Cereno Scientific’s HDAC inhibitor hit the primary endpoint of safety and tolerability in a Phase 2a trial in patients with pulmonary arterial hypertension, sending its Swedish-listed stock up {$CRNO.B} about 20% in trading on Monday.
Cereno CEO Sten Sörensen said Friday in a statement that the company’s drug, dubbed CS1, also showed a “positive impact already after 12 weeks on clinical parameters meaningful to patients and regulatory authorities.”
The company said that it will now work with regulatory authorities on moving forward with a pivotal trial.
In the trial, nine out of 21 patients, or 43%, had an improved REVEAL risk score and 15 out of 21 patients, or 71%, improved or had a stable risk score. The REVEAL score helps predict survival in patients with the disease.
Other parameters like mean pulmonary arterial pressure and functional class improvement also showed promise: 14 out of 21 patients (67%) showed a sustained pressure reduction, while seven out of 21 patients (33%) improved functional class and 18 out of 21 (86) improved or had a stable functional class.
Cereno shared data from an analysis of a subgroup of patients with a “remarkable response” to CS1. In the analysis, 25% of patients responded to the drug with “remarkably large reductions in pulmonary vascular resistance,” according to the company.
On Monday, Cereno announced that it’s teaming up with medical technology company Fluidda in order to use its imaging tech for CS1. The company said its technology assesses “structural and functional changes in the lungs and blood vessels,” and can help examine how drugs are working.
“This collaboration will allow Cereno to use Fluidda’s cutting-edge technology to visualize CS1’s ability for long-term reverse remodeling in PAH patients,” Sörensen said in the release.
Editor’s note: This story’s headline has been updated to clarify the trial’s endpoints.