NovaLead Pharma has received ‘in principal’ clinical trial permission with DCG(I) for its Repurposed Drug discovery to treat moderate COVID-19.
The drug has been code named NLP21. NLP21 has shown better viral inhibition ability than Remdesivir, Fevipiravir, Hydroxychloroquine, Lopinavir/Ritonavir etc, in studies conducted by South Korean laboratories in the US.
The CEO of NovaLead Pharma, Mr. Supreet Deshpande 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-19.”
He further stated that, “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.”
Informing about the details of this proposed clinical trial, 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.”
The name of the drug is being masked because the drug is easily available commercially and there is a fear that people may try to consume the drug even before the trial is started.