GPP-Baladol, a novel chemical entity (NCE) being developed by pharmaceutical research firm PNB Vesper Life Science for treating Covid-19 patients, claims to have shown promising results in the Phase 2b clinical trials. The pharma firm will soon seek Indian drug regulators' approval for emergency use in the country.
The trial was conducted on 40 patients since November at BJ Government Medical College and Sassoon General Hospital Pune and Victoria Medical College and Research Institute, Bangalore. The clinical trial report will be submitted to the DCGI today seeking for an 'Emergency Use Authorisation' to treat hospitalised patients in the country in a clinical trial mode, said PNB Wesper, a Kochi-based pure NCE research firm with research operations in the UK, US and Germany.
"After knowing the efficacy of the drug in Covid-19 treatment, we are hoping to get immediate approval from the government to make the drug readily available for use in treatment of the hospitalised patients. Discussions are also started with the US and UK governments on the same front," said P N Balaram, CEO, PNB Vesper Life Sciences.
Most patients treated with GPP-Baladol showed significant clinical improvement in the early days of treatment, and none reported any post-treatment health risks. There are about 28 post-covid long-term complications identified by WHO. The patients treated with the drug do not have any such long-term health risks and are feeling healthy, he said.
In September, PNB Vesper Life Science had received approval from the Drug Controller General of India (DCGI) to conduct the Phase 2b clinical trial of 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 performance of GPP-Baladol is much superior when compared to the current COVID-19 treatment paradigm. The parameters evaluated in the clinical trial clearly indicate the potential of the drug in treating COVID-19 patients and the results indicate that GPP-Baladol can be a better therapeutic option for treating patients with severe lung lesions," said Dr. Eric Lattman, Vice President, PNB Vesper Life Sciences.
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.
The company also has a molecule under development for the treatment of inflammatory pain, arthritis and inflammatory bowel disease, now in the phase 2 clinical trials. PNB-028 is another molecule in the phase 2A stage for the treatment of pancreatic and colon cancer. PNB Wesper is also developing four more molecules in early stage discovery for various cancers and pain.