Cereno Scientific: CS1 Phase IIb now underway - Edison

Cereno Scientific has launched the global Phase IIb study for CS1 (EPIMODE) in pulmonary arterial hypertension (PAH) with the activation of the first clinical site. We view this as a meaningful execution milestone, clearing the path to patient recruitment (to commence mid-September) towards top-line results in Q428. The 56-week study will recruit c 126 patients across c 68 sites, providing the required controlled setting in which to evaluate CS1’s dose response, efficacy and proposed disease-modifying profile. EPIMODE is differentiated by its two-stage, re-randomisation design, optimised to assess dose response, efficacy and the durability of treatment effects across a broad patient cohort. The primary endpoint will be change in pulmonary vascular resistance (PVR) at nine months, a well-established objective haemodynamic measure in PAH. With clinical timelines broadly in line with our estimates, we leave our valuation unchanged ahead of upcoming Q226 results.