PREVEnt Trial: Prevention of Rupture with Enzastaurin in Vascular Ehlers-Danlos Syndrome
With a heavy heart, we report that Aytu Biopharma, following a corporate review, has announced it is indefinitely suspending clinical development and removing expenses related to AR101/enzastaurin clinical trial for vEDS.
Aytu BioPharma, Inc. was sponsoring a clinical trial to evaluate the effectiveness of AR101 (enzastaurin) in preventing cardiac or arterial events in patients with:
- Vascular Ehlers-Danlos syndrome (vEDS)
- Confirmed COL3A1 gene mutation
The trial intended to study the investigational oral compound, enzastaurin, for its inhibition of the protein kinase C (PKC) pathway. The PKC pathway has been implicated in the pathogenesis of vEDS in mouse models. Enzastaurin has been previously studied in over 40 human trials including a range of cancers. The objective of the trial was to evaluate the effectiveness of AR101 (enzastaurin) in preventing cardiac or arterial events in patients with vascular Ehlers-Danlos syndrome (VEDS) confirmed with COL3A1 gene mutations, compared to placebo.