India-based life sciences company PNB Vesper has reportedly completed the Phase II clinical trials of its proprietary drug, PNB-001 (GPP-Baladol), on Covid-19 patients.
In all the initial preclinical studies, the drug has demonstrated positive results, IANS reported.
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In addition, it lowered the death rate by 80%, whereas Dexamethasone, a popular drug for Covid-19, only provided a 20% death rate reduction.
Last September, the company received the Drug Controller General of India (DCGI) approval to carry out the Phase II trial on patients with moderate Covid-19 and on oxygen support.
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 was to analyse the safety of GPP-Baladol in patients with moderate Covid-19 infection 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.
The news agency quoted PNB Vesper Life Sciences CEO PN Balaram as saying: “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.”
