Provention Bio announced preliminary top-line results from its Phase 1b PULSE study which evaluated PRV-300, an anti-TLR3 (toll-like receptor 3) monoclonal antibody, in patients with active, moderate-to-severe ulcerative colitis (UC).
PRV-300 met the primary safety and tolerability endpoint over the twelve-week study period and also demonstrated TLR3 target engagement and proof-of-mechanism. However, improvements in secondary and exploratory clinical, endoscopic, histologic and other UC-related efficacy endpoints were not observed over background medication, suggesting that elevated TLR3 gene signatures previously observed in UC patients, as well as in PULSE, are downstream or circumstantial effects that do not contribute significantly to causal pathology.
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"I would like to thank the PULSE study patients, coordinators and investigators, as well as Provention's expert clinical development team, for their time, efforts, and dedication in conducting such a definitive, cost-effective, and efficient clinical trial," said Ashleigh Palmer, CEO of Provention Bio. "The PULSE study, which enrolled 37 patients at three sites in just seven months, exemplifies how Provention can rapidly determine go/no-go decisions regarding the further development of therapeutic candidates with the potential to intercept immune-mediated diseases. PRV-300 did not demonstrate an upstream effect on clinically relevant parameters in UC, but its favorable safety and tolerability profile, and demonstration of proof-of-mechanism, may offer an opportunity to sub-license this asset for evaluation in other indications, including severe influenza and emerging viral diseases, where an anti-TLR3 antibody has been successful in preventing the release of toxic inflammatory mediators in animal models."