India gears up for patient trials on 20 different drugs for Covid-19

Local pharma units have already started work on developing patented drugs, some have already approached regulator for approvals

In the search for a potential line of treatment, India is lining up patient trials on about 20 different drugs, which include patented anti-viral drugs like Favipiravir. Local pharma companies have already started developing patented drugs, and some have approached the country's drug regulator for approvals.
 

Apart from anti-virals, drugs such as Sepsivac (used for blood poisoning or sepsis) and Interferon alpha 2b (a biologic) will soon be used in patient trials. A government official noted that different drugs are being considered including anti-virals. Some of these trials will be conducted by companies, while other by the government.
 

The key drug in focus was a broad spectrum anti-viral Remedesivir innovated by US-based pharma major Gilead initially for Ebola. It was found to be useful against coronavirus like SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). According to some recent studies, the drug had shown promising results in initial trials.

However, latest updates from an inadvertently released study on the World Health Organization website showed the drug failed in final trials in China.

Gilead, however, has contested. In a statement, the company said: “We believe the post included inappropriate characterisations of the study. The study was terminated early due to low enrollment and, as a result, it was underpowered to enable statistically meaningful conclusions. As such, the study results are inconclusive, though trends in the data suggest a potential benefit for Remedesivir, particularly among patients treated early in disease.”
 

Even as the debate on Remedesivir rages, several Indian drug makers have started developing it. Industry sources on Friday indicated that patient trials on Remedesivir might be put on hold until some clarity emerges. But work on other drugs will begin soon.
 

Another anti-viral drug, which is sold in Japan under the brand name Avigan to treat influenza, is showing promise. Fujifilm Toyama Chemical has started a Phase-3 trial in Japan to test the drug’s efficacy against Covid-19. Even the Council of Scientific and Industrial Research (CSIR) has completed synthesis of the anti-retroviral drug Favipiravir and handed it over to a private company that has approached the Drug Controller General of India (DCGI) for approvals.
 

While Gilead has a patent till 2035 for Remedesivir (and it has a patent registration in India), the primary patent protecting Favipiravir has expired in 2019. “There are some supplementary patents that now protect the drug in India. But, the government is actively using it on patients,” said an industry source.

Meanwhile, Mumbai’s Glenmark Pharmaceuticals has approached the DCGI for approvals. It would now test the drug on around 100-150 patients in a Phase-3 trial. This should take around a month as the drug-course is for 14 days.
 

If the results are satisfactory, the drug can be recommended as a line of therapy and included in the Indian Council of Medical Research’s (ICMR’s) protocol.
 

“Making the active pharmaceutical ingredient (API) for Favipiravir was the challenge. It has finally been cracked, and now it can be made in India. Once the trials are over, other companies can also quickly make the drug if the ICMR recommends it as treatment,” said another industry source.
 

Indian drug firms are actively working on developing anti-virals. Major firms such as Zydus Cadila, Cipla, Glenmark, and Dr Reddy’s Laboratories are on the forefront.

Zydus Cadila has said it has the capabilities to develop Remedesivir if required for patient trials. Similarly, Cipla is learnt to be working on both Remedesivir and Favipiravir. A Cipla spokesperson said the company was unable to share a comment at the moment, but would update in case of any development.

Government sources indicated that India is keen to try these drugs on Indian patients. “For this, it is important that the drugs are locally available and not imported. At the moment even Gilead is not making Remedesivir commercially,” said a senior government official. For Covid-19, it is a race against time, he said.
 

The government can invoke the Indian Patents Act and allow local manufacturing under compulsory licence for patented drugs.  Pharma industry sources highlighted that companies can procure a patented drug in small quantities for research purposes. In the face of a medical emergency like the current pandemic, these drugs can be manufactured by the drug makers under a licence from the innovator.

Once local manufacturing starts, the clinicians are likely to administer the drug to Covid-19 patients under compassionate use programme (CUP). A CUP is one where a drug is administered to a patient for a disease for which it has not yet been approved for treatment of that particular disease.
 

Drugs like Sepsivac would be tested on over 500 patients to see if it boosts the immunity against the virus. Meanwhile, Zydus has indicated that it is willing to start trials for Interferon alpha 2b that is expected to block the virus from replicating. The company already commercially makes it under brand Pegihep.