In race to stop Covid-19, Indian drugmakers to conduct clinical trials

Glenmark, Zydus Cadila to start trials in May

If the trials go along expected lines, we will soon have an antiviral drug (Favipiravir) for Covid-19 patients in the market.

Glenmark Pharmaceuticals is all set to start clinical trials on mild to moderate coronavirus-positive patients in May.
 

Meanwhile, several other Indian firms are stepping up efforts to start clinical trials on other drug candidates — such as biologic drug Interferon alfa-2b and antiviral drug Remdesivir.
 

Cadila Healthcare (Zydus Cadila) will start clinical trials on Interferon alfa-2b, a drug that it already makes commercially for Hepatitis C, for the novel coronavirus.

Meanwhile, industry sources claim that Hyderabad-based Dr Reddy’s Laboratories (DRL) is close to signing a voluntary licence agreement with Gilead to make the latter’s patented antiviral drug Remdesivir.
 

Bengaluru’s Strides Pharma Science, which started exporting Favipiravir, is also applying for approval for the antiviral in India.

The stocks of both Glenmark and DRL went up on Thursday by 2.3 per cent and 1.3 per cent, respectively. Cadila Healthcare, however, was marginally down. Strides, too, was down 2.8 per cent.
 

Mumbai-based research-driven drug major Glenmark on Thursday said it has received the drug controller’s approval to conduct clinical trials on Favipiravir, sold under the brand name Avigan by Fujifilm Toyama Chemical Co. in Japan for influenza. Fujifilm has already started Phase 3 trials on Favipiravir for novel coronavirus and has also increased the drug’s production.
 

Glenmark will start clinical trials on Favipiravir in May in different centres across the country on 150 patients. The preparations are in place and the trial would be over in May. Around 150 subjects with mild to moderate Covid-19 will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care.

“Treatment duration is a maximum of 14 days and the total study duration will be a maximum 28 days from randomisation,” the company said. It added that the company has internally developed the active pharmaceutical ingredient for Favipiravir and would be the first pharmaceutical firm in India to start the Favipiravir trials.
 

Industry sources revealed that if Glenmark’s trials prove successful, the drug could be made available very soon. “Several companies are ready to make the drug and they can even launch it, based on Glenmark’s trial outcome. Everyone does not need to run a clinical trial now. The government is moving at unbelievable speed, and the approvals to launch the drug will be expedited too,” he said.
 

Being an oral drug, the pricing of Favipiravir is not expected to be very high either.

Meanwhile, Strides is in the process of applying ‘expeditiously’ for the approval of the antiviral in India. While the company did not reveal the clinical trial timeline for the drug in India, it said it is evaluating other antivirals that are potentially being considered for Covid-19.
 

“We are evaluating other antivirals that are being potentially considered for Covid-19. However, we would not be able to share names at this stage,” said a Strides spokesperson. According to reports, the company has also looked at Remdesivir as a part of its antiretroviral therapy programme. 

Industry experts say it usually takes 11-12 months for a drug to be approved and rolled out in the market. “However, since this is a special case of Covid-19, the process has been expedited and the drug might be available in the market in the next two-three months,” said pharma analyst Amey Chalke.

Cadila is gearing up to start clinical trials of Interferon alfa-2b, a biosimilar used to treat Hepatitis C, and the company already makes it commercially. The trials will start in May, informed a senior company executive.
 

Zydus has approached the Department of Biotechnology to investigate the role of Pegylated Interferon alfa-2b for Covid-19.

A study by the University of Texas Medical Branch, Galveston, demonstrated around 10,000-fold reduction in-virus titer in cells that were pre-treated with Interferon alfa-2b 48 hours earlier.

Studies suggest that given in early stages of the infection, Interferon alfa-2b patient can have significant benefit by reducing the viral load. Interferons are the first line of defence of the human body against a viral attack.
 

Another drug in focus now globally is Remdesivir. On Wednesday, innovator Gilead said the National Institute of Allergy and Infectious Diseases (NIAID) trial had shown that its repurposed drug Remdesivir, originally developed for Ebola, helped patients recover quicker than standard care.

US government’s top infectious disease expert Anthony Fauci, head of NIAID, said the early results of this trial offered ‘good news’. 

Reports suggest that Gilead’s Chief Executive Officer Daniel O’Day has said the company will ensure access is not an issue with this medicine. This is positive news for countries like India, as Remdesivir is patent protected till 2035. Multiple industry sources suggested that Gilead and DRL were close to sign a voluntary licence agreement that will allow DRL to make the drug for the Indian market. DRL did not wish to comment on speculation.
 

Several Indian companies, according to sources, are working on Remdesivir, so far considered to be the most promising drug against coronavirus. “While companies are working on Favipiravir, results from the Remdesivir study are likely to be more promising. We are, however, not starting trial production or studies on the drug yet until results from the US study come, which may take around a month,” said the head of a leading pharma company in India.
 

Apart from antivirals, drugs such as Sepsivac (used for blood poisoning or sepsis) will soon be used in patient trials. The government itself plans to do the Sepsivac trials.