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.
The suspension is expected to save the Company over $20 million in projected future study costs as it announced a shift of strategy aimed at accelerating the growth of its commercial business and achieving profitability.
Josh Disbrow, Chief Executive Officer of Aytu BioPharma, explained: “We understand that the suspension of our AR101 clinical development program is a disappointment to the vEDS community. We did not take this pause of our clinical development efforts lightly and intend to revisit the program at the appropriate time with the expectation of funding all future clinical development with internally generated cash flow or through partnering.”
Due to the suspension, recruitment for the PREVEnt trial to evaluate the effectiveness of AR101 (enzastaurin) in preventing cardiac or arterial events in patients with vascular Ehlers-Danlos syndrome or confirmed COL3A1 gene mutation will cease.
We understand how disappointing this is for advancing research for those living with vEDS. The Ehlers-Danlos Society remains committed to supporting research into vEDS to give much-needed hope to those living with vEDS and their families. The Ehlers-Danlos Society will continue to fund research through its research grant program, and help to facilitate collaboration through the vEDS working group of The International Consortium on Ehlers-Danlos Syndromes and Hypermobility Spectrum Disorders, and through its global registry.