The city-based PNB Vesper Life Sciences has successfully completed phase 2 clinical trials of PNB-001 (GPP-Baladol), its proprietary drug to treat the coronavirus infection and said it will soon move the government for deploying the drug for emergency use.
The company, which has its labs in England, had in early September 2020 received the approval from the Drug Controller General (DCGI) to conduct the phase 2 clinical trial of GPP-Baladol in patients with moderate infection of the pandemic with oxygen support.
The company on Monday said the clinical trial was initiated in November at BJ Government Medical College and Sassoon General Hospital in Pune, and Victoria Medical College and Research Institute in Bengaluru on 40 patients.
"We will submit the clinical trial report to the DCGI on Monday itself," the company's promoter and chief executive PN Balaram said, adding the trial protocol was designed in-line with the solidarity trial conducted by the WHO and other international clinical trials.
On September 11, PTI had reported that PNB Vesper had secured the drug controller's permission to launch the phase II clinical trial for a potential COVID-19 drug -- making the Kochi-based firm the first in the world to begin such trial for a new chemical entity.
"The safety of GPP-Baladol was assessed by the adverse effects shown by the patients and based on functional blood chemistry analysis for liver and kidney and other vital parameters.. under the standard care described in the clinical management protocol of the Union health ministry. The patients were given 100 gm each of GPP-Baladol thrice a day," the company said.
"This is indeed a very big step for the mankind in its fight against the pandemic. Considering the novel mechanism of action of the drug and the clinical trial outcome, GPP-Baladol can be a possible option to save the hospitalised patients all over the world.
"So far, most of the patients treated with GPP-Baladol showed significant clinical improvement even in the early days of their treatment. Also, none of our patients reported any post-treatment risks. There are about 28 post-Covid long-term complications identified by the WHO and our treated group did not report any such risks, Balaram said.
He further said they will approach the government for an emergency use authorisation of the drug to treat the hospitalised patients in a clinical trial mode. We are already in discussions with the US and British governments on the same front, he said adding the drug already been patented in the US, Europe.
The 15-year-old PNB Vesper, which is a semi-virtual research firm, has developed six new chemical entities and the latest one PNB001, will be tested for the pandemic patients. The molecule was initially developed for lung cancers, Balaram had told PTI then.
Balaram owns 100 per cent of the company, has six American, British and German scientists as research partners.
Balaram said the clinical trial was carried out by the Thane-based Biospheric Clinical Research as a randomised, open label study to evaluate the efficacy and safety of PNB 001 in patients with moderate infections.
The third phase would be carried out on 378 patients at the AIIMS New Delhi, AIIMS Lucknow and other leading hospitals in Mumbai, Bengaluru, Chennai and Pune, Balaram had said, adding the first phase were carried out on 74 patients.