IICT partners with Mylan for combination therapy trials

Hyderabad-based Indian Institute of Chemical Technology (IICT) has partnered with the Indian subsidiary of global pharmaceutical company, Mylan, to test combination therapies for coronavirus disease (Covid-19).

The institute had identified first three combination therapies, for Phase 3 clinical trials, based on computational modelling of molecules and laboratory-based data. Another five combinations are also in the works and will be finalised after preliminary data for the same is received.

“Mylan is a global company with a big portfolio of antiviral drugs. Some of these drugs, in combination with antibiotics or other medicines, will be used for the first three-arm trial. All the drug combinations that we are working on include either one or two antibiotics in combination with medicines that boost the immunity of the host or make the human cells not receptive to the virus. So, the drug combinations will work both on the virus and the host to produce the best results,” said Dr S Chandrashekhar, director, IICT.

He said the first three combinations to be tested will have the antiviral drug Favipiravir, currently in use for treatment of mild to moderate Covid-19 symptoms, antiviral drugs used against Hepatitis C, and antiviral drugs used against HIV.

“Some of these antiviral drugs have received a nod for experimental use by the drug controller, but these trials will actually produce data to show how effective the drugs are. And, Mylan, being a big global company, can use the data for global approvals,” he said.

The trial sites for the combination therapies are yet to be identified, but the institute hopes to collaborate with hospitals in four to five cities in India.

“We are still looking for clinical partners — maybe in Hyderabad, Delhi, and even Kolkata. Anywhere between 100 to 400 patients will be enrolled for the trials,” said Dr Chandrashekhar.

Only adult patients with mild to moderate Covid-19 at risk of complications will be enrolled for the trials. The application for conducting the trials has been submitted to the Drug Controller General of India, he said.

“The current collaboration with Mylan is a significant milestone during the current Covid-19 pandemic. CSIR {Council of Scientific and Industrial Research} has prioritized conducting clinical trials of well-proven drugs in partnership with industry towards the development of multiple therapeutic options for Covid-19,” said Dr Shekhar Mande, director general of CSIR, in a release.

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