tolerance profiles.
US firm Amgen has originally developed REMD-477, and was licensed to REMD Bio in May 2013.
In a Phase I trial conducted by Amgen in healthy volunteers, a single injection of REMD-477 (then known as AMG477) reduced fasting glucose levels by 10-15% for up to four weeks.
University of Texas Southwestern Medical Center Diabetes Research professor and touchstone/west distinguished chair and REMD Bio scientific advisor Roger Unger said: "The promising preclinical data combined with available Phase I data from healthy volunteers using REMD-477 opens up a brand new therapeutic chapter in the field of diabetes mellitus."
Source: Press Release
REMD Biotherapeutics Phase 2 Clinical Study of REMD-477 for Patients with Type 2 Diabetes Now Enrolling
REMD-477 — an Antibody to the Glucagon Receptor — Represents Potential New Treatment for Diabetes
November 19, 2015 11:00 AM Eastern Standard Time
CAMARILLO, Calif.–(BUSINESS WIRE)–REMD Biotherapeutics, Inc. ("REMD Bio"), together with its subsidiary, Beijing-based Cosci-REMD Biotherapeutics ("Cosci-REMD Bio"), today announced that its phase 2 clinical study of REMD-477 is currently enrolling patients with type 2 diabetes. 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 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"
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.
For more information about the phase 2 clinical study of REMD-477 in type 2 diabetes, including criteria for participating and enrolling centers, please visit www.clinicaltrials.gov.
According to the Centers for Disease Control and Prevention more than 29 million people in the United States have diabetes. Type 2 is the most common type; approximately 90 percent of adults diagnosed have type 2 diabetes. Diabetes is a chronic disease caused by an imbalance of insulin and glucagon that results in high levels of blood glucose.
About REMD Biotherapeutics
REMD Biotherapeutics is a privately held, clinical-stage biotechnology company focused on creating and developing innovative protein-based therapies to treat metabolic diseases and other serious illnesses. The Company was founded by two former Amgen research scientists and has facilities in Camarillo, California and Beijing China (Cosci-REMD Biotherapeutics). Our lead product candidate, REMD-477 — a fully human antibody to the glucagon receptor — is presently in clinical studies for treatment of diabetes as well as in preclinical studies for treatment of other metabolic disorders. Our discovery research leverages our extensive expertise in generating and developing therapeutic antibodies to G protein-coupled receptors (GPCRs) as well as to other multi-transmembrane cell surface antigens.