City-based pharma research firm PNB Vesper has secured the drug controller's permission to launch phase-II clinical trials for a potential COVID-19 drug — making it the first in the world to begin such trials for a new chemical entity, a top company official said on Friday. The 15-year-old company has developed six new chemical entities and the latest one — PNB001 — will be tested for treating coronavirus patients. The molecule was initially developed for lung cancer, the company's promoter and chief executive P N Balaram said.
The firm's labs are located in Britain. He said the company on Thursday received permission from the Central Licensing Authority under the Central Drugs Standard Organisation for the second phase of clinical trials. This makes PNB Vesper the only company in the world to launch clinical trials for an all-new molecule for COVID-19 treatment, he added.
Balaram, who owns 100 per cent of the company, has six American, British and German scientists as research partners, who will join his Kochi office from next month. PNB001 (GPP-Baladol) has patent till 2036 in the US, Europe and many Asian countries, including India. The trials will be conducted on 40 COVID-19 positive patients at the BMJ Medical College, Pune.
The trials will be carried out by Thane-based Biospheric Clinical Research as "a randomised, open label study to evaluate the efficacy and safety of PNB 001 in patients with moderate COVID infections", according to a letter from the Central Licensing Authority. Balaram said the phase-I clinical trials were carried out on 78 patients in Ahmedabad by Lambada Therapeutic Research in February.
Based on the outcome of the phase-I trials, he said the PNB001 is 20 times more efficient than aspirin and has not shown any toxic reaction on the patients. If the second phase is successful, the company will go for the third phase trials on 378 patients in AIIMS New Delhi, AIIMS Lucknow and other leading hospitals in Mumbai, Bengaluru, Chennai and Pune, Balaram said. He further said if the trials are successful, PNB001 will be a USD 100 billion molecule opportunity.
However, he declined to share the investment the firm has made to develop the molecule. Two of its six cancer-focused molecules have moved from the preclinical development to human trials now, he added.
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