Chugai Pharmaceutical has concluded a licence agreement with F Hoffmann-La Roche for CT-388, a long-acting GLP-1/GIP receptor agonist, currently in development for obesity and type-II diabetes.

Under the licence agreement between Roche and Chugai, Chugai obtained exclusive rights for the development and marketing of CT-388 in Japan. Roche will receive an upfront fee and milestone payments.

Speaking in this regard, Dr Osamu Okuda, President and CEO, Chugai, “CT-388 selectively acts on both GLP-1 and GIP receptors. It is expected to provide sustained weight reduction and good glycaemic control, offering a potential new treatment option for patients with obesity or type-II diabetes. Chugai will work closely with Roche to advance the development of CT-388 to deliver it to patients in Japan as soon as possible.”

In the overseas phase-I clinical study (CT-388-101 trial) of CT-388, adults with obesity received weekly subcutaneous injections of CT-388 for 24 weeks, resulting in a placebo-adjusted mean weigh reduction of -18.8 percent (p<0.001) at week 24, demonstrating clinically meaningful and statistically significant weight reduction compared to placebo. In the CT-388 treatment group, 100 percent of participants achieved >5 percent weight reduction, 85 percent achieved >10 percent, 70 percent achieved >15 percent, and 45 percent achieved >20 percent weight reduction. The treatment was well-tolerated, with mostly mild to moderate gastro-intestinal side effects commonly observed with incretin-based therapies. CT-388 is currently in phase II clinical trials overseas for obesity with type-II diabetes.

Chugai will continue to effectively utilise the Research and Development (R&D) resources of the Roche Group to find innovative new drugs so as to satisfy unmet medical needs.

The CT-388-101 trial is a phase-I randomised, double-blind, placebo-controlled study in adult participants with overweight or obesity and in participants with obesity and type-II diabetes, evaluating CT-388 from low to high doses through single ascending doses, multiple ascending doses, and repeated dosing for up to 24 weeks. The trial enrolled 129 participants. The primary endpoint was the safety and tolerability of CT-388, with secondary endpoints including effects on weight and glucose homeostasis. The pharmacokinetics and other pharmacodynamic effects of CT-388 were also evaluated.

CT-388 is a GLP-1/GIP receptor agonist administered by weekly subcutaneous injection being developed for the treatment of obesity and type-II diabetes. It is designed to show high activity at both GLP-1 and GIP receptors while minimising ß-arrestin recruitment at either receptor. This biased signalling is expected to substantially reduce receptor internalisation and associated desensitisation, leading to sustained pharmacological effects.