SHASHWAT GUPTA RAY
shashwat@herald-goa.com
VASCO: A generic antiviral drug named Umifenovir has been developed to treat Covid-19 by premiere government drug research laboratory the Council for Scientific and Industrial Research-Central Drug Research Institute (CSIR-CDRI), Lucknow, in collaboration with Medizest Pvt Ltd, Goa.
This drug is currently undergoing large-scale, multicentric Phase 3 clinical trials. The trials are expected to be completed by the end of 2022.
“After the CDRI had devised the molecules required to treat the disease, we were looking for an industrial partner to manufacture the drug, at that time one of the companies which came forward was Medizest from Goa,” Dr Ravishankar Ramachandran, the nodal scientist and Project Team Lead at CSIR-CDRI told Herald.
Dr Ramachandran was speaking on the sidelines of the two-day International Drug Discovery Conference inaugurated at BITS Pilani Goa Campus, on Thursday.
He said that the Covid outbreak was an emergency situation in the country and the lab started contacting pharma companies to partner with it to bring out the medicine into the market at the earliest.
“We did contact some of the big guns in the pharma industry at that point of time. But it was Medizest which showed a lot of enthusiasm. We had a common interest in making sure that the molecules for Covid come to the market for the country,” he said.
The senior scientist said that a smaller company has more hunger and flexibility in its functioning. So, while in the case of a bigger company the decision making process may take a long time and business consideration is more important, sometimes smaller companies think from the heart.
Speaking about the drug, he informed that Umifenovir was selected from a list of 16 candidates after a detailed evaluation of the mechanism of action, feasibility of synthesis and published safety studies.
“The data from studies performed at CDRI, prompted the team to propose the testing of the drug at a dose of 800 mg twice a day, as opposed to the previously approved maximum dose of 200 mg three times a day. Following approval by the Drug Controller General of India (DCGI), Umifenovir was tested in a Phase III, randomised, double-blind, placebo controlled clinical trial for efficacy, safety and tolerability in non-severe Covid-19 patients last year,” he said.
“Umifenovir has an excellent safety profile. It has been used as a safe, over-the-counter drug to treat adults, children and pregnant women for influenza and pneumonia for over 20 years in Russia, China and other countries,” the CSIR-CDRI chief scientist said.
He said that the faster recovery of patients could reduce virus shedding and consequent spread of the infection to others.
“The drug could also be tested in special populations such as pregnant women and children, a group for which Covid-19 specific antiviral drugs are not currently indicated. The current ongoing Phase 3 will help establish the efficacy and safety of the drug in a larger number of subjects, paving the way for marketing approval for Medizest,” the senior scientist added.
The company officials refrained from commenting.