The Kochi-based Pharma Research company PNB Vesper life science Pvt has reportedly completed the phase IIb clinical trials of its proprietary drug, PNB-001 (GPP-Baladol), on COVID-19 patients.
In the phase 2 trial, the effect of PNB 001 was compared with dexamethasone, which is a corticosteroid used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects and had shown efficacy in reducing the symptoms of COVID-19 patients.
Based on recent studies, PNB-001 was found to lower the death rate by 80%, whereas dexamethasone, only provided a 20% reduction, announced the company.
PNB001 is an anti-inflammatory analgesic drug molecule that has the potential to reduce the cytokine storm by a dual mechanism of action compared to corticosteroids.
“PNB-001 has an action on the inflammatory cytokines by the cholinergic anti-inflammatory pathway and the gastrin- releasing peptide (GRP) receptor pathway. It has a potential to reduce the pro-inflammatory cytokines, and in turn, the cytokine storm which is the main cause of fatalities in COVID-19 patients.” told P N Balaram, CEO of PNB Vesper Life to Future Medicine.
“It is a CCK antagonist which is not an immunosuppressant like other available treatments and this is the exclusivity of this molecule by dual-action through two pathways,” he added.
The company had received approval from the Drug Controller General of India (DCGI) to carry out the phase II trial on patients with moderate COVID-19 and on oxygen support in September 2020.
The trial was designed in-line with the solidarity trial of the World Health Organization (WHO) and other international trials and had 40 patients. Its primary objective was to assess the overall efficacy of the drug in terms of outcomes like changes from the baseline in the ordinal scale and mortality by day 28.
The secondary objective is to analyse the safety of PNB-001 in patients with moderate COVID-19 in terms of various outcomes. They include improvement in inflammatory segments in X-ray, stay time in the hospital, assisted ventilation time, improvement in oxygen saturation. Additional outcomes include the number of days taken for a negative PCR result and change in inflammatory markers from baseline.
For evaluating the effectiveness of the drug, patients were divided into two groups and given the standard of care described in the Clinical Management Protocol of the Ministry of Health and Family Welfare, in line with WHO protocols. One of the groups of subjects received 100mg GPP-Baladol thrice a day at a dose along with the standard care.
“Considering the novel mechanism of action of the drug and the clinical trial outcome, PNB-001 (GPP-Baladol) can be a possible option to save the hospitalised patients…So far, most of the patients treated with PNB-001 showed significant clinical improvement even in the early days of their treatment,” Balaram said in a statement.