New COVID-19 drug gets DCGI's nod for human trial
The drug has shown positive results in all the initial preclinical studies
Amid the raging coronavirus pandemic, PNB Vesper Life Science Private Limited on Friday received approval from the Drug Controller General of India to conduct the clinical trial of their drug on Covid-19 patients.
Speaking to IANS about the breakthrough innovation, CEO of PNB Vesper Life Science Private Limited P.N. Balaram said that this is a very big step for mankind in the fight against the Covid-19 pandemic. The molecule has shown remarkable results in reducing lung inflammation and acute respiratory distress syndrome.
The Indian Pharma Research company claimed that if their propriety drug PNB-001 -- Baladol -- works successfully in Covid-19 patients, it would be the "first new chemical entity in the world for treatment of the disease".
The drug has shown positive results in all the initial preclinical studies. The Phase 2, which would prove the efficacy of the molecule, will now be conducted at BMJ Medical College in Pune on 40 moderate patients on oxygen support, within 60 days.
"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," said CEO Balram.
He said that with the drug, the death rate also reduced to 80 percent, whereas Dexamethasone drug, currently the most popular medicine in COVID-19 treatment in the world, only gives 20 per cent death reduction.
"Considering the novel mechanism of our molecule we expect much better results in the clinical trials compared with Dexamethasone. It means the mortality rate can be reduced considerably by using Baladol," the CEO said.
According to the company, Baladol was found to be extremely safe in the Phase 1 clinical trial thereby leading to subsequent Phase 2 and 3 trials. It was tested in 74 healthy subjects at low, medium and high doses over a course of a period. In the pre-clinical models, and found to be highly effective in inflammation compared with steroids.
After the completion of the phase 2 trials, a larger population, approximately 350 patients will be enrolled across the country in six medical Colleges for the Phase 3 trials. The molecule has already been patented and the related Intellectual Property Rights (IPRs) have been secured in the US, Europe and the rest of the world.
Further, the US FDA has shown interest in the drug and the discussions with USFDA are in the final stages. Other than this, discussions have already been initiated with the UK Government to include the drug in the ongoing Covid-19 clinical trials. PNB Vesper's UK Scientific Team headed by Eric Lattmann is coordinating the UK developments.
"PNB-001 has been found to be twenty times more efficacious than aspirin in the antipyretic and pain studies. It is also proved that the cytokine storms and spleen size reduced significantly," Lattmann said.
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