Posted by Michael Wonder on 19 Apr 2022
Aytu BioPharma announces fast track designation granted to AR101 for the treatment of vascular Ehlers-Danlos syndrome
19 April 2022 - Aytu BioPharma today announced that the U.S. FDA has granted fast track designation to AR101 (enzastaurin), a protein kinase C (PKC) β inhibitor, for the treatment of patients with vascular Ehlers-Danlos syndrome.
The PREVEnt Trial is designed to enrol approximately 260 COL3A1 positive vascular Ehlers-Danlos syndrome patients in order to assess time to arterial events leading to intervention among patients treated with AR101 compared to patients treated with standard of care. Including the planned enrolment period, the study is expected to last approximately thirty months.
