PNB Vesper has developed a new drug (Novel Chemical Entity or NCE), code-named PNB-001 (GPP-Baladol®) to treat COVID-19, and will apparently hit the markets in 6 months. If the tests are successful, PNB-001 will be India’s first NCE to treat COVID-19.
The phase 2 clinical trials will be completed in 60 days and will be conducted on 40 COVID-19 patients, who are on moderate Oxygen support, at the BMJ Medical College, Pune. The results will be compared with Dexamethasone, the most popular medicine for COVID-19 treatment at present. After reviewing the results of phase 2 trials, phase 3 trials will be conducted across 6 medical colleges with approximately 350 COVID-19 patients. The phase 3 trials will take 3-4 months, and if everything goes according to plan, it will hit the market (subject to regulator approval) by March 2021.
The drug was originally developed, over the course of 12 years, for small cell lung cancer (under trial) and showed a positive response against COVID-19.
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A statement released by PNB Vesper said that PNB-001 was found extremely safe in phase 1 trials, with expected pharmacokinetics and pharmacodynamics, leading to phase 2B and 3 trials. It was tested on 74 healthy individuals at low, moderate, and high doses over a course of various periods. The pre-clinical models, PNB-001 was found to be 20 times more potent than Aspirin and was highly effective at reducing inflammation. The drug might also have prophylactic properties – if taken at a specific dosage, it might prevent a COVID-19 infection.
P N Balaram, the CEO of PNB Vesper said, “This is indeed a very big step for mankind in its fight against COVID-19. Considering the novel mechanisms of our molecule, we expect much better results in the trials compared to Dexamethasone. We have proved in the pre-clinical studies that our drug is effective in reducing fever, body pain and inflammation. 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.”
PNB Vesper has thus entered a race with global pharma giants like Merek, who are also developing drugs for SARS-CoV-2.