12 February 2021 | News
The clinical trial report will now be submitted to DCGI on February 22, 2021
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PNB Vesper, a leading Kerala based life sciences company, has 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 Clinical trial of GPP-BALADOL in COVID-19 moderate patients with oxygen support in September 2020.
The clinical trial was initiated in November 2020 at BJ Government Medical College and Sassoon General Hospital Pune, and Victoria Medical College and Research Institute, Bengaluru. The clinical trial report will now be submitted to DCGI on February 22, 2021.
The trial was conducted on 40 patients. The clinical trial protocol was designed in-line with the solidarity trial conducted by WHO and other international clinical trials. In order to assess this effectiveness, the patients were divided into two groups and both groups were provided the standard of care described in the Clinical Management Protocol of the Ministry of Health & Family Welfare (MoHFW), in-line with WHO protocol. The other group, in addition to the standard of care, was given GPP-Baladol thrice a day at a dose of 100 milligrams.
Speaking on the breakthrough innovation, PN Balaram, CEO, PNB Vesper Life Sciences Pvt Ltd said, “Considering the novel mechanism of action of the drug and the clinical trial outcome, GPP-Baladol can be a possible option to save the hospitalised patients all over the world.”
Dr Eric Lattman, Vice President, PNB Vesper Life Sciences said, “The parameters evaluated in the clinical trial clearly indicate the potential of the drug in treating COVID-19 patients and the results indicate that GPP-Baladol can be a better therapeutic option for treating patients with severe lung lesions.”