Cereno Scientific has announced significant progress in the recruitment of patients into the phase 2 study evaluating the efficacy and safety of its lead therapeutic candidate, CS1, in pulmonary arterial hypertension (PAH).

“It is great to finally see recruitment taking off after an unforeseen extended start-up and activation phase. With all centers active in the screening process, and with amended eligibility criteria to facilitate identification of patients for screening visits and enrollment, we are now starting to see the real effect of these activities,” said Björn Dahlöf, chief medical officer at Cereno Scientific, in a press release.

“Already, 1/3 of the patients have consented and entered the study with a successful first visit. We foresee that our target to enroll 30 patients who meet the criteria are being recruited into the study in the coming months.”


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From the 10 patients who have enrolled the study at the end of March, 3 have already been randomized. The remaining 7 are now on track for randomization.

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Cereno Scientific expects several more patients to enter the study in the upcoming weeks to comply with the timeline of presenting topline results at the end of 2023.

“The unmet medical need for patients with PAH is a treatment challenge. We believe our drug candidate CS1 has the potential to meet that challenge, to make a major difference in the future treatment landscape and I am happy that we now can announce real progress in patient recruitment in this innovative study,” said Sten R. Sörensen, CEO at Cereno Scientific.

About 2 weeks after the first visit of the study, participants will be implanted with the CardioMEMS HF System to remotely monitor changes in pulmonary artery pressure.

Then, after 4 to 6 weeks of CardioMEMS HF measurements, participants will undergo a full baseline evaluation and will be randomized to 1 of 3 doses of CS1. After 12 weeks of an active treatment period, all measurements will be repeated to be compared with baseline measurements and between doses.

The study also includes a follow-up visit 2 weeks after the CS1 treatment period. In total, the maximum duration of the study is 22 weeks.

The US Food and Drug Administration granted Orphan Drug Designation to CS1 for PAH in March 2020.

Reference

Cereno Scientific reports 1/3 of patients recruited into CS1 phase II study in rare disease pulmonary arterial hypertension (PAH). News release. Cereno Scientific; April 4, 2023.