Kerala-based pharmaceutical organization 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.
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.”