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Aytu BioPharma Announces FDA Clearance of Investigational New Drug (IND) Application for AR101/Enzastaurin in Vascular Ehlers-Danlos Syndrome
Pivotal clinical trial will begin in first half of 2022ENGLEWOOD, CO / ACCESSWIRE / December 13, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU), a pharmaceutical
About this update from Aytu Biopharma, Inc.
[{"type":"text","content":"Pivotal clinical trial will begin in first half of 2022ENGLEWOOD, CO / ACCESSWIRE / December 13, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU), a pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has cleared the IND application for AR101/enzastaurin, enabling the company to proceed with initiating a pivotal clinical trial for AR101 in vascular Ehlers-Danlos Syndrome (VEDS). The company plans to initiate the PREVEnt Trial in VEDS in the first half of 2022. The PREVEnt Trial will assess the safety and efficacy of enzastaurin in COL3A1-confirmed VEDS patients. There are currently no FDA-approved therapies for VEDS.\"The FDA's clearance of the AR101 IND is a significant milestone for VEDS patients and the rare disease community at large as we move one step closer to initiating the PREVEnt Trial,\" said Josh Disbrow, chief executive officer of Aytu BioPharma. \"This clearance enables us to initiate this important study in VEDS, a life-shortening genetic disease for which there is no approved treatment. The entire Aytu BioPharma team is committed to initiating this pivotal trial as quickly as possible. We thank our scientific advisory board and clinical and regulatory advisors in helping us get to this point so quickly. We're now positioned to start the PREVEnt Trial in the first half of 2022 and look forward to taking that next step for the benefit of these patients in need of a new treatment for this catastrophic disease.\"About vascular Ehlers-Danlos Syndrome (VEDS)Vascular Ehlers Danlos Syndrome (VEDS) is the severe subtype of Ehlers-Danlos Syndrome, affecting 1 in 50,000 people worldwide and results from pathogenic variants in the COL3A1 gene, which encodes the chains of type III procollagen, a major protein in vessel walls and hollow organs. VEDS is typically diagnosed in childhood and is characterized by arterial aneurysm, dissection and rupture, bowel rupture and rupture of the gravid uterus. Twenty-five percent of VEDS patients have a first complication by the age of 20 years, and more than eighty percent have at least one complication by the age of 40. VEDS is a devastating condition, and VEDS patients have a median lifespan of 51 years.About AR101 (enzastaurin)AR101 (enzastaurin) is an orally available investiga...