Zydus seeks DCGI’s permission to study new anti-diabetic molecule ZYD1

ZYD1 belongs to a new class of anti-diabetic drugs represented by Eli Lilly-Amylin drug Byetta

Zydus Cadila of Ahmedabad, western India has filed an application seeking permission from Drug Controller General of India to conduct clinical studies for its investigational new molecule ZYD1 to treat diabetes.

Zydus Cadila has filed investigational new drug application (IND) –filed for initial studies for experimental molecules – for ZYD1, a drug candidate designed and developed at  the Zydus Research Centre.

ZYD1 belongs to a class of blood glucose reducing agents called GLP-1 agonists. These anti-diabetics.

Also known as incretin mimetics these new are poised to dominate the future of anti-diabetic therapy and presents a huge opportunity in bridging unmet medical needs that still continues to dodge the treatment and care of diabetes, the company said in a press statement.

“The discovery of the novel GLP-1 agonist, ZYD1, using our discovery platform technology is an important achievement for us. We believe that it holds promising commercial potential as a best-in-class candidate due to unmet medical needs in the treatment of diabetes,” stated Mr. Pankaj R Patel, chairman and managing director, Zydus Cadila.

ZYD1 has displayed a better efficacy and safety profile and demonstrated beneficial effects in preclinical animal models on glucose reduction, HbA1c reduction and added benefits of weight loss. 

In addition, ZYD1 showed a differentiated preclinical safety profile with no nausea-like symptoms and absence of antibody generation in the preclinical studies.

ZYD1 is the latest in Zydus Cadila’s research pipeline which comprises of 6 investigational molecules in various stages of clinical trials. The molecule ZYH1, for treating dyslipidemia is undergoing Phase III clinical trials. ZYI1, the anti-inflammatory and pain management compound is currently in Phase II clinical trials. ZYO1, a novel drug candidate for treating obesity and related disorders has completed Phase I clinical trials. ZYH7, a novel drug candidate for treating dyslipidemia and metabolic disorders, ZYH2, the novel agent for treating diabetes and ZYT1, a novel drug candidate for treating dyslipidemia are in Phase 1 clinical trials.

The Zydus Research Centre has over 20 discovery programmes ongoing with several candidates in the pre-clinical development stage focused on metabolic, cardiovascular, pain and inflammation therapeutic areas. Zydus has inhouse capabilities to conduct discovery research from concept to IND enabling pre-clinical development and human proof-of-concept clinical trials.

The number of diabetics in the world, now estimated to be 246 million, is expected to increase rapidly to 380 million in 2025. Currently 41 million (16.6%) of the diabetic population lives in India and it is expected to rise to 70 million (18.4%) in 2025. In 2025 nearly half of the world’s diabetic population will be from India, China, Brazil, Russia and Turkey.
Research in the field of anti-diabetic therapy seeks to address the problems of hypoglycemia, GI side effects, lactic acidosis, weight gain, CV risks, edema, potential immunogenicity etc., which pose a major challenge in the treatment of diabetes. The global anti-diabetic market was estimated at $24 bn in 2008.

Incretins or GLP-1 agonists: Safer anti-diabetics

The first incretin released by the FDA was Byetta produced by Amylin and Lilly,which was approved in May of 2005. GLP-1 agonists or drug that works like GLP-1. It is rather unusual in that it is derived from a compound found in the saliva of the Gila monster, a large lizard native to the southwestern US.

When food is eaten, GLP-1 (glucagon-like peptide 1) is one of several incretin compounds that have biologic activity. Following its release into the blood by the intestine in response to food intake, GLP-1 impacts several organs including the intestines where it slows food absorption. This delay in absorption allows the slow insulin response found in Type 2 diabetes to catch up. Rather than being glucagon-like and raisining glucose levels, GLP-a agonists lessen the excessive release of glucagon seen in Type 2 (and Type 1) diabetes.Giving natural GLP-1 was found to have little benefit because it is broken down by an enzyme called DPP-4 (dipeptidyl peptidose IV) within about 5 minutes. Related to the GLP-1 agonists is a second new class of diabetes medications called DPP-4 Inhibitors which work by delaying the breakdown of GLP-1, as well as other incretins. Because DPP-4 is involved in the break down of several peptides in the body, it will take time to be sure there are no unwanted long-term side effects.