Cadila Healthcare Ltd has filed an investigational new drug (IND) application for its new molecular entity ZYO1, which the Indian drug maker says is a novel drug candidate for treating obesity and related disorders with the DCGI.
According to Cadila, ZYO1 is a novel experimental drug working through CB-1 mechanism, to help obese patients lose weight, and also help in controlling blood sugar levels in type2 diabetes. The drug could also have a role in protecting the heart.
It says its recently concluded pre-clinical studies on ZYO1 have reported interesting and encouraging findings which indicate a novel molecule with superior pre-clinical profile and remarkably better safety profile. "The only other drug that has gained approval in the CB-1 class, says Cadila, is Rimonabant, and since its approval, the diet drug has been clouded in controversy due to side effects like nausea, vomiting and an increase in psychiatric liabilities," says a communiqué from the company in a release to the stock exchanges. Incidentally, Rimonabant is manufactured by Sanofi-Aventis.
Diabetes and obesity are chronic conditions requiring continuous treatment over an extended period of time and therefore a drug with greater safety margins, could be the ideal solution for controlling chronic conditions like obesity, diabetes and cardiovascular risks.
According to Pankaj Patel, chairman and managing director, Zydus Cadila, "With ZYH1 undergoing phase II trials, ZY11 ready for phase II trials and ZYH2 undergoing phase I trial, we are building up an promising pipeline of new molecular entities. ZYO1, the fourth NCE in the pipeline, has show remarkable efficacy and clean toxicity profile in pre-clinical trials. It holds promising commercial potential as a future blockbuster due to unmet medical needs and absence of effective treatments for obesity and related disorders." Cadila plans to initiate phase I clinical trials to ensure the safety and tolerability of ZYO1. Once the safety of the drug is established it plans to develop it further to treat various cardio-metabolic risk factors in patients with obesity and prove its beneficial effects in improving HbA1c, HDL-cholesterol, triglycerides, systolic blood pressure and reducing waist circumference.