vEDS Clinical Trial

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.

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