Leading Indian pharmaceutical research company PNB Vesper Life Science has received required permissions from India’s Drug Controller General of India (DCGA) to conduct the clinical trial of their drug on COVID-19 patients.
Mr. P.N. Balaram, CEO of the firm touted the drug as a breakthrough innovation stating it as a very big step for mankind in the fight against the pandemic.
He added that the molecule in his firm’s drug has shown remarkable results in reducing lung inflammation and acute respiratory distress syndrome. If successful, their propriety drug “PNB-001- Baladol” would be the “first new chemical entity in the world for the treatment of the disease”.
Initial pre-clinical results
The drug has shown positive results in all the initial preclinical studies. Phase 2, which would prove the efficacy of the molecule, will now be conducted at BMJ Medical College in Pune on 40 moderate patients on oxygen support, within 60 days.
“In Covid-19, the main symptoms are pyrexia, body pain and inflammation in the lung and we lose patients mainly because of cytokine storms and ARDS. We have proved in the pre-clinical studies, our drug is effective in reducing fever, body pain and inflammation.”
Mr. Balram remarked that the drug’s usage reduced the death rate to 80 percent, whereas the most popular medicine in COVID-19 treatment in the world Dexamethasone only gives 20 percent death reduction.
“Considering the novel mechanism of our molecule, we expect much better results in the clinical trials compared with Dexamethasone. It means the mortality rate can be reduced considerably by using Baladol,” the CEO said.
Phase 1 Trials
Baladol was found to be extremely safe in 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 the 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 the rest of the world.
The US FDA has shown interest in the drug and the discussions with US authorities are in the final stages. Discussions have already been initiated with the UK Government to include the drug in the ongoing COVID-19 clinical trials.
PNB Vesper’s UK Scientific Team headed by Eric Lattmann is coordinating the UK developments. “PNB-001 has been found to be twenty times more efficacious than aspirin in the antipyretic and pain studies. It is also proved that the cytokine storms and spleen size reduced significantly,” Mr. Lattmann said.