The specialty pharmaceutical company, Aytu BioPharma, Inc. (Nasdaq: AYTU), announced this week that it has received U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for AR101/enzastaurin for vascular Ehlers-Danlos syndrome (vEDS).
This clearance will enable the company to commence its pivotal PREVEnt clinical trial in early 2022, investigating the ability of enzastaurin to reduce the severe complications of vEDS. There are currently no FDA-approved therapies for vEDS.
What is the PREVEnt trial?
The PREVEnt Trial will see Aytu BioPharma, Inc. (Nasdaq: AYTU) enroll approximately 260 COL3A1-positive vEDS patients. The study will randomize patients 1:1, with half receiving enzastaurin 500 mg once daily along with the standard of care and half receiving a placebo once daily along with the standard of care. The study’s primary endpoint is a reduction in fatal and non-fatal arterial events (ruptures, dissections, pseudo-aneurysms).
How can people living with vEDS get involved?
The Ehlers-Danlos Society is delighted to be supporting this study, which gives much-needed hope for those living with vEDS and their families, as part of the key stakeholder group. The Ehlers-Danlos Society will help to facilitate collaboration through the vEDS working group of The International Consortium on Ehlers-Danlos Syndromes and Hypermobility Spectrum Disorders, and with the enrolment of study participants through our global registry.
We will update our community with updates on the trial and how to get involved through the global registry when enrollment begins. Join our CONNECT newsletter to stay up to date.