Cereno Scientific today announced that the timelines for the upcoming clinical Phase II with drug candidate CS1 has been set following the signing of the final agreements with clinical research organization Worldwide Clinical Trials. The preparatory work together with Worldwide has proceeded since a letter of intent (LOI) was signed earlier this year, resulting in a study timeline for the Phase II study with CS1 in PAH anchored with relevant parties. If the study timeline is followed according to plan, the first patient will start in September 2021 with study results expected in H2 2022.
After the intense work with CS1, first in successful preclinical and Phase I studies and now preparing for a Phase II study, we are excited to have the study start in sight. We do, however, first have a set of milestones ahead such as obtaining permission to start the study (IND acceptance) that we are looking forward to check-off,” says Sten R. Sörensen, CEO of Cereno Scientific. “Looking at the overarching confirmed timeline though, we are nearly aligned with the original estimation of the study results announcement, which ultimately is one of the key milestones for us.”
Additionally, the study design has been confirmed for the clinical Phase II study to demonstrate drug candidate CS1’s safety, tolerability and exploratory efficacy in patients with the rare disease pulmonary arterial hypertension (PAH). The primary endpoint is safety and tolerability. In addition, all standard efficacy endpoints for this patient group will be explored as well as a calculated validated risk score. The dose to be used in later studies will be derived from cutting-edge technique with continuous monitoring of pulmonary pressure. The study will be conducted under the orphan drug designation (ODD) status awarded by the US FDA and be run at at least 6 different clinical sites in the US. It will include 30 patients. Dr. Raymond Benza, a global thought-leader in PAH and part of Cereno’s scientific advisory board, will be the principal investigator (PI) of the study.