Zydus Cadila (Cadila Healthcare Limited) has reported positive results from Phase 2(b) studies of Desidustat in Covid-19 patients conducted at Mexico.
In July last year, the company had received nod from the Mexican regulatory authority, COFEPRIS, for clinical trials of Desidustat for Covid-19 management. The novel mechanism of targeting ‘hypoxia’ through the HIF-PH inhibitor was studied for the first time in hospitalised Covid-19 patients in Mexico.
Zydus had conducted the Phase 2b, multicentre, open-label, randomised, comparator-controlled study to evaluate the efficacy and safety of Desidustat tablet for the management of Covid-19 patients.
Clinical and regulatory development of Desidustat in Covid-19 was executed in Mexico by Avant Santé Research Center S.A. de C.V., a leading contract research organisation (CRO) headquartered in Monterrey, Mexico.
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“Phase (2) b trial data shows the potential of Desidustat in helping prevent acute respiratory distress syndrome (ARDS). None of the hospitalised patients required mechanical ventilator in the Desidustat arm, while 25 per cent patients on the standard of care arm required mechanical ventilator,” the company said in a statement.
Pankaj R Patel, Chairman, Zydus Group, said, “We are excited to report for the first time, this encouraging data of our novel HIF-PH inhibitor, Desidustat, showing the potential to help prevent acute respiratory distress syndrome (ARDS) in Covid-19 patients. ARDS is associated with high mortality rate and Zydus remains committed to further develop this novel therapy for patients suffering from ARDS.”
Patients infected with Covid-19 have been reported to display signs of ‘Hypoxia’ leading to organ failure and death despite the use of antivirals, anti-inflammatory drugs or ventilators.
The attack with the novel coronavirus pneumonia (Covid-19) will cause less and less haemoglobin that can carry oxygen and carbon dioxide. The lung cells have been reported to develop extremely intense poisoning and inflammation, shortness of breath sets in and this can lead to acute respiratory distress syndrome (ARDS).
Patients with ARDS may require mechanical ventilator support to help circulate oxygen in the body.
“Further, the level of CRP (C-reactive protein) and IL-6 (Interleukin-6) are reported to predict respiratory failure in hospitalised symptomatic Covid-19 patients. It has been reported that the risk of respiratory failure for patients with IL-6 levels of >80 pg/ml was 22 times higher compared to patients with lower IL-6 levels,” the company stated.
“In this Phase 2(b) clinical study, the standard of care reported the mean increase in IL-6, while the Desidustat arm remained stabilised. Detailed reports will be published in a scientific journal,” it added.
Zydus had initiated two Phase-III trials of Desidustat. The DREAM-ND Phase III trial is being conducted in 588 CKD patients not on dialysis. The DREAM-D Phase III trial is being conducted in 392 CKD patients on dialysis, it added.
Desidustat is also being studied in cancer chemotherapy-induced anemia.
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.
Shares of Zydus Cadila traded positive on Monday morning at ₹463.25, up 0.6 per cent on BSE.