Pune-based NovaLead gets DCGI nod to test old drug against COVID-19

NovaLead Pharma, the Pune-based company which is into drug repurposing, has received ‘in principal’ clinical trial permission from Drug Controller General of India (DCGI) for its repurposed drug discovery candidate to treat moderate novel coronavirus, or COVID-19.

This approved drug, codenamed NLP21, is in human use for several years for its original use without any side effects of concern. NovaLead is tight-lipped about naming the drug. It says that the 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.

"In a comparable viral assay study conducted by reputed laboratories in South Korea and United States, NLP21 has shown better viral inhibition ability than Remdesivir, Fevipiravir, Hydroxychloroquine, Lopinavir/Ritonavir etc," the company said.

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.

“NLP21 shows promising ability of acting on COVID-19 through multiple relevant targets. This enables NLP21 to prevent virus binding to the human cells and reduce the viral load, but clears damaged human cells to allow regeneration of healthier cells, all of which are essential to address COVID-19 infection effectively," said Supreet Deshpande, CEO of NovaLead Pharma.

"In addition, NovaLead has established that NLP21 has potential to inhibit expression of relevant cytokines which get excessively generated in moderate to severe COVID-19. To the best of our knowledge, NovaLead trial is only the second Phase 3 clinical trial permission given by DCG(I) in India," Deshpande said.

The company said it took just four days from application submission to in-principal permission from DCGI.

The company said it expects Biotechnology Industry Research Assistance Council (BIRAC) and other government mechanisms to support this trial as NLP21 has potential to addresses a national medical emergency.

The clinical trial will be on 100-150 hospitalised patients who need oxygen support at present but do not need mechanical ventilators. In this study, where the patient 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 the presently employed standard of care.

"We expect this trial to be completed in the next three-to-months,” said Dr Sudhir Kulkarni. Head of Research.