Pharmaceutical drug research company PNB Vesper Life Science has received approval from the Drug Controller General of India (DCGI) to conduct the Phase 2b clinical trial of its candidate drug PNB-001 (GPP-Baladol), a novel chemical entity that was being researched to treat small cell lung cancer, for treating COVID-19 patients.
The trials on 40 COVID-19 positive patients at BMJ Medical College, Pune will be completed in 60 days. These are moderate cases of COVID-19 and patients are on the oxygen support. The effect of PNB 001 will be compared with Dexamethasone, a popular steroid with anti-inflammatory properties now used in COVID-19 treatment. A larger study of approximately 350 COVID-19 patients will be enrolled across the country in six medical Colleges in the Phase 3 clinical trials, after reviewing the phase 2 clinical trial results and further regulatory permissions, said PN Balaram, CEO of PNB Vesper.
He said PNB-001, envisaged as a new chemical entity (NCE) in tablet form, was found safe in a Phase-1 clinical trial among 74 healthy subjects at low, medium and high doses. In the pre-clinical models, it was found to be highly effective in inflammation compared with steroids and 20 times effective than aspirin in controlling high fever and temperature. The molecule has already been patented by PNB Vesper in the US, Europe and rest of the world, he said.
"It has shown remarkable results in lung inflammation and ARDS (Acute Respiratory Distress Syndrome). In the Dengue virus studies, PNB 001 had reduced the mortality of animals significantly, almost 80 per cent than the control group," said Dr. Eric Lattmann, Vice President Research, PNB Vesper.
Balaram said the company has a molecule under development for the treatment of inflammatory pain, arthritis and inflammatory bowel disease, now in the phase 2 clinical trials. The results are expected by the end of this month. PNB-028 is another molecule in the phase 2A stage for the treatment of pancreatic and colon cancer. The Kochi based pure NCE research company, which has research operations in the UK, US and Germany, is also developing four more molecules in early stage discovery for various cancers and pain, he said.
India's leading drug maker Sun Pharmaceutical is currently conducting clinical trials of a plant-based drug, AQCH, to treat COVID-19 patients. Sun has been developing this drug to treat dengue for the last four years in collaboration with the Department of Biotechnology International Centre for Genetic Engineering and Biotechnology (DBT-ICGEB) and the Council of Scientific and Industrial Research (CSIR). One of the leading drug makers, Mankind Pharma also has collaborated with South Korean company Daewoong Pharmaceutical Co for conducting phase-I clinical trial of a novel formulation of Niclosamide for the treatment of COVID-19 patients in India.
Many Indian companies like Glenmark, Cipla, BDR Pharma and FDC are also selling 'repurposed' old known molecules like Favipiravir in the treatment of COVID-19. Recently, the WHO had said steroids like Dexamethasone are a good option to treat and save lives of severe COVID-19 patients.
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