PNB Vesper Life Science gets approval to test world’s first NCE to treat COVID-19 in Indian patientsSeptember 12, 2020 0 By FM
The Kochi-based drug research company PNB Vesper Life Science has received approval from the Drug Controller General of India (DCGI) to conduct Phase-2b clinical trial of its propriety drug PNB-001 (GPP-Baladol)— a new chemical entity, for testing in moderate COVID-19 patients in India. The testing will be done in 40 Covid-19 patients, who are on oxygen support, at BMJ Medical College- Pune, and will be completed in 60 days.
PNB001 is an anti-inflammatory analgesic drug molecule that has the potential to reduce the cytokine storm by a dual mechanism of action compared to corticosteroids. In the Phase 2 trial, the effect of PNB 001 will be compared with dexamethasone, which is a corticosteroid used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects and had shown efficacy in reducing the symptoms of COVID-19 patients.
“PNB-001 has an action on the inflammatory cytokines by the cholinergic anti-inflammatory pathway and the Gastrin- releasing peptide (GRP) receptor pathway. It has a potential to reduce the pro-inflammatory cytokines, and in turn, the cytokine storm which is the main cause of fatalities in COVID-19 patients,” said P N Balaram, CEO of PNB Vesper Life Pvt Ltd, in an interview with Future Medicine.
“It is a CCK antagonist which is not an immunosuppressant like other available treatments and this is the exclusivity of this molecule by dual-action through two pathways,” he added.
PNB-001 has been tested in Phase-I safety/ tolerability, pharmacokinetics and pharmacodynamics (SAD and MAD) studies at Lambda Therapeutics Ahmedabad and the results demonstrated the drug was safe with excellent plasma concentrations, according to the company.
It was tested in 74 healthy subjects at low, medium and high doses over a course of various periods. In the pre-clinical models, PNB-001 was found to be highly effective in inflammation compared with steroids.
The other indications where PNB001, which has already been patented by PNB VESPER in the US, Europe and the rest of the world, has been studied include inflammatory bowel disease, dysmenorrhoea and small cell lung cancer.
Highlighting the key findings of PNB – 001 trial, Dr. Eric Lattmann, Vice President Research PNB VESPER said, “PNB-001 has been found to be twenty 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). In the Dengue Virus Viremia Model studies, PNB 001 reduced the mortality of animals significantly, almost 80% 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 PNB001”.
Speaking on the breakthrough innovation, P N Balaram said that considering the novel mechanism of our molecule, the company expect much better results in the clinical trials compared with dexamethasone.
“In COVID-19, the main symptoms are pyrexia, body pain and inflammation in the lung 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. PNB001 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,” he said.
“PNB 001 is also found to be effective in small cell lung cancer xenograft and allograft studies too. If the molecule is found to work successfully in Covid-19 patients, PNB 001 may be the first new Chemical Entity in the world for COVID-19 treatment.” Added Balram.
After reviewing the results from the phase-2 clinical trial the company would further enrol a larger population, involving approximately 350 Covid-19 patients across the country in 6 medical colleges for the Phase 3 clinical trials.
The company said on Friday that the 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 will be coordinating the UK developments.