PNB Vesper, a leading Kerala based Life Sciences Company, today announced that it has successfully completed the phase 2 clinical trials of its proprietary drug PNB-001 (GPP-Baladol) on COVID-19 patients.
PNB Vesper, a Kerala based Life Science Company has successfully completed a phase-2 clinical trial of its proprietary drug GPP-Baladol in Covid-19 patients.
The trial was conducted in 40 patients and the primary objective of the clinical trial was to evaluate the overall efficacy of the drug in terms of outcomes such as a change from the baseline in the ordinal scale and mortality by day 28.
The secondary objective was to evaluate the safety of GPP-Baladol in patients with moderate COVID-19 infection in terms of outcomes such as improvement in inflammatory segments in X-ray, duration of hospital stay, duration of assisted ventilation, improvement in oxygen saturation, number of days for a negative PCR result and change in inflammatory markers from baseline.
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“Our medicine will help in controlling other complications among heart patients and highly diabetic patients. The administration of GPP-Baladol will reduce the Lymphocytes and Neutrophils ratio (L&N) ratio considerably and increase the immunity in the body. We have already begun the discussions. Globally we are planning to tie up with 3 pharmacy companies. On February 22nd, we will submit the complete data to the central Health Ministry, following which we will reveal the complete data to the public. We can assure the public that this will be the safest and one of the most efficient medicines as far as Covid-19 is concerned,” said PN Balaram, CEO PNB Vesper Life Science Private Limited.
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 the patients treated with GPP-Baladol reported any post-treatment health risks. There are about 28 post-covid long-term complications identified by the World Health Organization and our treated group does not pose any such long-term health risks all participants are feeling healthy compared to the standard arm, Mr Balaram added.
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. In order to assess this effectiveness, the patients were divided into two groups and both groups were provided with the standard of care described in the Clinical Management Protocol of the Ministry of Health & Family Welfare (MoHFW), in-line with the WHO protocol. The other group, in addition to the standard of care, was given GPP-Baladol thrice a day at a dose of 100 milligrams.