Ovid Therapeutics is pumping the brakes on a planned phase 2 trial for its ROCK2 inhibitor in a type of brain lesion while it considers any lessons to be learned from the mixed readout of Recursion’s rival candidate.
Ovid and its partner Graviton Bioscience were preparing for the study of their OV888/GV101 capsule in patients with cerebral cavernous malformations (CCM), an irregular blood vessel that can form in the brain or spinal cord. The companies had already secured the go-ahead in Israel and were in the process of securing regulatory clearance in other regions.
Instead, they will now “take a strategic pause to evaluate clinical design learnings emerging from competitor phase 2 programs,” Ovid said in its third-quarter earnings release.
“The companies are confident in the potential therapeutic effects of ROCK2 inhibition for CCM and will seek to optimize future development approaches with the benefit of further insights on study duration, enrichment strategies, endpoints, and time-to-event measurements,” the biotech added.
Meanwhile, Ovid and Graviton will “continue to pursue additional formulations of OV888/ GV101 for undisclosed cerebral vascular conditions with high unmet need.”
While Ovid’s release didn’t single out the competitor programs it would be keeping an eye on, William Blair analysts said in an accompanying note that the biotech would be assessing the lessons from a recent phase 2 trial of Recursion’s REC-994 in CCM.
While Recursion’s superoxide scavenger scored a hit on the primary endpoint of safety and tolerability, the efficacy data were only able to show “a trend towards reduced lesion volume and hemosiderin ring size” at the higher dose compared to placebo. Hemosiderin is a protein that surrounds more advanced, bleeding cavernous malformations and is seen on MRI.
To top it off, Recursion saw no improvements on patient-reported outcomes or physician-led measures after 12 months of treatment.
As well as Recursion’s mixed results, New York-based Ovid is likely to be keeping an eye on a proof-of-concept study sponsored by the University of Chicago testing the common cardiovascular med atorvastatin in CCM patients.
“The study is expected to be completed in the first quarter of next year according to clinicaltrials.gov and could provide useful insight for Ovid’s planned trial,” the analysts added.
With OV888/GV101’s phase 2 trial on pause for now, the brain-focused biotech’s only program already in the clinic is OV329, a GABA aminotransferase inhibitor being developed for conditions with neuronal hyperexcitability.
"With a clear and disciplined capital strategy, we're channelling our resources toward programs that we believe have the greatest potential to deliver meaningful clinical outcomes and pivotal milestones within our financial runway,” Ovid CEO Jeremy Levin said in the Nov. 12 release.
“This includes the proactive decision to pause the initiation of the phase 2 program in CCM to incorporate fresh insights from recent competitor trials in an effort to strengthen the approach for this community.”
William Blair analysts said Ovid’s plans to add more dose cohorts to the phase 1 study of OV329 as well as press pause on the OV888 phase 2 study were “prudent approaches to maximize clinical potential and preserve resources, while acknowledging the potential delay to clinical data.”