BERKELEY, CALIFORNIA – (BUSINESS WIRE) – Carmot Therapeutics, Inc. (Berkeley, CA), a clinical-stage biotechnology company that uses its proprietary Chemotype Evolution (CE) technology to discover and develop disease-modifying therapies for metabolic diseases and cancer, announced today the US-American company Food and Drug Administration announced (FDA) to approve IND application for CT-868, Carmot’s dual GLP-1 and GIP receptor modulator.
With the IND, Carmot can initiate a randomized, double-blind, placebo-controlled, multicenter Phase 2 study to evaluate the efficacy, safety and tolerability of CT-868 over 26 weeks in overweight and obese patients with type 2 diabetes. Further studies to investigate the mechanism of action of CT-868 in non-diabetic insulin-resistant persons and in diabetics are also planned as part of this IND. Both studies are scheduled to begin in the second half of 2021.
“The treatment of type 2 diabetes and related metabolic diseases is currently undergoing a transformative change with the emergence of double activators of the GLP-1 and GIP incretin pathways. Through deep insights into the incretin function, Carmot has developed double modulators with an improved therapeutic index. CT-868, the first drug candidate to emerge from these efforts, has the potential to provide world-class weight loss to patients with type 2 diabetes and help reverse the disease, “said Dr. med. Manu Chakravarthy, Chief Medical Officer and Head of Research and Development at Carmot. “In the Phase 1 study, CT-868 demonstrated convincing pharmacodynamic activity across multiple clinical measures in overweight and obese healthy individuals, as well as a safe and generally well-tolerated profile. We are now expanding these observations in overweight and obese patients with type 2 diabetes to demonstrate the effects of CT-868 on glycemic control, weight loss, and tolerability. ”
About CT-868
CT-868 is a dual GLP-1 and GIP receptor modulator with a unique pharmacological profile that is optimized for improved tolerability at the GLP-1 receptor. The combined effects of GLP-1 and GIP result in greater body weight loss and greater glucose control. CT-868 is administered once daily to maximize efficacy and tolerability.
About obesity and type 2 diabetes. Obesity is 80-85% of the risk of developing type 2 diabetes, and obese people are up to 80 times more likely to develop type 2 diabetes than people with a BMI of less than 22 kg / m2. More than 2 in 5 adults (42%) are obese and nearly 3 in 4 adults (74%) are overweight in the United States, with adult obesity accounting for nearly $ 173 billion in annual medical expenses. By 2030, nearly one in two adults in the US will be obese. This increase is projected to result in more than a million additional cases of type 2 diabetes, heart disease and cancer annually. Another major driver of the pathogenesis of type 2 diabetes is insulin resistance, the inability of the body to adequately respond to insulin and carry out its effects. Carmot is developing a portfolio of therapeutics that target these causes (obesity and insulin resistance) for lasting benefits and improving patients’ quality of life.
About Carmot Therapeutics, Inc. Carmot Therapeutics (“Carmot”) is focused on the discovery and development of transformative therapies for patients with severe unmet medical needs in metabolic diseases and cancer. Carmot applies Chemotype Evolution (CE), a pioneering drug discovery technology, combined with unique biological expertise to identify innovative and superior therapeutics. In metabolic diseases, Carmot combines CE with new insights into incretin receptor signaling to develop a broad, valuable pipeline of peptide-based and small-molecule therapeutics. Carmot’s GLP-1 / GIP dual receptor modulator has entered phase 2 development and has the potential to be the best in a new class of treatments for type 2 diabetes and related indications. In addition, Carmot uses CE to identify novel covalent inhibitors and develop new therapeutics that target key oncogenic signaling pathways internally and in collaboration with partners. Carmot has successfully used CE with strategic partners, including the discovery collaboration with Amgen that resulted in LUMAKRASTM (sotorasib), the first KRAS inhibitor to hit the clinic and move on to FDA review of the new drug use.
