Zydus starts second trial of medicine treating anemia
Zydus today (5 July,2017) has announced the initiation of a phase II trial investigating ZYAN1, an oral hypoxia- inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a treatment for anemia associated with chronic kidney disease (CKD).
Pankaj Patel, Chairman & Managing Director, Zydus Cadila said, “We have observed desired pharmacokinetic & safety profile in addition to positive signals in biomarker responses, including erythropoietin increase with ZYAN 1 in the two phase I trials that were conducted in Australia and India. ZYAN1 could provide an oral, safer alternative to currently available erythropoietin-stimulating agents (ESAs), which are associated with an increased risk of CV events, and must be given via injections.”
Anemia is a global public health problem affecting both developing and developed countries. Anemia commonly arises in kidney disease patients, because the kidneys no longer produce sufficient amounts of erythropoietin, a hormone which stimulates red blood cell production. Symptoms of anemia may include fatigue, skin pallor, shortness of breath, light-headedness, dizziness or a fast heartbeat.
Two phase I trials of ZYAN 1 have been concluded in Australia and India, and results were recently published in Clinical Pharmacokinetics. ZYAN1 was safe and well-tolerated in healthy volunteers following single escalating oral doses (10—300 mg) and multiple escalating oral doses (100—300 mg). The measurement of serum erythropoietin (EPO) levels in healthy volunteers confirmed the pharmacodynamic effect as EPO increased with increasing ZYAN 1 doses in relation to placebo.
