Aytu Initiates vEDS Clinical Trial
In July, I had the opportunity to join vEDS patients at the Marfan Foundation Conference in Newport Beach, California. It was clear from interacting with vEDS patients that the community is excited. Part of this energy came from being in person with one another - something many of us hadn't had the chance to do since the start of the pandemic. But much of the group's enthusiasm stemmed from the upcoming clinical trials and the potential to find a treatment, which were highlighted during the conference.
Recent news from Aytu Biopharma should give us even more optimism. Over the past several months, Aytu has announced major steps toward the clinical trial for a treatment for vEDS (read the details behind the treatment on our Clinical Trials Page).
You can also pre-enroll to make sure you have the opportunity to participate when the trial launches.
In July, Aytu published a press release announcing the initiation of the clinical trial. This announcement shared a few important points:
Aytu has received regulatory clearance to initiate the study in the United States and numerous countries in Europe
The company has begun site contracting (that is, working with facilities to prepare them to enroll patients)
Aytu is beginning the patient identification process
As a part of initiating the trial, they've posted details about the study on clinicaltrials.gov, which can help us to better understand what Aytu is planning. Some of the highlights include:
Start Date: Study start is anticipated for January 2023 (they've separately said the first patient would be dosed in early 2023)
Number of patients: 260 patients
Age Inclusion Criteria: Subjects aged 18 - 60 years old at time of initial screening
Genetic Confirmation Requirement: Diagnosis for VEDS (vascular Ehlers Danlos Syndrome), with a confirmed and documented COL3A1 genetic variant
Vascular Event Criteria: No VEDS-related vascular events within the past 3 months prior to enrollment
What Patients Can Do
Over the past several months, we at FIGHT vEDS have been communicating with many of you about the best way to prepare for the trial.
With the initiation of the trial, Aytu has launched a form on their website to help patients see if they qualify and sign up for updates. We highly recommend that interested patients sign up now. This is not a commitment to enter the study, but does make sure you're on Aytu's list when they start contacting patients.
For those eager to participate without a genetic confirmation of their vEDS diagnosis - you can visit our genetic testing page. Genetic testing will likely be re-confirmed prior to enrollment but this will be important given the genetic confirmation requirement mentioned above.
And subscribe to our updates at the bottom of the FIGHT vEDS homepage - we will continue to share updates as the trial comes closer.