The clinical trial report will be submitted to Drug Controller General of India on February 22, 2021
Kerala-based PNB Vesper Life Sciences has 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, Bangalore. The clinical trial report will 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. 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.
The secondary objective 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, number of days for a negative PCR result and change in inflammatory markers from baseline.
The safety of GPP-Baladol was assessed by the adverse effects shown by the patients and based on functional blood chemistry analysis for liver and kidney and other vital parameters. To assess the effectiveness, the patients were divided into two groups and both groups were provided with the standard of care described in the Clinical Management Protocol of the Ministry of Health & Family Welfare (MoH&FW), in-line with the 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 said, “This is indeed a very big step for mankind in its fight against the COVID-19 pandemic. Considering the novel mechanism of action of the drug and the clinical trial outcome, GPP-Baladol can be a possible option to save hospitalised 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. Also, none of the patients treated with GPP-Baladol reported any post-treatment health risks. There are about 28 post-covid long-term complications identified by WHO and our treated group do not pose any such long-term health risks and are feeling healthy compared to the standard arm. We are approaching the Government of India for an Emergency Use Authorisation of our drug to treat the hospitalised patients in the country in a clinical trial mode. After knowing the efficacy of the drug in COVID-19 treatment, we are hoping to get immediate approval from the government to make the drug readily available for use in the treatment of hospitalised patients. Discussions are also started with the US and UK governments on the same front.”
Dr Eric Lattman, Vice President, PNB Vesper Life Sciences, said, “The performance of GPP-Baladol is much superior when compared to the current COVID-19 treatment paradigm. The parameters evaluated in the clinical trial 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”.
