COVID-19: Zydus Cadila gets DGCI nod for Phase III clinical trials with biological therapy
Drug firm Zydus Cadila on Friday said it has received the approval from the Drugs Controller General of India (DCGI) to start Phase III clinical trials with its biological therapy PegiHep in COVID-19 patients.
The company had completed the Phase II clinical trials with PegiHep last month.
In a regulatory filing, Zydus Cadila said it has received approval from DCGI to start the Phase III clinical trials in COVID-19 patients, with its biological therapy Pegylated Interferon alpha-2b or PegiHep.
The trials, which will commence in December, will be conducted on 250 patients across 20-25 centres in India, according to the filing.
Sharvil Patel, Managing Director of Cadila Healthcare Ltd, said, "we are encouraged by the results of Phase II study of Pegylated Interferon alpha-2b, which has shown the potential to reduce virus titres when given earlier in the disease.
"Our efforts are to look at possible treatment options to fight COVID-19 which are safe, can be administered easily and also reduce the disease burden," he added.
Further, the company said it is conducting a similar Phase II trial in Mexico and is also working with the US Food and Drug Administration (USFDA) to open an Investigational New Drug (IND) application for PegiHep in order to initiate appropriate clinical trials in the US.
In another development, Rhizen Pharmaceuticals, an associate company of Alembic Pharmaceuticals said it has received approval from the US health regulator to commence Phase I clinical trials on retroviral oral drug for the treatment of COVID-19.
The Switzerland-based firm, which is a clinical-stage oncology-focused biopharmaceutical company, has received approval for its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to study its oral Dihydroorotate dehydrogenase (DHOHD) inhibitor for SARS-CoV-2 virus, Rhizen Pharmaceuticals S A said in a statement.
The initial study would evaluate single ascending doses of the RP7214 in healthy volunteers and that dosing is expected to commence in early December, it added.
(Disclaimer: Additional background information has been added to this PTI copy for context)