Zydus Cadila has received approval from the regulatory authority of Mexico, COFEPRIS, for one of its lead research candidate, Desidustat, to be tested in the management of COVID-19. The company said clinical and regulatory development of Desidustat in COVID-19 is being executed in Mexico by Avant Sante Research Center SA de CV, a leading Contract Research Organisation (CRO) headquartered in Monterrey, Mexico.
The company said Desidustat is currently undergoing phase 3 trials. It mimics the physiologic effect of altitude on oxygen availability. The company will now be conducting a phase 2b, multicenter, open-label, randomised, comparator-controlled study to evaluate the efficacy and safety of Desidustat tablet. As a part of the study, 100 mg tablets of Desidustat will be administered for 14 days during the trial.
"At higher altitudes, the body responds to lower oxygen availability with stabilisation of hypoxiainducible factor, and this can lead to increased red blood cell production and improved oxygen delivery to tissues," the company statement said. "At Zydus, we have been stepping up our efforts to fight the Covid-19 pandemic through therapeutic drugs, diagnostics and vaccines. With Desidustat we will study a novel approach for management of Covid-19," said Pankaj R Patel, Chairman, Zydus Cadila.
Zydus had initiated two Phase III trials of Desidustat. As per the company, the DREAM-ND Phase III trial is being conducted in 588 CKD patients not-on-dialysis and 392 CKD patients on dialysis. Desidustat had previously met its primary endpoints in the Phase II clinical studies and showed good safety profile. The Phase I trials were earlier completed in Australia.
Zydus Cadila has also got approval for Phase-I and Phase-II trials for its candidate vaccine ZyCoV-D in India. Zydus has claimed that it has already manufactured clinical batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1,000 subjects.
Apart from that, Covaxin, a coronavirus vaccine candidate being developed by Bharat Biotech in collaboration with ICMR-National Institute of Virology, Pune, has also received approval for Phase I and II clinical trials in India Bharat Biotech is also developing two more vaccines for COVID-19 with international alliances. One is with the Thomas Jefferson Institute in the USA using an inactivated rabies virus platform and another named CoroFlu with the University of Wisconsin-Madison and biotech firm FluGen.Also read: ICMR defends fast-tracking Covaxin trials after backlash over August 15 deadline