Kochi firm gets nod to test India's first novel molecule for Covid-19

PNB Vesper's drug developed from 12 years of research for small-cell lung cancer (for which it is under trial) has shown positive response in Covid-19, the firm claims

A new drug (or a novel chemical entity, or NCE) to treat Covid-19, developed by a Kochi-based firm, can hit the market in six months.

PNB Vesper, a research-based organisation, has got the nod from the country’s drug regulator to conduct phase 2b trials of its candidate code-named PNB-001. 

This would be India’s first NCE to treat Covid-19 if it gets marketing approval. Globally, drug majors like Merck are developing drugs for the Sars-CoV-2 virus and some of these global candidates have shown promise.

Drugs like remdesivir and favipiravir, along with steroids and other anti-inflammatory drugs, are commonly used now as off label therapies.

PNB Vesper’s drug, developed from 12 years of research by the firm for small cell lung cancer (it is under trial for that), has shown a positive response in Covid-19, the firm said.

What’s more, the drug may also have prophylactic properties -- that is if one takes a specified dosage, it may help to prevent getting a Covid-19 infection.

The company will conduct a study on 40 Covid-19 patients at BMJ Medical College in Pune and it will be completed in 60 days.

It has identified six centres in India for phase 3 trials (over 350 patients) and that should take three-four months. If things go according to plan, the drug would be ready to hit the market (subject to regulator approval) by March, said P N Balaram, chief executive officer, PNB Vesper Life. 

PNB-001 helps to reduce the cytokine release syndrome (the abnormal reaction of the body’s immune system that causes inflammatory cytokine release) and can also be administered orally.

“It will be in capsule form,” Balaram said. The other drugs being currently used to reduce cytokine release in the blood – Roche’s tocilizumab and Biocon’s itolizumab – are both injectables and thus need a hospital setting for administration.

Does this molecule neutralise the virus? PNB Vesper says not really. It does not reduce the viral load, but acts on the other common symptoms caused by the virus.

In the clinical trials, PNB-001 will be compared to a common inexpensive steroid dexamethasone, which is being given to Covid-19 patients who need oxygen support. The Kochi firm has patented the molecule in India, the US, the EU, and the 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 many patients might not require any other drug because this molecule had multiple benefits.

“In Covid-19, the main symptoms are pyrexia (fever), body pain, and inflammation in the lung and we lose patients mainly because of cytokine storms and acute respiratory distress syndrome (ARDS). We have proved in pre-clinical studies our drug is effective in reducing fever, body pain, and inflammation,” he said.

Eric Lattaman, vice-president (research), PNB Vesper, said: “PNB-001 has been found to be 20 times more efficacious than aspirin in the antipyretic and pain studies.” He added it had shown promising results in lung inflammation and ARDS.  

Clinicians Business Standard contacted have not used the drug on patients yet and refused to comment on its efficacy. However, Satyanarayana Mysore, head of the Department of Interventional Pulmonology, Manipal Hospitals, pointed out some key aspects that needed to be kept in mind before use.

“We need to see the justification (in terms of added benefits) a new molecule has over conventional steroids, which are also inexpensive,” he said.

Steroids have some side-effects, but dexamethasone is an affordable drug -- about Rs 10 per injectable dose.