CorFlow Therapeutics has announced milestones in advancing its clinical programme, reaching phase 1 of the MOCA II US Food and Drug Administration (FDA) pivotal trial.
Safety and performance goals were met with ST-segment elevation myocardial infarction (STEMI) patients who had the proprietary PCoFI diagnostic measurement of microvascular obstruction (MVO) made during a stenting procedure, when compared to the reference standard diagnosis by cardiac magnetic resonance imaging (MRI) in the subsequent days.
Phase 1 included 19 patients enrolled across five US and three European sites. MOCA II follows the first-in-human (FIH) MOCA I study and primarily aims to validate the threshold value of the proprietary PCoFI measurement for diagnosing MVO in the setting of primary angioplasty compared to cardiac MRI. This milestone achievement, which was confirmed by the study’s independent Data and Safety Monitoring Board (DSMB) triggered the possibility for phase 2 to begin in a larger wave of clinical trial sites in both the USA and Europe.
The first patients in the MOCA II phase II study were enrolled by Marco Valgimigli at Cardiocentro Ticino Institute in Lugano, Switzerland.
“I am excited to see the next generation of the CorFlow technology and advancement of the clinical program where the international pivotal study is now underway, for which the interventional cardiology community will eagerly await the results,” said Valgmigli. “Once the technology is readily available, it can help drive decision making in the cath lab to improve our management of STEMI patients. Fast, accurate diagnosis of MVO is the key step we need to build from.”
CorFlow also announced that its parallel flagship clinical trial is now approved and can start enrolling patients. The novel randomised REVITALISE trial is now set to begin enrolment across UK, with France, Netherlands, and Spain following in the coming weeks.
REVITALISE is intended to prospectively test the effectiveness of the proprietary CorFlow Continuous Flow Infusion system (CoFI system) to deliver therapeutic agents in treating MVO in patients undergoing primary angioplasty for acute myocardial infarction with STEMI.
The trial intends to enrol at least 250 patients with early results expected in 2027 and data read-outs expected through 2028. The adaptive platform approach was selected due to its ability to add subsequent arms to the trial, testing the effectiveness of additional drug candidates delivered through the CorFlow system. Additional countries and research centres are also under evaluation.
