Phase 2b Clinical Trial Of Covid-19 Drug 'Baladol' To Begin Next Week At Pune Hospital

After getting the approval of Drug Controller General of India (DCGI), Kochi-based Pharmaceutical company PNB Vesper Life Science is set to start the Phase 2b clinical trials of its novel Covid-19 drug PNB-001 (GPP-Baladol) on the patients suffering from the disease from next week, reports Economic Times.

The company had earlier on 11 September announced that it had received the approval from Indian drug regulator DGCI for the clinical trials of their drug on Covid-19 patients.

According to the PNB Vesper's chief executive officer (CEO) P N Balaram, the drug is capable of treating fever, body pain and lung infection - conditions normally associated with Covid-19.

He said the drug is the "first chemical entity" in the phase 2 clinical trial in the world, and if it works, Baladol will be a "miracle molecule".

The trial of the drug will be conducted on 40 moderate Covid-19 patients, who are on oxygen support, at Pune's BMJ Medical college.

Balaram said that the company plans to complete the whole phase-2 clinical trial within 60 days as the government is speeding up the approval process and recruiting patients may not be a big problem.

According to the company, Baladol was found to be extremely safe in a Phase 1 clinical trial thereby leading to subsequent Phase 2 and 3 trials. It was tested in 74 healthy subjects at low, medium and high doses over a course of period. In the pre-clinical models, and found to be highly effective in inflammation compared with steroids.

After the completion of the phase 2 trials, a larger population, approximately 350 patients will be enrolled across the country in six medical Colleges for the Phase 3 trials. The molecule has already been patented and the related Intellectual Property Rights (IPRs) have been secured in the US, Europe and rest of the world.