The Food and Drug Administration (FDA)’s recent clearance for a Cereno Scientific Phase IIb trial on CS1 builds on the favourable safety, tolerability and encouraging disease-modifying signals observed in the Phase IIa study. CS1, an HDACi that acts through epigenetic modulation, has also been granted Orphan Drug Designation and Fast Track designation in the US. The Phase IIb trial is designed to determine the optimal dose for a Phase III study and to further evaluate CS1’s potential to reduce pulmonary vascular resistance, improve functional capacity and assess key clinical measures when added to today’s standard treatments.
Read the full press release at this link
See also our previous article on this topic here