Pune-based drug discovery company NovaLead Pharma has received final phase clinical trial permission from the Indian regulator Drug Controller General of India (DCGI) for an undisclosed repurposed drug, which it claims to have shown better efficacy than any existing treatments currently being used in COVID-19 treatment across the world.
Codenamed NLP21, NovaLead said the drug is in human use for several years for its original use without any side effects. A comparable study conducted by reputed laboratories in South Korea and the United States has shown better viral inhibition ability than Remdesivir, Fevipiravir, Hydroxychloroquine and Lopinavir/Ritonavir. These drugs are currently being tested for treating COVID-19 worldwide, but are yet to conclusively prove efficacy.
"It shows promising ability in the treatment as it prevents virus from binding to the human cells and reduce the viral load and also clears damaged human cells to allow regeneration of healthier cells. These are essential to address COVID-19 infection effectively," said Supreet Deshpande, CEO of NovaLead.
Further, the drug has shown ability to prevent multiplication of the disease causing germs. According to him, the trial permission was given in four days. Normally in India, an approved drug does not require elaborate data and clinical trials for getting approved for use in other diseases. NovaLead claims its trial drug will be the second drug for treating COVID-19 to enter Phase 3 trials in India .
NovaLead Pharma's head of research, Dr Sudhir Kulkarni said the Phase 3 trial will be done on 100-150 hospitalised patients who presently need oxygen support but do not need mechanical ventilator. The patient shall be in trial for 21 days and NovaLead plans to complete the trials in 3-4 months.
He said NovaLead is masking the name of the drug, because unlike some other drugs in 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. Its second repurposed candidate drug NLP91 for the treatment of psoriasis, will begin clinical trial in 2021.