New Delhi: A panel of experts under the Narendra Modi government has approved the phase 2 clinical trial of novel anti-cancer drug Bemcentinib as a potential treatment for Covid-19.
Manufactured by Norway-based biopharmaceutical firm BerGenBio, the drug is the first candidate selected to be fast-tracked as potential treatment for Covid-19 by the UK government under its initiative ‘Accelerating Covid-19 Research & Development’ study, popularly known as the ‘ACCORD study’.
ACCORD is a single clinical trial platform intended to assess drug candidates in early stage trials and advance them into the country’s large-scale Covid-19 studies, such as the RECOVERY trial, which is currently the world’s largest randomised controlled clinical trial for Covid treatment.
In India, the government’s subject expert committee (SEC) has recommended granting permission to conduct the clinical trial of Bemcentinib. The SEC advises the apex drug regulator, Drug Controller General of India, on applications seeking approvals for new drugs, vaccines, and clinical trials.
The proposal to conduct trials was filed by US-based health research company IQVIA, which is handling the trials of the drug in the UK as well.
According to the BerGenBio’s website, the preclinical data on the drug indicates that “it is potentially useful for the treatment of early SARS-CoV-2 infection”.
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Bemcentinib & how it can work against Covid
According to the BergenBio’s website, the novel drug Bemcentinib is a once-a-day, oral drug that has previously demonstrated a key role in cancer treatment.
The drug has proved to prevent “immune evasion, drug resistance and metastasis in a variety of cancer trials”.
Also, the company claims, it is known to exhibit potent anti-viral activity in preclinical models against several enveloped viruses, including Ebola and Zika.
“Bemcentinib has been seen to inhibit virus entry into cells, suggesting it is potentially useful for the treatment of early SARS-CoV-2 infection,” it said.
“Bemcentinib prevents inhibition of Type I Interferon, which is the cell’s anti-viral defence mechanism, again suggesting valuable utility in treatment of SARS-CoV-2 infection.”
Moreover, the company also claims that “the drug has to date been shown to be safe and well-tolerated in hundreds of patients and in many cases taken daily for several years”.
What the panel recommends
The decision was taken by the SEC in a meeting on 28 September. The minutes of the meeting were uploaded on the Central Drugs Standard Control Organisation’s (CDSCO) website. The CDSCO is the health ministry arm that regulates the quality of drugs and vaccines in the country.
The panel trifurcated the analysis of the US company’s proposal submitted along with the phase 2 clinical trial protocol.
Firstly, the committee considered “assessment of risk versus benefit to the patients”. It noted that “the safety profile of the study drug as anti-cancer from preclinical toxicology studies including repeat dose toxicity, phase 1 and 2 clinical study under the oncology category is defined”.
It also looked at the “innovation vis-à-vis existing therapeutic option”.
On this point, it clarified that “the purpose of the study is to assess the safety and efficacy of Bemcentinib, a new chemical entity for the treatment of Covid-19 in hospitalised patients with primary objectives (of efficacy) and other secondary objectives.”
Lastly, the panel considered “unmet medical needs in the country” and chose to give a go-ahead.
“As on date, there was no approved and effective treatment for Covid-19. After detailed deliberation, the committee recommended for grant of permission to conduct the clinical trial subject to the following conditions…,” it said.
The conditions
The panel has suggested that the company should include only those Covid patients who fulfil the Indian criteria for “moderate Covid-19 patients” apart from following the World Health Organization’s guidelines.
It has further asked the company that the “sample size in India should be 60, which means 30 patients in each arm”.
Under the ACCORD trial, the drug is being tested on 120 subjects — 60 hospitalised Covid-19 patients and 60 control group patients receiving standard of care treatment.
Also, the company has been instructed to appoint the Data and Safety Monitoring Board — which is an independent group of experts to recommend changes — “for safety monitoring of the trial”.
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