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A Kerala BioPharma company gets DCGI nod for Phase-2 clinical trial for novel drug to treat COVID-19

Bangalore, 14 September 2020: The phase 2 clinical trials of the molecule PNB-001 will soon start at BMJ Medical College, Pune and will be completed in 60 days, PNB Vesper managing director, Mr PN Balaram told media in Kochi on September 14, 2020.

BIRAC (Biotechnology Industry Research Assistance Council) of the Department of Biotechnology (DBT), Government of India, had sanctioned Rs 3 crore soft loan to support the development of the molecule for pain management. The molecule has got a US patent in December 2014. BIRAC has also given a grant of Rs 2.74 crore to development products for unmet medical needs.

According to Mr Balaram, the company is exploring clinical trials of the drug in the UK and USA. In India, about 40 patients with mild symptoms of COVID-19 who require o.xygen support will be enrolled for the Phase 2 trials.

PNB Vesper says it is a breakthrough treatment in the world. The company says COVID-19 presents with symptoms of pyrexia, pain and lung inflammation .PNB-001 has potential to decrease the fever, pain and pro-inflammatory cytokines as proved in pre-clinical studies and has been observed that PNB001 decreased the mortality rate by about 80% compared to control group in animal studies. PNB-001 has the potential to prevent the cytokine storm by binding to CCK-BR receptor in lung. This will reduce the fatalities in COVID 19 Patients.

This little known company, incorporated in Kochi in May 2011, has two directors, Mr PN Balaram and Mr K Sadasivan Pillai. Mr Balaram holds 51% of the shares. The other major shareholder is PNB’s associate company, Cybele Herbal Laboratories that has 40% of the shares. Mr Balaram has a background in the electronics industry and was key manufacturer of Toshiba televisions in India.

So what motivated Balaram to venture into the research-driven pharma industry, especially with no background in this domain? Mr Balaram told Express Pharma magazine in 2019, “I cannot give a definite answer for this question. Circumstances led me to conduct drug research. Maybe the almighty assigned this task to me. One thing is for sure, if we are successful in our research, the society will be majorly benefited.”

PNB Vesper has a “semi-virtual” operational methodology with key research, pre-clinical and development activities being carried out by key management personnel in the UK , USA and Thailand besides India. The company says the products that it is working on has been under development by these academics for over 14 years in their laboratories.

Two key management personnel are Dr Eric Lattmann, Vice President (research) and Dr Pornthip Lattmann, VP( regulatory affairs), both based in the UK. The chief scientific officer, Dr Ramesh Narayan is a US citizen. Dr Pornthip had founded a clinical trials company, APL Molecules in the UK that has since been dissolved. She founded another company, Simply Molecules that has been merged into PNB Vesper.

The company has an international Scientific Advisory Board comprising Prof MJ Tisdale, a specialist in COX-2 inhibitors used in cancer treatment, Dr L Standker, a peptide therapeutics expert in Germany, Dr Gary McCleane, a consultant in pain management and Dr Jintana Sattayasi, a professor of pharmacology at Khor Kaen University, Thailand.

The company continues to invest heavily into research and development with government grants, bank loans and personal investment from the promoters. In 2018, its annual revenue was just over one lakh rupees, mainly interest from bank deposits.

PNB Vesper is actually ivolved in developing drugs for unmet medical needs. PNB Vesper has synthezised hundreds of molecules and systematically characterized to select lead molecules. The lead molecules have the potential to treat variety of diseases including pain, cancer, inflammation such as inflammatory bowel disease (IBD), neurological diseases such as anxiety, depression, metabolic diseases, and others. PNB Vesper’s assets are well protected by intellectual property filings both in US and many other countries in the around the World, which will not expire until 2036.

The 9-year, startup, PNB Vesper Lifesciences claims its PNB-001, a molecule that can reduce pro-inflammatory cytokines (IL-6), is the world’s first novel chemical entity to treat COVID-19. The molecule development has been funded by BIRAC under government of India.

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