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Carmot Therapeutics Highlights Clinical Data from its Pipeline of Treatments for Obesity and Diabetes at ObesityWeek®
DALLAS, Oct. 15, 2023 (GLOBE NEWSWIRE) -- Carmot Therapeutics Inc. (Carmot), a clinical-stage biotechnology company dedicated to developing life-changing therapeutics for people with metabolic diseases, today announced positive results from the following studies: a study of CT-388 to evaluate the safety/tolerability, efficacy, and pharmacokinetics of CT-388 in people with overweight/obesity without type 2 diabetes (T2D), a study of CT-868 assessing the efficacy and safety of CT-868 in overweight/obese patients with T2D, and a preclinical mechanism of action (MOA) study to investigate the impact of a unimolecular dual biased GLP-1/GIP receptor agonist (RA) in regulating weight loss and food intake. The results are summarized in three poster presentations taking place at ObesityWeek October 14-17, 2023. “Overall, we are very pleased with the results emerging from our CT-388 and CT-868 programs. Given the association of obesity and insulin resistance and risk for T2D, results from the CT-388 study showing clinically meaningful weight loss with improved glucose homeostasis and insulin sensitivity have significant implications for the potential of CT-388 as a disease-modifying therapeutic for both obesity and type 2 diabetes,” said Manu Chakravarthy, MD, PhD, Carmot’s Chief Scientific & Medical Officer. “Additionally, with CT-868, to see such a dramatic improvement in glycemic control from this Phase 2 study coupled with our prior results demonstrating the potential for GIP-mediated insulin independent glucose disposal provides robust clinical and mechanistic support for CT-868 as an effective adjunctive treatment for patients living with type 1 diabetes.” Dr. Chakravarthy added, “Data from the CT-859, the mouse analog of CT-868, rodent experiments highlight the actions of a fully biased dual GLP-1 and GIP receptor agonist in the central nervous system to induce sustained food intake suppression and weight loss. We’re looking forward to evaluating the implications of these results for CT-868 in humans.” Summaries of the three presentations are as follows: In a Phase 1 placebo-controlled, double-blind, multicenter clinical trial, 24 participants were randomized 3:1 (6 to CT-388, 2 to placebo) to evaluate the safety/tolerability, efficacy, and pharmacokinetics of ascending doses of CT-388 in participants with overweight and obesity without T2D. An oral glucose tolerance test was performed on Day -1 (baseline) and Day 23 (post the 4th dose). The results were as follows: Overall, these data support further clinical evaluation of CT-388, with higher doses while maintaining and exploring simpler titration schemes, for the treatment of obesity, T2D and other weight-related comorbidities. Carmot has designed the ongoing Phase 1/2 CT-388 clinical trial to evaluate a higher starting dose, a higher maximum dose and simpler titration schemes. Carmot expects to initiate additional Phase 2 trials for obesity and T2D. In a Phase 2, 26-week, placebo-controlled, double-blind, multicenter clinical trial, 103 participants were randomized across 3 treatment groups (placebo, CT-868 1.75mg, and CT-868 4mg) to evaluate the efficacy and safety of CT-868 administered daily by subcutaneous injection in overweight/obese T2D participants suboptimally controlled with diet and exercise with and without metformin. The results were as follows: Overall, these data demonstrate a robust effect of CT-868 on glycemic control. In addition, results from our previous preclinical experiments and phase 1b studies in participants with T2D provide mechanistic support for CT-868’s potential impact on insulin independent glucose disposal. Together, these data provide strong rationale to pursue CT-868 as an adjunct to insulin for the treatment of T1D. Carmot is currently conducting a Phase 1b mechanism of action clinical trial in patients with T1D to assess glucose homeostasis, and expects to conduct a Phase 2 proof-of-concept clinical trial in patients with overweight/obesity with T1D. In this rodent study, CT-859 (the mouse analog of CT-868) was investigated to assess the impact of a centrally administered unimolecular dual GLP-1/GIP RA in regulating food intake (FI) and weight loss (WL). CT-859, a fully cAMP-biased dual GLP-1/GIP RA that exhibits no β-arrestin coupling at either receptor, was administered to GLP-1R knockout (KO) mice and wildtype (WT) mice by intracerebroventricular injection. The results from this study are as follows: All posters can be found on the . CT-388 is a once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist being developed for the treatment of obesity and type 2 diabetes (T2D). CT-388 was designed to have potent activity on both the GLP-1 and GIP receptors but with minimal to no ß-arrestin recruitment on either receptor. This biased signaling significantly minimizes receptor internalization and consequent desensitization, which Carmot believes leads to prolonged pharmacological activity. It is currently being studied in a multi-part, multi-cohort Phase 1/2 clinical trial in people with overweight/obesity with and without T2D. CT-868 is a once-daily subcutaneous injectable, dual GLP-1/GIP receptor agonist being developed as an adjunct to insulin for the treatment of people with type 1 diabetes (T1D) with overweight or obesity. CT-868 was designed to be potent on both GLP-1 and GIP receptors with no ß-arrestin recruitment to either receptor (i.e. fully biased). It is currently being studied in a Phase 1b mechanism of action clinical trial in people with T1D to assess glucose homeostasis. Carmot plans to conduct a Phase 2 proof-of-concept clinical trial in people with overweight or obesity with T1D. Carmot Therapeutics is a clinical-stage biotechnology company dedicated to developing life-changing therapeutics for people living with metabolic diseases, including obesity and diabetes. Carmot’s expertise in metabolic biology has enabled the development of a broad pipeline of therapeutics, including three clinical candidates: CT-388 (once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist), CT-868 (once-daily subcutaneous injectable, dual GLP-1/GIP receptor agonist) and CT-996 (once-daily oral, small molecule GLP-1 receptor agonist), and others in preclinical development. All of these are proprietary novel compounds, wholly-owned by Carmot, that have the potential to deliver an enhanced treatment response in people with metabolic diseases. For more information, visit the website and follow us on .
Publish Date : 2023-10-15 16:00:00
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