A Covid-19 drug manufactured by Kerala-based company, PNB Vesper, has received nod by DCGI to conduct Phase 3 clinical trials. The company will be conducting a nationwide multi-centred clinical trial of the drug- PNB-001 (GPP-BALACOVIN), on Covid-19 patients who are hospitalised and are on oxygen support. The trial is expected to be conducted among a large patient population in over 12 hospitals across India.
The company has claimed that the drug, GPP- BALACOVIN is safe to use and has significant efficacy when it comes to saving the Covid-19 hospitalised patients with oxygen support. According to PN Balaram, CEO, PNB Vesper Life Sciences said, the drug can be promising for COVID-19 patients across the world. He explained that it is “explicitly non-toxic to humans” as shown in the first two phases of human clinical trials. “After the treatment with the drug, none of the patients reported any post-treatment health risks,” said Balaram.
It is to note that there are 28 post-covid long-term complications that the WHO has identified. And the results of clinical trials have shown that patients who were administered the Covid-19 drug did not have any long-term health risk when compared to those who received standard treatment, PNB Vesper said in a press note. Dr Eric Lattman, Vice President, PNB Vesper highlighted that the performance of the drug is much superior over the current treatment paradigm.
To be sure, in Covid-19 cases, patients are usually at risk with getting back fungus infection because of immunosuppressants and if immunosuppressants are not monitored, patients can have an aggressive inflammatory response- cytokine storm. The company said that the drug has been modulated in a way that can act as a powerful anti-inflammatory agent with immuno modulation properties.
It was found that the turbo anti-inflammatory molecule along with immuno-modulation properties can be quite helpful in the treatment of many acute inflammatory and auto-immune diseases along with cancer treatments as well in the future, added Dr Lattman.
Meanwhile, the results of the first two phases of clinical trials have been published in a pre-journal by British Medical Journal(BMJ) and Yale university.