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PNB Vesper, a leading Kerala-based life sciences company received permission from the DCGI and entering into the final phase 3 clinical trials. After a detailed deliberation by the Subject Expert Committee (SEC) on the phase 2 clinical trial results of PNB001 (GPP-Balacovin), the company has now been given a green signal to conduct a nationwide multi-centered phase 3 clinical trial on hospitalized 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 d that possesses significant efficacy to save the hospitalized patients with oxygen support, from the deadly coronavirus.
The phase 2 clinical trial results are published in MEDRXIV, a preprint journal published by BMJ (British Medical Journal) and Yale University.
PNB-001 (GPP-Balacovin), a new chemical entity, is a first-in-class cholecystokinin-A (CCK-A) agonist and CCK-B antagonist. Most of the anti-inflammatory drugs available in the market for the treatment of Covid-19 are immunosuppressants having lot of side effects. Excessive and inappropriate use of the anti-inflammatory drugs like steroids can lead to secondary infections like black fungus or bacterial infections in immunocompromised Covid-19 patients.
The company stated, “GPP-Balacovin is the only known molecule in the world that acts as a powerful anti-inflammatory agent with immuno modulation properties. This unique feature helps the molecule to bring the outof-tune immune system back to normal and control the aggressive inflammatory response in the body also known as cytokine storm caused by Covid-19 infection.”
PNB Vesper had initiated the phase 2b clinical trial in October 2020 at BJ Government Medical College, Sassoon General Hospital Pune, and Victoria Hospital attached to the Bangalore Medical College and Research Institute, Bengaluru. The clinical trial protocol was designed in line with the solidarity trial conducted by WHO and other international trials.
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. Further GPP- Balacovin group also noticed a 50% less fatality rate compared to the standard of care group. Another major observation was found in the level of one of the prominent immunological markers ‘IL-6’ in the plasma of Covid-19 patients.
Speaking on the breakthrough innovation, P N Balaram, CEO, PNB Vesper Life Sciences said, “We are more than happy and proud to say that we have successfully developed a new chemical entity to treat Covid-19 and have received approval from DCGI for phase 3 clinical trials. This is a promising drug for Covid-19 patients globally, who are hospitalized with oxygen support. The drug is explicitly non-toxic to humans as evidenced in phase 1 and in phase 2 clinical trials. This is indeed a very big step for mankind in its fight against the Covid-19 pandemic.
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 innovative. The parameters evaluated in the clinical trial clearly indicates the potential of the drug in treating Covid-19 patients. The results of the clinical trial clearly 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.
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