Zydus said it started phase II trial on its anemia drug candidate ZYAN1.
The drug, a hypoxia-inducible factor prolyl hydroxylase inhibitor, is being tested as a treatment for anemia associated with chronic kidney disease (CKD).
The move follows successful Phase 1 trials. A drug has to go through three phases of clinical trials before it is submitted for approval.
Phase I trials of ZYAN1 were conducted 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 ZY AN1 doses in relation to placebo,” the company said.
The drug is supposed to inhibit hypoxia-inducible factor prolyl hydroxylase and thereby increase the natural production of hemoglobin and red blood cells in anemic patients.
ZYAN1 has been shown to improve iron mobilization and has the potential to reduce or eliminate the need for iron supplementation, the company said.
“We have observed desired pharmacokinetic & safety profile in addition to positive signals in biomarker responses, including erythropoietin increase with ZYAN1 in the two phase I trials that were conducted in Australia and India” said, Pankaj Patel, Chairman & Managing Director, Zydus Cadila.
“ZYANl has the potential to bring about a paradigm shift in the management of patients with anemia as it 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. Zydus is committed to bring this therapy to millions of patients suffering from anemia,” he added.
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. The Global ESA Market was estimated at USD 7 billion worldwide.