Submits report to DCGI and Government of India for Emergency Use Authorisation
Kerala-based life sciences company PNB Vesper announced that it has successfully completed the COVID-19 Phase 2 Clinical Trials and submitted the final report of its proprietary drug PNB-001 (GPP-Baladol) to the Drug Controller General of India (DCGI). GPP-Baladol is a novel and safe medicine that possesses significant efficacy to save the COVID-19 hospitalised patients with oxygen support, from the deadly coronavirus. PNB Vesper has approached the DCGI and the Government of India for an Emergency Use Authorisation of the drug for COVID-19 hospitalised patients.
PNB Vesper had initiated the clinical trial in October 2020 at BJ Government Medical College, Sassoon General Hospital Pune, and Victoria Medical College and Research Institute, Bangalore. The clinical trial protocol was designed in line with the Solidarity Trial conducted by WHO and other international 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.
As part of the clinical trial, patients were divided into two groups in which one group received the WHO specified Standard of Care treatment and the other group received the Standard of Care treatment along with a 100 mg capsule of GPP-Baladol three times a day.
The patients who were given GPP-Baladol showed significant improvement in the ordinal scale for clinical improvement proposed by WHO right from day five of the treatment. On day 15, at the end of the treatment, 94 per cent of the patients treated with GPP-Baladol achieved a WHO Ordinal Scale score of zero, whereas only 71 per cent achieved a WHO Ordinal Scale score of zero on day 15. WHO Ordinal Scale score of zero indicates no clinical evidence of Covid-19 infection. This improvement noted in the ordinal scale for clinical improvement in the GPP-Baladol group is better than several similar clinical trials conducted in COVID-19 patients with Repurposed Medications in various countries. GPP-Baladol group also noticed a 50 per cent less death rate compared to the Standard of Care group.
The chest X-rays also showed characteristic radiographic findings in COVID-19 patients. On day 15, in the clinical trial, 50 per cent of the patients of the GPP-Baladol treated group showed complete improvement in the chest X-ray, whereas, on day 15, the improvement in the chest X-ray was observed in the standard of care group was only 37 per cent. On day 14, in the GPP-Baladol group, 94 per cent of patients were off oxygen support, whereas, on day 14, only 76 per cent of patients were off oxygen support in the standard of care group. The patients treated with GPP-Baladol were hospitalized for fewer days compared to the standard of care patients.
Another major observation was found in the level of one of the prominent immunological markers ‘IL-6’ in the plasma of COVID-19 patients. In the group treated with GPP-Baladol, there was a drastic decrease in IL-6 compared to the baseline value by 74 per cent, whereas in the patients under the standard of care treatment, the decrease in IL-6 was only 62 per cent. Increased levels of IL-6 signifies a higher risk of respiratory failure.
In COVID-19 patients, lymphocytes present in the blood also get diminished. This decrease in lymphocytes is a prognostic marker in covid-19 and is also correlated with IL-6. The increase in lymphocyte count was much higher in the patients treated with GPP-Baladol (about 83 per cent), compared to the patients under the standard of care alone (about 41 per cent).
The increase in the level of inflammatory marker ’C-Reactive Protein’ (CRP) in COVID-19 patients indicates injury to the vital organs. The decrease in CRP observed in the patients treated with GPP-Baladol is higher (93 per cent) compared to the standard of care group (65 per cent), which reconfirms the significant anti-inflammatory effect of GPP-Baladol against COVID-19 onslaught.
It is a common observation that in COVID-19 patients, the neutrophil-to-lymphocyte ratio increases. On treatment with GPP-Baladol for 14 days, 85 per cent of patients who had a neutrophil-to-lymphocyte ratio greater than 4.7 at the time of admission, recovered faster. In the standard of care group, recovery in the neutrophil-to-lymphocyte ratio was seen only in 53 per cent of patients. Due to the increased inflammatory processes, the platelet-to-lymphocyte ratio elevates in the COVID-19 patients. The decrease in platelet-to-lymphocyte ratio observed in the GPP-Baladol treated patients was 63 per cent, which was greater than the other group (52 per cent).
Speaking on the breakthrough innovation, PN Balaram, CEO, PNB Vesper Life Sciences said, “We are happy and proud to say that we have successfully developed a molecule to treat COVID-19 and submitted the final report to DCGI and the Government of India. GPP-Baladol is a very promising drug for Covid-19 patients around the world, who are hospitalised with oxygen support. The drug is explicitly non-toxic to humans as evidenced in Phase 1 clinical Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) trials conducted and in Phase 2 clinical trials. This is indeed a very big step for mankind in its fight against the COVID-19 pandemic. 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 does not pose any such long-term health risks and is feeling healthy compared to the standard arm.
Dr Eric Lattman, Vice President, PNB Vesper said, “The performance of GPP-Baladol is much superior over the current treatment paradigm. The parameters evaluated in the clinical trial clearly indicate the potential of the drug in treating COVID-19 patients. The results of the clinical trial clearly indicate that GPP-Baladol was found to be a turbo anti-inflammatory molecule with immuno-modulation properties. This feature of GPP-Baladol can help in the treatment of several acute inflammatories and auto-immune diseases in the future.”