Pune-based NovaLead Pharma has received ‘in principle’ clinical trial permission from Drug Controller General of India (DCGI) to understand how its repurposed drug candidate could treat Covid-19. This approved drug codenamed NLP21 is in human use for several years for its original use without any side effects of concern, the firm said in a release.

NovaLead is masking the name of the drug, because unlike some other drugs in the trial, this drug is readily available off the shelf and therefore there is a risk that public may try to consume it even before the clinical trial is completed.

Informing about the details of this proposed clinical trial, NovaLead Pharma’s head of research, Sudhir Kulkarni said, “This study will be on 100 to 150 hospitalised patients who presently need oxygen support but do not need a mechanical ventilator. In this study where the patients shall remain in trial for a maximum of 21 days, we expect to establish the ability of NLP21 to reduce SARS-CoV-2 viral load in patients way better and faster than presently employed standard of care. We expect this trial to be completed in next the 3 to 4 months.”

Supreet Deshpande, CEO of NovaLead Pharma said, “NLP21 shows the promising ability to act on Covid-19 through multiple relevant targets. This enables NLP21 not only to prevent virus binding to the human cells and reduce the viral load but also clears damaged human cells to allow regeneration of healthier cells all of which are essential to address Covid-19 infection effectively. Besides, NovaLead has established that NLP21 has potential to inhibit expression of relevant cytokines which get excessively generated in moderate to severe Covid-19.”

He further stated, “To the best of our knowledge, NovaLead trial is only the second Phase 3 clinical trial permission given by DCGI in India. From application submission to in-principal permission, the duration was only four days. Experts and the DCGI conducted an efficient review and approval process. We now expect BIRAC and other government mechanisms to support this trial as NLP21 has potential to addresses a national medical emergency.”

"In a comparable viral assay study conducted by reputed laboratories in South Korea and the United States, NLP21 has shown better viral inhibition ability than Remdesivir, Favipiravir, Hydroxychloroquine, Lopinavir/Ritonavir etc. All these drugs at some point or the other have been considered as probable treatments for Covid-19, but their clinical outcome is as yet inconclusive," claimed the company.

NovaLead’s discovery if successful could be the much-desired treatment which cannot only hold the risk of infection away but also help the patients to rid the infection before getting into a severe condition requiring a mechanical ventilator, the release said.

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