Zydus Cadila, an Ahmedabad-based innovative, global pharmaceutical company, has completed the single ascending dose (SAD) range finding studies of ZYAN1 in healthy human volunteers as a part of the phase I study currently ongoing in Australia. The molecule, ZYAN1 is an orally bioavailable hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor being developed for the treatment of anaemia. ZYAN1 has been designed to increase the natural production of erythropoietin (EPO) in anaemic patients.
Anaemia is a condition of having lower red blood cells or lower hemoglobin levels than is normal. Anaemia is a serious medical condition linked to increased morbidity and mortality, and is commonly observed in patients with chronic kidney disease (CKD). Currently available agents for the treatment of anaemia include injectable EPO stimulating agents (ESA’s) and intravenous iron supplements. The estimated global market for treatments for anaemia related to CKD is $10 billion.
“This is an important innovation that will radically change the treatment paradigm in anaemia”, said Pankaj R Patel, chairman and managing director, Zydus Cadila. “ZYAN1 has the potential to become an oral therapy for treating patients with anaemia with significant advantages over currently available injectable EPO stimulating agents (ESAs)," he added.
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. Pharmacokinetics, erythropoietin and other biomarker responses were also measured in the healthy volunteers as part of this study. 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.