CohBar Completes Phase 1a and Initiates Phase 1b Stage of Clinical Trial of CB4211 Under Development for NASH and Obesity
Posted on November 05, 2019 by Medtech[y] Staff
CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases and extend healthy lifespan, today announced the completion of the Phase 1a stage of the company’s ongoing Phase 1a/1b study evaluating the safety, tolerability, and activity of CB4211, and the initiation of recruitment for the Phase 1b stage. CB4211 is under development as a potential treatment for nonalcoholic steatohepatitis (NASH) and obesity, and is the first therapeutic candidate based on a mitochondrial-derived peptide to enter clinical testing.
“The completed Phase 1a stage of the CB4211 clinical study evaluated safety and tolerability after seven days of dosing, and the drug was safe and well tolerated under the amended protocol,” said Ken Cundy, Ph.D., Chief Scientific Officer. “Advancing to the next stage of the study in obese patients with non-alcoholic fatty liver diseases, or NAFLD, is an important milestone for CohBar. In preclinical studies, CB4211 demonstrated significant improvement in the NAFLD activity score in a NASH model and reduction of liver fat and body weight in obese animals. The Phase 1b stage of the study is designed to explore those effects in humans. We look forward to demonstrating the clinical utility of CB4211.”
The Phase 1b stage of the ongoing study is designed to assess the safety, tolerability, and activity of CB4211 in obese subjects with NAFLD. The double-blind, placebo-controlled evaluation will be conducted over four weeks in twenty patients with ten patients receiving CB4211 and ten receiving placebo. Assessments will include changes in liver fat as determined by MRI-PDFF, body weight, and biomarkers relevant to NASH and obesity. Results from both stages of the study are anticipated in mid-2020.
An estimated 75 million U.S. adults have NAFLD, and as many as 35% of them, or 26 million, will progress to NASH. Approximately 20% of people with NASH will go on to develop fibrosis (scarring) of the liver, leading to cirrhosis and an increased risk of liver failure and cancer. There are no approved treatments for the disease.
About CB4211 CohBar’s lead clinical program is based on CB4211, a first-in-class mitochondria based therapeutic, that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide, which has been shown to play a significant role in the regulation of metabolism, and was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators. NASH is a chronic and silent disease in its early stages that can progress to more serious disease stages, such as advanced fibrosis, cirrhosis, liver failure or liver cancer. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is no approved treatment for the disease.
About CohBar CohBar (NASDAQ: CWBR) is a clinical stage biotechnology company focused on the research and development of mitochondria based therapeutics, an emerging class of drugs for the treatment of chronic and age-related diseases. Mitochondria based therapeutics originate from the discovery by CohBar’s founders of a novel group of naturally occurring mitochondrial-derived peptides within the mitochondrial genome which regulate metabolism and cell death, and whose biological activity declines with age. CohBar’s efforts focus on the development of these peptides into therapeutics that offer the potential to address a broad range of age-related diseases, including nonalcoholic steatohepatitis (NASH), obesity, type 2 diabetes, fibrotic diseases, cancer, and cardiovascular and neurodegenerative diseases. The company’s lead compound, CB4211, is in a Phase 1a/1b clinical trial that includes an evaluation of biological activity relevant to NASH and obesity. To date, the company and its founders have discovered more than 100 mitochondrial-derived peptides. For additional company information, please visit www.cohbar.com.