BERKELEY, California – (BUSINESS WIRE) – Carmot Therapeutics, Inc. (Berkeley, CA), a clinical biotechnology company that applies its patented Chemotype Evolution (CE) technology to discover and develop metabolic disease and cancer-modifying therapies, the US Food and Drug Administration announced today. (FDA) release of an IND order for CT-868, Carmot’s double GLP-1 and GIP receiver modulator.
IND will allow Carmot to initiate a randomized, double-blind, placebo-controlled Phase 2 multicenter study to assess the efficacy, safety and tolerability of CT-868 over 26 weeks in overweight and obese patients with type 2 diabetes Additional studies to investigate the mechanism of action of CT-868 in insulin-resistant non-diabetic individuals and in diabetics are also planned under this IND. Both studies are planned to start in the second half of 2021.
“The treatment of type 2 diabetes and associated metabolic diseases is currently undergoing a transformative change with the advent of dual activators of the GLP-1 and GIP incretin pathways. Through deep insights into incretin function, Carmot has developed dual modulators with an improved therapeutic index. CT-868, the first drug candidate to emerge from these efforts, has the potential to provide best-in-class weight loss for patients with type 2 diabetes and help reverse the course of the disease, ”said Manu Chakravarthy, MD, PhD, Medical Director and Head of R&D at Carmot. “In the Phase 1 trial, CT-868 demonstrated attractive pharmacodynamic activity in several clinical measures in healthy overweight and obese individuals, along with 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. ”
CT-868 is a dual modulator of the GLP-1 and GIP receptor with a unique pharmacological profile optimized for better tolerability at the GLP-1 receptor. The combined action of GLP-1 and GIP results in greater loss of body weight and glucose control. CT-868 is administered once daily to maximize efficacy and tolerability.
About obesity and type 2 diabetes. Obesity is responsible for 80-85% of the risk of developing type 2 diabetes, and obese individuals are up to 80 times more likely to develop type 2 diabetes than those with a BMI below 22 kg / mtwo. More than 2 out of 5 adults (42%) are obese and nearly 3 out of 4 adults (74%) are overweight in the United States, with obesity in adulthood accounting for nearly $ 173 billion in annual medical expenses . By 2030, almost 1 in 2 adults in the United States will be obese. Annually, this increase is expected to result in more than one million extra cases of type 2 diabetes, heart disease and cancer. Another important factor in the pathogenesis of type 2 diabetes is insulin resistance, the body’s inability to respond adequately to insulin and perform its actions. Carmot is developing a portfolio of therapies that target these basic causes (obesity and insulin resistance) to provide lasting benefits and improve patients’ quality of life.
About Carmot Therapeutics, Inc. Carmot Therapeutics (“Carmot”) is focused on the discovery and development of transformative therapies for patients with serious unmet medical needs in metabolic diseases and cancer. Carmot applies Chemotype Evolution (CE), a pioneering technology in drug discovery, in combination with exclusive biological experience to identify innovative and superior therapies. In metabolic diseases, Carmot is combining EC with new insights into incretin receptor signaling to develop a broad and valuable line of peptide and small molecule-based therapy. Carmot’s dual GLP-1 / GIP 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 is using the EC to identify new covalent inhibitors and to develop new therapies targeting the main oncogenic pathways, internally and with partners. Carmot successfully applied CE with strategic partners, including the discovery collaboration with Amgen that led to LUMAKRASTM (sotorasib), the first KRAS inhibitor to enter the clinic and proceed to the FDA’s review of the new drug application.