Cereno Scientific receives approval to initiate FDA-aligned Phase I pharmacokinetic study of CS014 supporting Phase II development in pulmonary hypertension associated with interstitial lung diseases (PH-ILD)

Swedish biotech Cereno Scientific has received approval from the Swedish Medical Products Agency to begin a Phase I study of its experimental drug CS014, a new HDAC inhibitor being developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD). The study, designed in line with FDA guidance, will compare CS014’s pharmacokinetics to valproic acid (VPA), a well-established drug in the same class, in 14 healthy volunteers. A successful outcome is expected to eliminate the need for additional safety studies and a Phase IIa trial, allowing the company to proceed directly to a Phase IIb trial planned for Q1 2027. Results are expected in mid-2026.

Read more on the company press release at this link

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