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.