Lili Nsongo's questions to Arcturus Therapeutics Holdings (ARCT) leadership • Q2 2025
Question
Lili Nsongo of Leerink Partners inquired about the clinical success criteria for the ARCT-032 cystic fibrosis program and the patient mix of modulator-eligible versus non-eligible participants in the ongoing Phase 2 trial.
Answer
President and CEO Joseph Payne explained that while a 3% FEV1 improvement is a historical benchmark from modulator trials, the FDA's primary requirement for ARCT-032 is to establish safety, tolerability, and any positive measurable FEV1, given the novel inhaled approach and the high unmet need in the Class 1 patient population. He confirmed that a "strong majority" of the first nine participants are Class 1 or modulator non-responders.