PK - Acer Therapeutics plans clinical trial of Edsivo in connective-tissue disorder

Following a recent Type B meeting with the FDA, Acer Therapeutics (ACER), plans to conduct clinical trial of Edsivo (celiprolol) in patients with COL3A1+ vascular Ehlers-Danlos Syndrome (vEDS).EDS is an inherited disorder that affects the connective tissues in the body - primarily skin, joints and blood vessel walls.The company has sought FDA's opinion on various proposed design features of the study. The official meeting minutes confirm details of the discussion, including: the acceptability of a decentralized (virtual) clinical trial design; acceptability of a primary endpoint; agreement with modest safety data collection and no pharmacokinetic data needing to be collected. In H2, Acer intends to submit a protocol for the prospective study, along with an IND application, request breakthrough therapy designation, and coordinate with FDA to reach agreement on a Special Protocol Assessment.Based on initial power calculations, Acer anticipates that the trial should enroll approx. 200 COL3A1+ vEDS patients in the U.S., and the duration of

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Acer Therapeutics plans clinical trial of Edsivo in connective?-tissue disorder