Pune: Pune-based NovaLead Pharma that works in the field of drug repurposing has announced it will begin its trial of drug NLP21 for coronavirus disease (COVID-19) within three weeks. The company has stated that it has received ‘in principle’ clinical trial permission with the Drug Controller General of India (DCG{I}) for the trial of NLP21.
Company to start the trial
This drug that has been used for another disease for a few years has shown the potential to act on the COVID-19. The company will be starting its trial on about 100-150 patients across the country in three weeks and will be observed for at least four months.
“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 the 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,” read an official statement.
Promising ability
“NLP21 shows the promising ability to act on COVID-19 through multiple relevant targets. It prevents virus binding to the human cells and reduces 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, it has been established that the NLP21 has the potential to inhibit expression of relevant cytokines which get excessively generated in moderate to severe COVID-19,” said company’s chief executive officer (CEO) Supreet Deshpande.
The company studied about 2,200 approved drugs over all the proteins -- near about 38 proteins that are involved in virus and human interaction.
After the computation study, the company shortlisted 42 drugs which may have the potential for the COVID-19 effect. “Out of these, we zeroed down to three drugs which we believe have strong potential for treating the pandemic and among those we approached DCG(I) for the trial of NLP21 and now will going ahead with it,” Deshpande told Sakal Times.
Trial on serious patients
The trial will be conducted upon 100-150 patients in six different hospitals across India, which will start in three weeks, and it is expected to be over in about four months, he informed. “The trials will be happening on serious patients who need oxygen right now but not mechanical ventilator. So if this works on these patients will work on almost all patients-- even those with mild symptoms will benefit from it,” he added.
Informing about the details of this proposed clinical trial, the company’s head of research, Dr Sudhir Kulkarni said, “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.”
NLP21-Safe drug
Deshpande also explained that NLP21 is a safe drug. “Side effects of this drug are minor. It is imperative to consider the side effects of drugs-- we don’t want a drug which has major side effects. It has to be safe.”
“The other probable tested drugs for COVID-19 work on a single target/protein/mechanism, whereas this one works on multiple mechanisms to treat the viral infection. So whatever may be the extent of the infection, this drug probably will have an effect. Also, when it was studied in viral culture, the effect of this drug that was observed is better than the others. It reduces the viral load effectively within the approved dose of the drug (which is already prescribed),” he said.
3 clinical trial permission
Deshpande stated that to the best of our knowledge, the company’s trial is only the second Phase 3 clinical trial permission given by DCG(I) in India. “We now expect Biotechnology Industry Research Assistance Council (BIRAC) and other government mechanisms to support this trial as NLP21 has potential to addresses a national medical emergency,” stated the official statement.
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.
