CTI BioPharma has reported topline data where its oral drug, pacritinib, failed to meet statistical significance for the primary goal of the PRE-VENT clinical trial in severe Covid-19 patients admitted to hospital.
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Pacritinib is an experimental oral kinase inhibitor.
The double-blind, randomised, placebo-controlled multicentre trial analysed pacritinib plus standard of care against placebo plus standard of care in Covid-19 subjects and included those with and without cancer.
The proportion of subjects advancing to receive invasive mechanical ventilation and/or extracorporeal membrane oxygenation or succumbed by day 28 was the trial’s primary goal.
The trial was recently modified to a Phase II design due to the accessibility to Covid-19 vaccines and the evolving pandemic situation.
The final assessment was carried out after randomising 200 subjects in the trial.
According to the trial findings, 26.3% of subjects in the pacritinib arm progressed to receive invasive mechanical ventilation and/or extracorporeal membrane oxygenation or died by day 28 Versus 24.8% in the placebo arm.
Data suggest that the treatment did not offer a statistically significant improvement in the primary goal, CTI BioPharma noted.
Pacritinib was demonstrated to be well-tolerated in subjects with reduced rates of grade 3+ events.
Serious adverse events were observed in the pacritinib arm versus the placebo arm.
CTI BioPharma president and CEO Adam Craig said: “Last year, we launched the PRE-VENT study of pacritinib in patients with severe Covid-19 in response to the pandemic and an unprecedented medical need to improve outcomes for these patients.
“Although pacritinib was well tolerated on study, it did not demonstrate a clinical benefit in treating the sickest patients with Covid-19.”
Based on the latest trial data, the company decided not to progress the pacritinib development to treat patients with severe Covid-19.
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How is the Biopharmaceutical industry evolving?
- Benchmark the impact of major themes on the Biopharmaceutical industry.
- Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
- Evaluate the effects of COVID-19 on the sector.