Cereno Scientific

Randomization of the first patient in EPIMODE has taken longer than initially anticipated following a prolonged trial start-up phase. An unforeseen patient-related event also contributed to the delay: a patient scheduled for randomization experienced a fall and was hospitalized the day before the scheduled visit. The event occurred before any study treatment had been administered.

In parallel, activation of additional sites continues to expand the EPIMODE trial’s recruitment capacity. Based on the current site activation and recruitment plan, Cereno Scientific continues to target completion of recruitment during 2027 and topline results in Q4 2028.

While the first patient randomization, also referred to as First Patient In (FPI), is an important operational milestone for EPIMODE, the timing of the trial’s topline results is driven by recruitment performance across all participating sites and when the last patient is randomized.

“The expansion of the number of sites activated in the EPIMODE trial marks an important period of execution for our lead CS1 program. With up to 15 sites expected to be activated by the end of 2026, and more site activations planned globally thereafter, our focus is on translating site activation into patient identification, screening, and randomization. EPIMODE is designed to build on the encouraging signals observed with CS1 to date and further define CS1’s clinical potential in a global, randomized, placebo-controlled Phase IIb trial. Based on the current plan, we continue to target completion of recruitment during 2027 and anticipate topline results in Q4 2028,” said Sten R. Sörensen, CEO of Cereno Scientific.

Key milestones of the global EPIMODE trial

• Up to 15 clinical sites are expected to be activated by year-end 2026.
• More than 50% of the planned global clinical sites are expected to be activated by the end of Q1 2027.
• Patient recruitment is planned to be completed during 2027.
• Topline results continue to be anticipated in Q4 2028.

Why the expanding site network matters

As additional specialist PAH centers become operational, the global site network available to identify, screen and randomize eligible patients will increasingly broaden. This planned expansion supports Cereno Scientific’s objective of completing patient recruitment during 2027 and reporting topline results in Q4 2028.

EPIMODE is a global, randomized and placebo-controlled Phase IIb trial designed to evaluate efficacy, safety and tolerability, determine the optimal dose for further development, and provide additional insight into CS1’s potential disease-modifying effects. Progress in building the global recruitment network is therefore directly relevant to advancing CS1 toward its next major clinical data readout.

Global site activations progressing across three regions

Regulatory and site-level preparations are progressing across North America, Europe and South America. In Europe, site activations are anticipated to begin in Q4 2026, subject to regulatory approval. In South America, where clinical trial authorization is conducted through national regulatory processes, the first country is expected to begin site activation in Q4 2026, subject to regulatory approval. These activities are progressing alongside ongoing trial execution in North America.

Cereno Scientific is conducting the EPIMODE trial together with an experienced global contract research organization (CRO), investigators and specialist PAH centers.

EPIMODE is led by Professor Marc Humbert, Principal Investigator and Chair of the Clinical Steering Committee, together with Professor Sandeep Sahay, University of Houston, as Committee Co-Chair.

“Our focus is on ensuring that each participating center is positioned to effectively identify, screen and randomize eligible patients once activated. As the number of operational specialist PAH centers increases, so does the network available to support recruitment performance in the EPIMODE trial,” said Rahul Agrawal, CMO and Head of R&D at Cereno Scientific.

What EPIMODE is designed to evaluate

EPIMODE is a global, randomized, double-blind, placebo-controlled and dose-finding Phase IIb trial evaluating CS1 as an add-on to stable standard of care treatment in patients with PAH. The trial is designed to evaluate efficacy, safety and tolerability, determine the optimal dose for further development, and provide additional insight into CS1’s potential disease-modifying effects.

The primary endpoint is change in pulmonary vascular resistance (PVR) after the first treatment period of nine months. PVR measures the resistance to blood flow through the pulmonary circulation and the strain placed on the right side of the heart.

The study uses a two-stage design. During the first treatment period, participants are assigned to one of two CS1 dose levels or placebo. Participants are subsequently re-randomized in the second treatment period: those initially receiving CS1 may continue treatment or switch to placebo, while those initially receiving placebo transition to either of the two active CS1 doses. This means that all participants receive active treatment during part of the study. The design enables Cereno Scientific to assess how treatment effects develop, persist or change following continued CS1 treatment or a switch between CS1 and placebo, providing additional insights into the durability of treatment effects and CS1’s potential to modify the underlying disease processes in PAH.

In addition to PVR, the study will evaluate right-heart function, functional capacity, risk evaluation, biomarker changes, clinical worsening, patient-reported outcomes and pharmacokinetics. The total study period is 56 weeks.