Aytu BioPharma (NASDAQ:AYTU) has initiated the global Phase 3 PREVEnt clinical trial of Enzastaurin (AR101) for the treatment of patients with COL3A1-positive Vascular Ehlers-Danlos Syndrome (VEDS).
The PREVEnt (Prevention of Ruptures with Enzastaurin for Vascular Ehlers-Danlos Syndrome) study is a Phase 3 clinical trial designed to evaluate efficacy of Enzastaurin in patients with genetically confirmed COL3A1-positive VEDS.
The Vascular Ehlers-Danlos Syndrome (VEDS) is a rare genetic disorder typically diagnosed in childhood and identified by arterial aneurysm, dissection and rupture, bowel rupture and rupture of the gravid uterus.
The company expects to enroll approximately 260 subjects in this trial and dosing of first patient by early 2023.
Josh Disbrow, Chief Executive Officer, said, “We are excited about the progression of this global clinical trial evaluating a novel pathway for the treatment of VEDS, a devastating rare disease with massive unmet need. The PREVEnt Trial is global in nature with an anticipated 30+ sites across the US and Europe. We anticipate additional country-specific approvals in the coming months.”
Aytu BioPharma has received regulatory clearance to initiate this registrational study in the United States and in Europe.
Price Action : Aytu BioPharma shares are trading around 2 percent higher at $0.62 on Wednesday at the time of publication.
