FDA, Acer Agree on Edsivo Pivotal Clinical Trial

Acer Therapeutics says it is planning a pivotal clinical trial of its Edsivo (celiprolol) in patients with COL3A1+ vascular Ehlers-Danlos syndrome (vEDS). The company says the agency agreed with its submission of a proposed protocol under a special protocol assessment with a possible breakthrough designation.

Minutes from a recent Type B meeting with the agency indicate that FDA accepted the proposal for a decentralized (virtual) clinical trial design and use of an independent centralized adjudication committee; acceptability of a primary endpoint based on clinical events associated with disease outcome; agreement with modest safety data collection and no pharmacokinetic data needed to be collected; and a statistical plan that considers the rare disease classification of vEDS.

Acer says it will submit an IND and a protocol for the planned study in the second half of the year. It will request a breakthrough therapy designation at the same time, it says.