Kochi, Feb 11 : PNB Vesper, a leading Kerala-based life sciences company, on Thursday announced that it has successfully completed the Phase 2 clinical trials of its proprietary drug PNB-001 (GPP-Baladol) on Covid-19 patients.
The company had received approval from the Drug Controller General of India (DCGI) to conduct the Phase 2 trial on patients with moderate Covid and on oxygen support in September 2020.
The clinical trial was initiated in November 2020 at the B.J. Government Medical College and Sassoon General Hospital, Pune, and the Victoria Medical College and Research Institute, Bengaluru.
The clinical trial report will now be submitted to the DCGI on February 22.
The trial, conducted on 40 patients, was designed in-line with the solidarity trial conducted by WHO and other international clinical trials.
The primary objective of the clinical trial was to evaluate the overall efficacy of the drug in terms of outcomes such as changes from the baseline in the ordinal scale and mortality by day 28.
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