PNB Vesper, a Kochi-based life sciences company, on September 11 said it has received approval from the Drugs Controller General of India (DCGI) to conduct the Phase 2b clinical trial of their propriety drug PNB-001 (GPP-Baladol) on COVID-19 patients.
The company has filed the clinical trial application with the DCGI for the Phase 2 clinical trials, and the study will be completed in 60 days. The study will be conducted on 40 Covid-19 positive patients, who are moderate patients on oxygen support, at BMJ Medical College, Pune.
The effect of PNB-001 will be compared with dexamethasone, currently the most popular medicine in Covid-19 treatment in the world.
A larger population, 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, the life science start-up said.
The molecule has already been patented and the related Intellectual Property Rights (IPRs) have been secured by PNB Vesper in the US, Europe and rest of the world.
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GPP-Baladol was found extremely safe in phase-1 clinical trials leading to subsequent phase 2b/3 trials, PNB Vesper said.
In phase-1, it was tested on 74 healthy subjects at low, medium and high doses over a course of various periods.
In the pre-clinical models, the company said, PNB-001 was found to be highly effective in inflammation compared with steroids. It was also found that PNB-001 is 20 times more potent than Aspirin which is the gold standard for pyrexia (fever) studies.
US, UK clinical trials
Further, the US FDA has shown interest in the drug and the talks are in the final stages. Other than this, discussions have already been initiated with the UK government to include PNB-001 in the ongoing COVID 19 clinical trials.
PNB Vesper’s UK scientific team headed by Dr. Eric Lattmann is coordinating the UK developments.
“Considering the novel mechanism of our molecule, we expect much better results in the clinical trials compared with dexamethasone,” said PN Balaram, chief executive of PNB Vesper.
“In COVID-19, the main symptoms are Pyrexia (fever), body pain and inflammation in the lungs, and we lose patients mainly because of Cytokine Storms and ARDS. We have proved in the pre-clinical studies our drug is effective in reducing fever, body pain and inflammation. GPP – Baladol has shown positive results in all the initial pre-clinical studies, and we do hope that the final trials would prove the efficacy of the molecule in COVID-19 patients, which could lead to the manufacturing of the drug,” Balaram added.
Balaram claimed that GPP-Baladol has also been found effective in Small Cell Lung Cancer Xenograft and Allograft studies.
“PNB-001 has been found to be 20 times more efficacious than Aspirin in the Antipyretic and Pain Studies. It has shown remarkable results in lung inflammation and ARDS (Acute Respiratory Distress Syndrome),” said Dr. Eric Lattmann, vice president research, PNB Vesper.
“In the Dengue Virus Viremia Model studies, PNB-001 reduced the mortality of animals significantly, almost 80 percent than the control group. It is also proved that the cytokine storms and spleen size reduced significantly. This means the mortality rate can be reduced considerably by using GPP-Baladol,” Lattmann added.PNB Vesper, founded in 2011, has 6 molecules in various development stages targeting pain and various cancers.