Selection of CRO marks key milestone in advancing CS1 as a potential disease-modifying treatment

Cereno Scientific has selected a global contract research organization (CRO) to support its planned Phase 2b clinical trial of CS1, the company’s lead candidate for pulmonary arterial hypertension (PAH).

The agreement marks a key step toward initiating the multi-center, placebo-controlled study, which is expected to begin in the first half of 2026, pending regulatory approval.

CS1 is an epigenetic modulator believed to work through HDAC inhibition — a mechanism that has shown potential to reverse vascular remodeling and improve right heart function in patients with PAH, a rare and life-threatening disease with limited treatment options.

The selected CRO brings experience in rare cardiovascular and pulmonary indications, along with an established network of investigators and trial sites globally. Cereno noted the CRO’s track record in PAH studies and capacity for supporting large-scale international trials as key factors in its decision.

“Partnering with a CRO that combines deep expertise in the disease area with access to a well-characterized patient population is essential,” said Rahul Agrawal, chief medical officer and head of R&D at Cereno.

“Their infrastructure and scientific capabilities align well with our goals for the CS1 program.”

The upcoming Phase 2b study is designed to build on encouraging efficacy signals observed in the earlier Phase 2a trial, including signs of reverse vascular remodeling. The trial will assess safety, efficacy, and pharmacodynamics in a broader patient population across multiple geographies. Earlier this year, Cereno received supportive feedback from the US Food and Drug Administration (FDA) via a Type C meeting, endorsing plans for the Phase 2b protocol.

“Our selection of a clinical partner follows a rigorous procurement process and brings us one step closer to initiating the next phase of development for CS1,” said Sten R. Sörensen, CEO of Cereno Scientific.

“With a strong collaborator in place, we are well-positioned to advance our efforts to bring novel, disease-modifying therapies to patients with PAH.”

CS1 has received Orphan Drug Designation in both the US and EU for the treatment of PAH.

Preparations for an Investigational New Drug (IND) submission are currently underway.