New Delhi: The Narendra Modi government’s subject expert committee (SEC) is considering a proposal to allow Phase III testing of an asthma-inhaler drug for Covid-19. The expert panel is also considering the last stage trial of two artificial antibodies that have shown protection against Covid-19 in previous smaller trials.
The first proposal was submitted by Parexel, an Indian clinical research organisation, for testing SNG001, an inhaled drug that contains an antiviral protein called interferon beta (IFN-β).
SNG001 is manufactured by Synairgen Research, a UK-based drug discovery and biotech firm which was earlier evaluating it as a treatment for chronic obstructive pulmonary disease (COPD) and asthma.
The second proposal is to allow Phase III trials of investigational monoclonal antibody therapy called ‘BRII-196 and BRII- 198’ to counter Covid-19. BRII-196 and BRII- 198 are the two experimental antibodies that are likely to target SARS-CoV-2 virus. They are manufactured by Shanghai-based Brii Biosciences.
While discussing the two proposals on 11 February, the SEC took note of the country’s “unmet medical needs”. It also observed how both drugs “may potentially provide treatment of patients hospitalised due to moderate Covid-19”. The minutes of the meeting were uploaded on Central Drugs Standard Control Organisation’s (CDSCO) website.
The SEC advises the Drug Controller General of India (DCGI), the country’s apex drug regulator, on applications seeking approvals for new drugs, vaccines and clinical trials. The DCGI heads the CDSCO, the health ministry arm that regulates the quality of drugs and vaccines in India.
How these ‘potential drugs’ may work against Covid-19
IFN-β in SNG001 has been shown to protect cells against the MERS and SARS viruses. IFN-β is produced in the lungs during viral infections.
The experimental monoclonal antibody therapy — ‘BRII-196 and BRII- 198’ — is part of the trial known as ACTIV-2, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) which is part of the National Institutes of Health.
Antibodies are proteins generated by the human immune system to fight foreign elements that can cause infection. Antibodies bind themselves to viruses and stop them from infecting human cells. Similarly, BRII-196 and BRII-198 are synthetic antibodies made to replicate the function of human antibodies against the novel coronavirus.
According to the minutes of the meeting, the SEC has asked both firms to submit their revised clinical trial protocol for further review.
The SEC panel also noted that preclinical studies have shown the drugs to be safe. The panel is now considering trial of SNG001 to check its “efficacy and safety” for the treatment of patients hospitalised with “moderate Covid-19” symptoms.
The panel has asked Gurugram-based Paraxel to submit further data for review, which includes details of phase I and II clinical trials of SNG001 in bronchial asthma, COPD and Covid-19. Paraxel has also been asked to submit specific data related to anti-SARS Covid-19 activity of the drug.
For BRII-196 and BRII-198, PPD, a clinical research organisation which is leading its trial in the US along with NIAID, had presented a clinical trial study protocol. The SEC has now recommended that the therapy should be tested for understanding its safety and efficacy in people with “mild or moderate Covid-19” symptoms.
The SEC has also asked PPD to include clinical trial sites from different geographical regions of the country and to also involve government institutions. The company will also submit a “list of prohibitory medicines” that should be mentioned in exclusion criteria of participants involved in the trials.