Zydus Cadila has filed IND (Investigational New Drug) application for the New Molecular Entity (NME) - ZYO1, a novel drug candidate for treating obesity and related disorders with the DCGI.
ZYO1 is a novel experimental drug working through CB-1 mechanism, which will help obese patients lose weight, and also help in controlling blood sugar levels in type-2 diabetes. The drug could also have a role in protecting the heart.
The recently concluded pre-clinical studies on ZYO1 have reported interesting and encouraging findings which indicate a novel molecule with superior preclinical profile and remarkably better safety profile. The only other drug that has gained approval in the CB-1 class is Rimonabant, and since its approval, the diet drug has been clouded with controversy due to its side effects like nausea, vomiting and an increase in psychiatric liabilities, company release stated.
Diabetes and obesity are chronic conditions requiring continuous treatment over an extended period of time and therefore a drug having greater safety margins, like ZYO1, could be the ideal solution for controlling chronic conditions like obesity, diabetes and cardiovascular risks.
Speaking on the new development, Pankaj Patel, chairman and managing director, Zydus Cadila said, "This is an important milestone in the new drug discovery initiatives that are being undertaken at the Zydus research centre. With ZYH1 undergoing phase II trials. ZYI1 ready for phase II trials and ZYH2 undergoing phase I trials, we are building up a promising pipeline of new molecular entities. ZYO1, the fourth NCE in the pipeline, has shown remarkable efficacy and clean toxicity profile in preclinical 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."
The World Health Organisation describes obesity as "one of the greatest public health challenges of the 21st century". It is also a major risk factor for type-II diabetes and cardiovascular disease. According to a WHO estimate, more than one billion people worldwide are over-weight of which at least 300 million are clinically obese.
Zydus Cadila plans to initiate phase I clinical trials to ensure the safety and tolerability of ZYO1. Once the safety of the drug is established the company 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.