Candidate: Pacritinib
Type: Oral kinase inhibitor with specificity for JAK2, IRAK1 and CSF1R
2021 Status: PRE-VENT Trial Reclassified; Misses Primary Endpoint CTI announced topline results October 1 from the PRE-VENT trial (NCT04404361) showing that pacritinib missed the study’s primary endpoint of statistically significant improvement in the primary endpoint of progression to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or death by Day 28. The proportion showing imnprovement was 26.3% of pacritinib patients vs. 24.8% of placebo patients.
PRE-VENT was launched last year as a Phase III trial—but was re-classified September 23 as a Phase II study “due to shifting COVID-19 treatment landscape,” according to the company. As of September 28, the study was terminated through a decision to close enrolment early, the company disclosed on ClinicalTrials.gov.
PRE-VENT was designed to compare pacritinib/standard of care versus placebo/standard of care in hospitalized patients with severe COVID-19, including patients with and without cancer. The final PRE-VENT analysis was conducted following the randomization of 200 patients.
2020 Status: CTI on April 27 said it launched the Phase III PRE-VENT trial, designed to evaluate pacritinib in hospitalized patients with severe COVID-19. The randomized, double-blind, placebo-controlled multicenter study, will compare pacritinib plus standard of care vs. placebo plus standard of care in 358 hospitalized patients with severe COVID-19, including patients with and without cancer. The primary endpoint is the proportion of patients who progress to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or die by Day 28. An interim analysis will be conducted for futility after 154 patients have been enrolled.
CTI said it expects to commence enrollment of PRE-VENT in May at sites in the United States and in Europe with data expected by the end of 2020. The trial’s chief investigator is John Mascarenhas, MD, Associate Professor, Medicine, Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types:
● ANTIVIRAL
● VAX
● ANTIBODY
● RNA
