Kochi: Kerala-based life sciences companu PNB Vesper on Friday announced that it has successfully completed phase 2 clinical trials of its proprietary drug PNB-001 (GPP-Baladol) on COVID-19 patients. The development comes after the company received approval from the Drug Controller General of India (DCGI) to conduct phase 2 clinical trial of GPP-BALADOL on COVID-19 moderate patients last year itself.
PNB Vesper received the go-ahead to conduct phase 2 trials last September itself, and it was initiated in November 2020 at the BJ Government Medical College and the Sassoon General Hospital in Pune, and the Victoria Medical College and Research Institute in Bangalore. The clinical trial report will now be submitted to the DCGI on February 22, said a statement from the company on Friday.
According to a press reelase from PNB Vesper, the trial was conducted on 40 COVID-19 patients. “The clinical trial protocol was designed in-line with the Solidarity Trial conducted by WHO (World Health Organization) 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,” it added.
The secondary objective, according to PNB Vesper, was to evaluate the safety of GPP-Baladol in patients with moderate COVID-19 infection in terms of outcomes, such as improvement in inflammatory segments in X-ray, duration of hospital stay, duration of assisted ventilation, improvement in oxygen saturation, etc.
In order to assess the effectiveness of the drug, the patients were divided into two groups and both groups were provided the standard of care prescirbed to the clinical management protocol of the Ministry of Health & Family Welfare (MoHFW) and the WHO. The other group, in addition to the standard of care, was given GPP-Baladol thrice a day at a dose of 100 milligrams, said PNB Vesper.
“This is indeed a very big step for mankind in its fight against the COVID-19 pandemic. We are really happy and proud to announce the results to the world. Considering the novel mechanism of action of the drug and the clinical trial outcome, GPP-Baladol can be a possible option to save the hospitalized patients all over the world. So far, most of the patients treated with GPP-Baladol showed significant clinical improvement even in the early days of their treatment.
PNB Vesper is a research-based bio-pharmaceutical organization that is determined to discover drugs for serious diseases. The company claimed that it is currently only one of very few companies in India that is focused only on research-based NCEs, rather than generics.