Kochi-based pharmaceutical company PNB Vesper Life Sciences announced on Thursday that it has completed the Phase 2 clinical trials of a new Covid-19 drug — PNB-001 (GPP-Baladol). PNB Vesper Life Sciences CEO PN Balaram called it “a very big step for mankind in its fight against the Covid-19 pandemic”.
The clinical trial of the proprietary drug was held at the BJ Government Medical College and Sassoon General Hospital, Pune and Victoria Medical College and Research Institute, Bengaluru in November 2020. Although reports find the drug to be promising, its effectiveness is yet to be approved. The second phase of the trial was held at BJ Medical College and was conducted among 40 Covid positive patients, who are moderate patients on oxygen support. The clinical trial report will now be submitted to the DCGI on February 22.
A main objective of the clinical trial was to evaluate the efficacy of the drug in terms of outcomes — such as changes from baseline in the ordinal scale and mortality. The trial also appraised the safety of GPP-Baladol in patients with moderate Covid-19 infection. The safety of the drug was assessed by the adverse effects, based on functional blood chemistry analysis for liver and kidney, and other vital parameters.
The clinical trial patients were divided into two groups. While one group was provided with the standard of care described in the Clinical Management Protocol of the Ministry of Health and Family Welfare, in line with WHO protocols, the other group, in addition to the standard care, was given GPP-Baladol thrice a day at a dose of 100 milligrams.
According to Balaram, most of the patients treated with GPP-Baladol showed significant clinical improvement even in the early days of treatment. “None of the patients treated with GPP-Baladol reported any post-treatment health risks. There are about 28 post-Covid long-term complications identified by the WHO and our treated group do not pose any such long term health risks and are feeling healthy compared to the standard patient.”
He added that the company is approaching the government for emergency use authorisation of the drug to treat hospitalised patients in India in a clinical trial mode. “After knowing the efficacy of the drug in Covid-19 treatment, we are hoping to get immediate approval from the government to make the drug readily available for use in the treatment of hospitalised patients,” he said.
Meanwhile, after immunisation of health workers in Kerala for nearly a month, the focus of the coronavirus inoculation drive shifted on Thursday to frontline workers from the revenue, police, fire and local self-government departments. After the second phase gets over in a few days, the second dose to healthcare workers will be administered from February 15. An estimated 3.75 lakh healthcare professionals have taken the first dose so far in the state.