Leading Indian pharma 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) for testing in Covid-19 patients.

PN Balaram, CEO of PNB Vesper Life, claimed that PNB 001 may be the first New Chemical Entity in the world allowed for testing in 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.

Moderate patients selected

The study will be conducted in 40 Covid-19 positive patients at the BMJ Medical College, Pune, who are moderate patients on oxygen support. The effect of PNB 001 will be compared with dexamethasone, currently the most popular medicine in Covid-19 treatment in the world.

Balaram said that a larger population, approximately 350 Covid-19 patients, will be enrolled in six medical colleges in the phase-3 clinical trials post the phase-2 clinical trial results. The molecule has already been patented and Intellectual Property Rights secured by PNB Vesper in the US, Europe and rest of the world.

GPP Baladol (PNB-001) has been was found to be extremely safe in a phase 1 clinical trial with expected pharmacokinetics and pharmacodynamics leading to subsequent phase 2b/3 trials, Balaram said. It was tested in 74 healthy subjects at low, medium and high doses over a course of various periods.

USFDA expresses interest

In the pre-clinical models, it was found to be effective in inflammation compared with steroids. It was also found to be 20 times more potent than aspirin, the gold standard for pyrexia studies. Further, according to Balaram, the US FDA has shown interest in the drug and the discussions with it are in the final stages.

Other than this, discussions have also 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 Eric Lattmann, is coordinating the UK developments. Lattmann is Vice-President, Research, at PNB Vesper.

“PNB-001 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 per than the control group. Also, cytokine storms and spleen size reduced significantly. This means the mortality rate can be reduced considerably,” Lattmann said.

Better results expected

Balaram said considering the novel mechanism of the molecule, the company expects 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 patients are lost mainly because of cytokine Storms and ARDS.

“Pre-clinical studies of 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, which could lead to the manufacturing of the drug,” he added.

PNB 001 is further found to have been very 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,” Balaram said.