Cereno Scientific has broadened the clinical development focus of its HDAC inhibitor CS014 to include pulmonary hypertension associated with interstitial lung disease (PH-ILD), as the company prepares for a Phase 2 clinical programme.

The Sweden-based biotech said the decision is intended to support a more clinically relevant Phase 2 study design, strengthen the development potential of CS014 and address a patient population with very high unmet medical need. The move expands the scope of the programme while keeping idiopathic pulmonary fibrosis (IPF) as a core disease area for the asset.

CS014 was originally developed with IPF as the initial indication. IPF is the most common form of interstitial lung disease (ILD), a group of fibrotic lung disorders characterised by progressive scarring of lung tissue. A significant proportion of patients with ILD, including many with IPF, go on to develop pulmonary hypertension, a complication associated with poorer outcomes and increased mortality.

By broadening the development focus to PH-ILD, Cereno aims to evaluate CS014 in patients where both fibrotic lung disease and pulmonary vascular pathology play a central role. The company said this reflects real-world disease characteristics and could support a more relevant Phase 2 clinical programme.

Sten R Sörensen, ceo of Cereno Scientific, said: “Broadening the development focus for CS014 to PH-ILD is a natural and scientifically driven evolution. It enables us to target a severe condition with very limited treatment options and is expected to strengthen the clinical and strategic positioning of CS014 without changing its underlying scientific rationale or long-term development focus.”

He added that the company believes the approach could support a more efficient development pathway. “The underlying rationale for this strategic focus is that we believe it will enable us to get CS014 faster to market at lower cost and with a higher probability of success.”

PH-ILD is considered a rare and life-limiting condition. Patients who develop pulmonary hypertension in the context of fibrotic lung disease typically experience reduced exercise capacity, faster disease progression and significantly worse survival compared with patients who have ILD alone. Current treatment options are limited and are largely focused on symptom management rather than modification of the underlying disease processes.

According to Cereno, CS014 targets several pathophysiological mechanisms that are shared across fibrotic lung disease and pulmonary vascular disease, including vascular remodelling, fibrosis, thrombosis and inflammation.

Rahul Agrawal, cmo and head of R&D at Cereno Scientific, said: “CS014 targets key pathophysiological processes that are shared across fibrotic lung disease and pulmonary vascular disease, including vascular remodeling, fibrosis, thrombosis and inflammation.”

He added that the expanded focus could improve study design. “By broadening the development focus to PH-ILD, we can design a Phase 2 study that better reflects real-world disease biology and for patients with worse prognosis.”

CS014 is an orally administered HDAC inhibitor being developed for severe cardiopulmonary diseases. The compound has completed a Phase 1 study, and Cereno said preparations are ongoing for a Phase 2 trial, which is planned to be initiated in Q1 2027.