Zydus' Novel Orally Administered GLP-1 Agonist - 'ZYOG1' to treat Diabetes and Obesity Enters Phase I Clinical Trial

Monday, June 21, 2010 Diabetes News
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AHMEDABAD, India, June 21, 2010 Zydus Cadila, a globalhealthcare provider and one of India's leading healthcare companies hasreceived Phase I clinical trial permission from the DCGI for ZYOG1 - a novelGLP-1 agonist. Designed and developed at the Zydus Research Centre using aunique platform technology, ZYOG1 is a novel, oral, anti-diabetic molecule.

The new class of anti-diabetic drugs called Glucagon Like Peptide-1 (GLP-1) agonists came to the fore in May 2005 when the first molecule of thisclass was approved by the USFDA. Glucagon Like Peptide-1 agonists are beingused to treat people with type 2 diabetes who have not been able to controltheir blood sugar levels with oral medicines. It is an injectible which actslike the natural hormones in the body that lowers blood sugar.

ZYOG1 would represent a next generation GLP-1 agents, as it would nothave to be injected but can be taken orally. ZYOG1, when administered by oralroute demonstrated beneficial effects in preclinical models on glucosereduction, HbA1c reduction and showed an added benefit of weight loss.Additionally, ZYOG1 has displayed a differentiated preclinical safety profilewith no nausea-like symptoms in the preclinical studies.

Speaking on the new development, Mr. Pankaj R. Patel, Chairman andManaging Director, Zydus Cadila, said, "The discovery of the novel oral GLP-1agonist, ZYOG1, using our own unique, discovery platform technology, is asignificant achievement for us. This novel molecule would address unmetmedical needs in treating diabetes and holds promising potential in theanti-diabetic and anti-obesity market."

The number of diabetics in the world, now estimated to be 246 million, isexpected to increase rapidly to 380 million in 2025. Currently, 41 million(16.6%) of the diabetic population live in India and the number of diabeticsare expected to touch 70 million (18.4%) in 2025. In 2025 nearly half of theworld's diabetic population will be from India, China, Brazil, Russia andTurkey. Research in the field of anti-diabetic therapy seeks to address theproblems of hypoglycemia, GI side effects, lactic acidosis, weight gain, CVrisks, edema, potential immunogenicity etc., which pose a major challenge inthe treatment of diabetes. The global anti-diabetic market was estimated at$24 bn in 2008.

ZYOG1 is the latest addition to the group's strong research pipeline ofNMEs in clinical development. The NME - ZYH1, for treating dyslipidemia isundergoing Phase III clinical trials. ZYI1, the anti-inflammatory and painmanagement compound is currently in Phase II clinical trials. ZYO1, a noveldrug candidate for treating obesity and related disorders has completed PhaseI clinical trials. ZYH7, a novel drug candidate for treating dyslipidemia andmetabolic disorders, ZYH2, the novel agent for treating diabetes, ZYT1, anovel TR-beta agonist for treating dyslipidemia are in Phase 1 clinicaltrials.

The Zydus Research Centre has over 20 discovery programmes on withseveral candidates in the pre-clinical development stage focused onmetabolic, cardiovascular, pain and inflammation therapeutic areas. With over375 research professionals spearheading its research programme, Zydus hasin-house capabilities to conduct discovery research from concept to INDenabling pre-clinical development and human proof-of-concept clinical trials.Media Contact : Corporate Communications, Zydus Cadila T: +91-79-26868353 E: sujatha.rajesh@zyduscadila.com

SOURCE Cadila Healthcare Limited

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