PNB 001/ GPP-BALACOVIN is proving to be a breakthrough in COVID-19 treatment
Kerala-based PNB Vesper has received DCGI permission to conduct the final phase 3 clinical trials. After a detailed deliberation by the Subject Expert Committee (SEC) on the Phase 2 Clinical Trial results of PNB-001 (GPP-BALACOVIN), the company has now been given a green signal to conduct a nationwide multi-centred Phase 3 Clinical Trial on hospitalised COVID-19 patients with oxygen support.
The Phase 3 trial will be conducted on a large patient population in 12 hospitals all over India. GPP- BALACOVIN is a novel and safe drug that possesses significant efficacy to save the hospitalised patients with oxygen support, from the deadly coronavirus.
PNB Vesper had initiated the phase 2b 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 BALACOVIN 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- BALACOVIN three times a day.
The patients who were given GPP- BALACOVIN 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- BALACOVIN achieved WHO Ordinal Scale score of zero, whereas only 71 per cent achieved WHO Ordinal Scale score of zero on day 15.
Speaking on the breakthrough innovation, PN Balaram, CEO, PNB Vesper Life Sciences said, “We are happy that we have successfully developed a New Chemical Entity to treat COVID-19 and have received approval from DCGI to conduct the Phase 3 Clinical trials. This is a 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 and Phase 2 clinical trials. None of the patients treated with GPP- BALACOVIN 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- BALACOVIN is much superior over the current treatment paradigm. The mechanism of action of the drug is unique and innovative. The parameters evaluated in the clinical trial indicates the potential of the drug in treating COVID-19 patients. The results of the clinical trial indicate that GPP- BALACOVIN was found to be a turbo anti-inflammatory molecule with immuno-modulation properties. This breakthrough feature of GPP- BALACOVIN can help in the treatment of several acute inflammatory and auto-immune diseases and cancer treatments in the future.”