PNB Vesper to commence phase II clinical trial of COVID-19 drug in BJ Medical College, Pune
The company has already patented the molecule and secured intellectual property rights in the US, Europe and rest of the world
PNB Vesper Life Science is set to begin the phase II clinical trial of its COVID-19 treatment drug PNB-001 (GPP-Baladol) at BJ Medical College and Sassoon General Hospital, Pune.
To begin with the phase II clinical trial, it has identified the first patient with COVID-19 pneumonia and breathing problems, who will be administered with GPP-Baladol on October 24 at BJ Medical College, Sassoon. The study will be conducted in 40 COVID-19 positive patients in the same institute and the principal investigator of the study is Dr Pradnya Bhalerao, Head, COVID-19 Department, BJ Medical College. A group of doctors from the US, UK and India will be monitoring the studies on a daily basis. The study is likely to be completed in 60 days and the interim efficacy results will be released within 30 days.
Commenting on the development, P N Balaram, CEO, PNB Vesper Life Science said, “This is indeed a very big step for mankind in its fight against the COVID-19 pandemic. The clinical trials would be completed in 60 days. Considering the novel mechanism of our molecule, we expect better results in the clinical trials, compared with dexamethasone. 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. PNB 001 is found to be effective against all COVID-19 symptoms. PNB 001 is further found to be very effective in small cell lung cancer. If the molecule is found to work successfully in COVID-19 patients, PNB 001 may be the first New Chemical Entity in the world for the COVID-19 treatment.”
The effect of PNB 001 will be compared with dexamethasone, which is also used for the medication of COVID-19 treatment. The company has already patented the molecule and its related Intellectual Property Rights (IPRs) have been secured by PNB VESPER in the US, Europe and the rest of the world.
During the phase I clinical trials of GPP Baladol (PNB-001) it was tested in 74 healthy humans and found safe. Last month, the company has received the approval from the Drug Controller General of India (DCGI) to conduct the phase-2b clinical trial of its propriety drug PNB-001 (GPP-Baladol) for testing in COVID-19 patients.
Based on the phase II report, the company aims to conduct the phase III clinical trial of GPP- Baladol on a larger population, which would be approximately 350 COVID-19 patients across the country in six different medical colleges.