Zydus completes Phase I trials of anaemia drug

Ahmedabad-based drug major Cadila Healthcare Ltd (Zydus Cadila) today announced that it has completed the single ascending dose (SAD) range finding studies of ZYAN1 (used in patients with anaemia) in healthy human volunteers as a part of the Phase I study currently ongoing in Australia.

The company said in a release that, "The molecule, ZYAN1 is an orally bioavailable hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor being developed for the treatment of anemia. ZYAN1 has been designed to increase the natural production of erythropoietin (EPO) in anemic patients."

Anemia is a condition of having lower red blood cells or lower hemoglobin levels than is normal, and is linked to increased morbidity and mortality, and is commonly observed in patients with chronic kidney disease (CKD). Zydus claimed that currently available agents for the treatment of anemia include injectable EPO stimulating agents (ESA’s) and intravenous iron supplements. 

The estimated global market for treatments for anemia related to CKD is $10 billion.

Pankaj R. Patel, chairman and managing director, Zydus Cadila said, “ZYAN1 has the potential to become an oral therapy for treating patients with anemia with significant advantages over currently available injectable EPO stimulating agents (ESAs)."

The Phase I study was designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of ZYAN1 in healthy volunteers. During the dose ranging study, ZYAN1 was administered up to 150 mg orally, once-a-day to healthy human volunteers as part of single ascending dose finding studies. The company siad that now the multiple ascending doses of ZYAN1 in healthy human volunteers have been initiated. In addition, the effect of food and gender on the pharmacokinetics of ZYAN1 will also be studied.