Aytu BioPharma, a pharmaceutical company focused on developing and commercializing novel therapeutics, has announced the initiation of the global Phase 3 PREVEnt (Prevention of Ruptures with Enzastaurin for Vascular Ehlers-Danlos Syndrome) clinical trial of enzastaurin (AR101) for the treatment of patients with COL3A1-positive Vascular Ehlers-Danlos Syndrome (VEDS). The company has begun patient identification and study site contracting and has received regulatory clearance to initiate this registrational study in the United States and numerous countries in Europe.
“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,” said Josh Disbrow, Chief Executive Officer of Aytu BioPharma. “The PREVEnt Trial is global in nature with an anticipated 30+ sites across the US and Europe. We have received an FDA Safe to Proceed Letter, and in Europe have garnered Regulatory Authority and Ethics Commission approvals to begin clinical work in multiple countries. We anticipate additional country-specific approvals in the coming months.”
Topher Brooke, Executive Vice President of Rare Disease Development of Aytu BioPharma, commented, “We are so grateful to all the clinical trial sites for their efforts in aiding our study start up with the aim of dosing a first patient by early 2023. In coordination with trial sites and patient advocacy organizations in the US and Europe, we plan to make it as easy as possible to participate in the PREVEnt Trial, including allowing patients to continue any VEDS-related therapies they are currently taking for the duration of the study.”
The PREVEnt Trial is a prospective, Phase 3, global, randomized, double-blind, placebo-controlled efficacy trial designed to evaluate enzastaurin in patients with genetically confirmed COL3A1-positive VEDS. The primary measure of the trial is to determine whether enzastaurin reduces the occurrence of VEDS-related arterial events (ruptures, dissections, pseudoaneurysms, carotid-cavernous fistula, aneurysm) requiring medical intervention compared to placebo. The company expects to enroll approximately 260 COL3A1-confirmed VEDS patients in the PREVEnt Trial. Individuals seeking more information on the enzastaurin pivotal clinical trial are invited to visit www.preventvedstrial.com and https://clinicaltrials.gov/ct2/show/NCT05463679?term=Aytu+BioPharma&draw=2&rank=1
Those in the US who are interested in trial participation should visit preventvedstrial.com.
Throughout the newly updated website, you will see an orange button that reads, “SEE IF YOU QUALIFY.” If you are interested in potentially participating in the PREVEnt Trial, you may click this button to complete a short questionnaire. The questionnaire should only take a minute or two and will help study investigators to determine whether or not you may be eligible to participate. You will also be given the opportunity to select from a variety of potential study site locations. Once the study begins screening potential participants, you will be contacted by the site you have selected to learn more and to determine if you may be eligible to participate. The eligibility survey for trial sites in Europe is not yet open at this time but will follow.
Read the full press release here.