4 May 2021 - - The US Food and Drug Administration clearance of an IND application for CT-868, US-based biotechnology company Carmot Therapeutics, Inc's dual GLP-1 and GIP receptor modulator, the company said.

The IND will enable Carmot to initiate a Phase 2 randomized, double-blind, placebo-controlled, multi-center trial to evaluate 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 non-diabetic insulin resistant individuals and in diabetics are also planned under this IND.

Both studies are planned to initiate in the second half of 2021.

CT-868 is a dual GLP-1 and GIP receptor modulator with a unique pharmacological profile optimized for improved tolerability at the GLP-1 receptor.

The combined action of GLP-1 and GIP result in greater body weight loss and glucose control. CT-868 is dosed once daily to maximize efficacy and tolerability.

Carmot is developing a portfolio of therapeutics that target these root causes (obesity and insulin resistance) to provide durable benefit and improve quality-of-life for patients.

Carmot applies Chemotype Evolution, a pioneering drug discovery technology, in combination with unique biological expertise to identify innovative and superior therapeutics.

In metabolic disease, Carmot is combining CE with novel insights into incretin receptor signaling to develop a broad, valuable pipeline of peptide-based and small molecule therapeutics.

Carmot's dual GLP-1/GIP receptor modulator has entered Phase 2 development and has the potential to be best in a new class of treatments for type 2 diabetes and related indications.

In addition, Carmot is using CE to identify novel covalent inhibitors and to develop new therapeutics targeting major oncogenic pathways, internally and with partners.

Carmot has successfully applied CE with strategic partners including the discovery collaboration with Amgen that led to Lumakras (sotorasib), the first KRAS inhibitor to enter the clinic and advance to FDA New Drug Application review.