NovaLead Pharma, a Pune based pharma company, has received ‘in principal’ clinical trial permission with DCG (I) for its repurposed drug discovery to treat moderate Covid-19 patients.
The company has stated that this approved drug codenamed -NLP21- is in human use for several years for its original use without any side effects of concern. 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.
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, says the company.
Mr. Supreet Deshpande, CEO, NovaLead Pharma, said, “NLP21 shows promising ability of acting 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.”
“In addition, NovaLead has established that NLP21 has potential to inhibit expression of relevant cytokines which get excessively generated in moderate to severe Covid,” he added.
He further said, “To the best of our knowledge, NovaLead trial is only the second Phase 3 clinical trial permission given by DCG(I) in India. From application submission to in-principal permission, the duration was only four days.”
“We thank the experts and the DCG(I) for such 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.”
NovaLead Pharma’s head of research, Dr. Sudhir Kulkarni, said, “This study will be on 100-150 hospitalized patients who presently need oxygen support but do not need mechanical ventilator. 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 presently employed standard of care. We expect this trial to be completed in next 3-4 months.”