PNB Vesper has received permission from the Drugs Controller General of India (DCGI) to enter into the phase-III clinical trials of PNB 001/GPP-BALACOVIN, the company said in a statement.
After a detailed deliberation by the Subject Expert Committee (SEC) on the phase-II clinical trial results of PNB – 001 (GPP-BALACOVIN), the company has now been given a green signal to conduct a nation-wide multi-centered phase-III clinical trial on hospitalised COVID-19 patients with oxygen support. The phase-III 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 coronavirus, it added.
It also informed that the phase-II clinical trial results are published in Medrxiv, a pre-print journal
published by British Medical Journal (BMJ) 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 a 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 immuno-compromised COVID-19 patients” it said.
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 out-of-tune immune system back to normal and control the aggressive inflammatory response in the body also known as cytokine storm caused by the COVID-19 infection. Cytokine storm aggravates ARDS and causes tissue damage leading to multiple organ failure, and unfavorably affect the prognosis of severe COVID-19 leading to mortality,” the statement further mentioned.
Speaking in this regard, PN 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 to conduct the phase-III clinical trials. This is a promising drug for COVID-19 patients around the world. 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 the World Health Organization (WHO), and our treated group does not pose any such long-term health risks, and is feeling healthy compared to the standard arm.”