If things go right, a new drug (called a novel chemical entity, or NCE) developed by a Kochi-based firm can hit the market in six months. PNB Vesper, a research organisation, has got the nod from the country's drug regulator to conduct phase-2b trials of its candidate codenamed PNB-001 for Covid-19.
This would be India's first NCE to treat Covid-19 if it gets marketing approval. Globally, drug majors such as Merck are developing drugs for the Sars-CoV-2 virus and some of these global candidates have already shown promise.
PNB Vesper's drug developed from 12 years of research by the firm for small-cell lung cancer (it is under trial for the same) has shown positive response in Covid-19, the firm claimed. What's more, the drug may also have prophylactic usage - that is if one takes it according to a specified dosage, it may help to prevent getting a Covid-19 infection.
PNB Vesper will now conduct a study on 40 Covid-19 positive patients at BMJ Medical College in Pune that will be completed in 60-days. It has already identified six centers across India for phase 3 trials (over 350 patients) and that should take 3-4 months. If things go according to plan, the drug would be ready to hit markets (subject to regulator approval) by March, claimed P N Balaram, CEO of PNB Vesper Life.
PNB-001 helps to reduce the cytokine release syndrome (the adverse reaction of the body's immune system that causes inflammatory cytokines release) and can also be administered orally. "It will be in capsules form,"Balaram said. The other drugs that are being currently used to reduce cytokines release in the blood - Roche's tocilizumab and Biocon's itolizumab - are both injectables.
In the clinical trials, PNB-001 will be compared with a common inexpensive steroid dexamethasone that is being given to Covid-19 patients who need oxygen support.
The Kochi firm has patented the molecule in India, US, EU and rest of the world.
In the phase 1 trials when it was tested on 74 healthy subjects in low, medium and high doses, the drug was found to be 'extremely safe', PNB Vesper said.
An upbeat Balaram said that the drug was highly potent and had multiple usages. "For most patients there may not be any need to take other drugs. It works more efficiently than aspirin, it boosts the body's immune response, and also reduces inflammation causing cytokine release. It can thus help a patient from slipping into a more severe stage of the disease," he said.
Clinicians Business Standard contacted have not used the drug on patients yet and thus refused to comment on its efficacy.
Eric Lattaman, vice president, research, PNB Vesper said,"PNB-001 has been found to be twenty times more efficacious than aspirin in the antipyretic and pain studies." He further added that it has shown promising results in lung inflammation and acute respiratory distress syndrome (ARDS).