KOCHI: PNB Vesper Life Science Pvt Ltd, a Kochi-based pharma research company, has received approval from the Drugs Controller General of India (DCGI) to conduct the Phase 2b clinical trial of its proprietary drug PNB-0001, named GPP-Baladol, among Covid-19 patients.PNB Vesper Life managing director P N Balaram claimed the drug could be the first new chemical entity in the world to be tested without vaccination in Covid-19 patients.
“The company has filed the clinical trial application with the DCGI and the study will be completed within 60 days. It will be conducted on 40 Covid-19 positive patients at BMJ Medical College in Pune, who are moderate patients on oxygen support,” he said. The results will be compared with dexamethasone, currently the most popular medicine in Covid treatment across the world. Around 350 Covid-19 patients in six medical colleges will be enrolled across the country for Phase 3 clinical trials after reviewing phase 2 results.
“The molecule has already been patented and the related Intellectual Property Rights have been secured by PNB Vesper in the US, Europe and rest of the world,” said Balaram.The Phase 1 clinical trial was conducted among 74 subjects at low, medium and high doses at Lambda Clinical Research Ltd in Ahmedabad.In the pre-clinical models, the molecule was found to be highly effective in inflammation compared with steroids. It was also found to be 20 times more potent than aspirin.
The US FDA has shown interest in the drug and discussions are in the final stage. Discussions have been initiated with the UK Government to include the molecule in the ongoing Covid-19 clinical trials, he said.
“In the pre-clinical studies, our drug was found to be effective in reducing fever, body pain and inflammation. Baladol has shown positive results in all the initial pre-clinical studies and we hope that the final trials will prove the efficacy of the molecule in Covid-19 patients. There is every possibility of success in the clinical trial and we are confident of going into production in five months,” said Balaram.
PNB Vesper vice-president Dr Eric Lattmann said the molecule has shown remarkable results in lung inflammation and Acute Respiratory Distress Syndrome. “In the dengue virus viremia model studies, the molecule reduced the mortality of animals significantly, almost 80 per cent than the control group. It is also proved that cytokine storms and spleen size reduced significantly. This means, the mortality rate can be reduced considerably by using GPP Baladol,” he said.