Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced that the first healthy volunteer has been dosed in the Phase I pharmacokinetic (PK) bridging study of the company’s novel HDAC inhibitor CS014. The FDA-aligned study is designed to support the continued clinical development of CS014 and a streamlined pathway toward a Phase IIb trial in pulmonary hypertension associated with interstitial lung disease (PH-ILD) starting in Q1 2027.
The “PK bridging” study is a clinical Phase I, open-label, randomized, two-period crossover pharmacokinetic (PK) trial in 14 healthy adult volunteers. The study is conducted in Sweden. The study will evaluate steady-state pharmacokinetics following seven days of repeat oral dosing of CS014 compared to valproic acid (VPA), a well-established HDAC inhibitor. The primary objective is to characterize total and unbound plasma concentrations of CS014 at steady state compared to VPA.
“The study is intended to provide important comparative pharmacokinetic data and aim to significantly shorten the clinical development timeline and reduce development costs for CS014,” said Rahul Agrawal, CMO and Head of R&D at Cereno Scientific.
CS014 is a proprietary deuterated HDAC inhibitor and a new chemical entity designed to optimize pharmacokinetic properties and metabolic stability while targeting disease-driving mechanisms relevant in rare cardiopulmonary diseases such as vascular remodeling, fibrosis, inflammation and thrombosis.
The PK-bridging study is designed based on feedback received in a pre-IND meeting with FDA and is expected to remove the need for additional non-clinical safety studies and a Phase IIa trial. This supports a streamlined and capital-efficient development pathway toward a planned Phase IIb trial in pulmonary hypertension associated with interstitial lung disease (PH-ILD) starting in Q1 2027.
“This marks an important operational and regulatory milestone for CS014 as we continue advancing the program toward Phase IIb development,” said Sten R. Sörensen, CEO of Cereno Scientific. “Dosing of the first volunteer demonstrates the strong execution capabilities of our team and partners and reflects our focused strategy to efficiently advance innovative therapies with disease-modifying potential for patients with rare cardiopulmonary diseases with high unmet medical needs.”
Results from the Phase I pharmacokinetic study are expected in mid-2026.
To help investors better understand the Phase I pharmacokinetic trial of CS014, we published an explanatory article on our website in connection to the approval: read here.
* Formal clinical trial name: A phase 1, open label, randomised, 2-period, 2 sequence, 7-days repeat-dosing, crossover oral pharmacokinetic trial comparing multiple dosing of CS014 to valproic acid in healthy adults.