Benzinga | Sep 9, 2021 08:11AM EDT

Aytu BioPharma Announces Formation Of New Scientific Advisory Board To Support Development Of AR101 For Vascular Ehlers-Danlos Syndrome

Aytu BioPharma, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, today announced the formation of its Scientific Advisory Board, chaired by Dr. Hal Dietz, Professor of Genetic Medicine at the Johns Hopkins University School of Medicine. Other initial members of the SAB include Dr. Xavier Jeunemaitre, Professor of Genetics at University Paris Descartes, Dr. Shaine Morris, Medical Director of Cardiovascular Genetics at Texas Children's Hospital and Associate Professor at Baylor College of Medicine, Dr. Bart Loeys, Professor at the Center for Medical Genetics of the Antwerp University Hospital and Radboud University Medical Center in Nijmegen, and Dr. Peter Byers, Professor in the Department of Laboratory Medicine and Pathology and Department of Medicine (Medical Genetics) at the University of Washington. These prominent physicians will advise Aytu BioPharma to advance the global development of AR101 (enzastaurin), a pivotal study-ready therapeutic candidate initially targeting the treatment of Vascular Ehlers-Danlos Syndrome (VEDS). VEDS is a rare genetic disorder typically diagnosed in childhood and characterized by arterial aneurysm, dissection and rupture, bowel rupture and rupture of the gravid uterus. There are currently no U.S. Food and Drug Administration (FDA)-approved treatments for VEDS.

"We are honored to have our chair, Dr. Hal Dietz, as well as our key advisors Dr. Xavier Jeunemaitre, Dr. Shaine Morris, Dr. Bart Loeys, and Dr. Peter Byers join this newly formed SAB. Their collective expertise will prove invaluable as we progress toward a single pivotal study of AR101 in VEDS and seek strategies to minimize the clinical risk associated with the trial and hopefully advance this novel potential treatment option so that we can positively impact patients diagnosed with this devastating disease," commented Josh Disbrow, Chief Executive Officer of Aytu BioPharma. "We look forward to adding additional key opinion leaders to the SAB to lend their expertise to the development of AR101 in VEDS."

Hal Dietz, M.D. - Chairman of the Scientific Advisory Board

Dr. Dietz conducted the landmark research to date supporting AR101 in VEDS. He is Victor A. McKusick Professor of Pediatrics, Medicine, and Molecular Biology & Genetics in the Department of Genetic Medicine at the Johns Hopkins University School of Medicine and an Investigator at the Howard Hughes Medical Institute. As a physician scientist, he has dedicated his entire career tothe care and study of individuals with heritable connective tissue disorders with primary perturbations of extracellular matrix homeostasis and function. His lab has identified the genes for many of these conditions, for which he uses model systems to elucidate disease mechanisms. Dr. Dietz has received multiple prestigious awards including the Curt Stern Award from the American Society of Human Genetics, the Colonel Harland Sanders Lifetime Achievement Award in Medical Genetics, the Taubman Prize for excellence in translational medical science, the Harrington Prize from the American Society for Clinical Investigation and the Harrington Discovery Institute, the Pasarow Award in Cardiovascular Research, the InBev-Baillet Latour Health Prize from the country of Belgium, and the Research Achievement Award from the American Heart Association. He is an inductee of the American Society for Clinical Investigation, American Association for the Advancement of Science, Association of American Physicians, National Academy of Medicine, and National Academy of Sciences.

Xavier Jeunemaitre, M.D., Ph.D.

Dr. Jeunemaitre is Professor of Genetics at University Paris Descartes, the Head of the Department of Genetics at the Hospital Pompidou (HEGP) and the Director of the INSERM research team 3, U970, at the Paris Cardiovascular Research Centre, Paris, France. Dr. Jeunemaitre received his M.D. and Ph.D. in human genetics at the University P&M Curie, Paris, France. He was trained as an internist and specialized in cardiology before training in molecular genetics at the College de France in Paris and in human genetics during a post-doctoral fellowship at the Institute of Human Genetics, Salt Lake City, University of Utah, USA. Dr Jeunemaitre is the head of the National Referral Centre for Rare Vascular Diseases at HEGP which provides advice and care for more than 1,000 patients a year and is involved in epidemiological surveillance, registries, and clinical research. His laboratory of molecular genetics at HEGP provides genetic testing for rare cardiovascular and renal diseases as well as endocrine cancers (conducting approximately 2,500 tests a year).

Shaine A. Morris, M.D., M.P.H.

Dr. Morris is a pediatric cardiologist and Medical Director of the Cardiovascular Genetics Program at Texas Children's Hospital and Associate Professor at Baylor College of Medicine. Dr. Morris received her M.D. at University of Texas Southwestern Medical Center and M.P.H. at Harvard School of Public Health. She trained in pediatrics at Boston Children's Hospital and Boston Medical Center, followed by cardiology training at Texas Children's Hospital/Baylor College of Medicine and advanced cardiovascular imaging at Boston Children's Hospital. The Cardiovascular Genetics Program provides comprehensive diagnosis, counseling, and cardiovascular management for young people with genetic conditions and cardiovascular disease, specifically focusing on genetic conditions affecting the aorta and other arteries. Dr. Morris' research interests align with her clinic interests and focus primarily on improving outcomes for the young population with genetically-mediated aortic disease. Specifically, she performs epidemiologic and clinical outcomes research involving cardiovascular imaging, molecular diagnostics, and deep phenotyping to improve risk stratification and optimize therapies based on individual patient characteristics.

Bart Loeys, M.D., Ph.D.

Dr. Loeys is professor of medical genetics and cardiogenomics at the Center for Medical Genetics of the Antwerp University Hospital in Belgium and in the department of Human Genetics in the Radboud University Medical Center in Nijmegen, The Netherlands. He trained as a pediatrician in Ghent, Belgium and as a clinical geneticist in the McKusick-Nathans Institute for Genetic Medicine at the Johns Hopkins University Hospital in Baltimore, Maryland. His special interests include connective tissue disorders, specifically heritable aortic aneurysm syndromes. He obtained a medical degree at the Ghent University in 1995 and subsequently started a pediatric residency training at the Ghent University Hospital. During this training program (1998-2002), he combined clinical and research activities and worked as a junior clinical investigator of the Fund for Scientific Research-Flanders in the Center for Medical Genetics of the Ghent University. His research project, entitled "Genotype and phenotype study of inherited defects of the elastic fiber," resulted in a PhD degree of Doctor in Medical Sciences (2004). From 2002 to 2005, he was accepted into the fellowship program in medical genetics of the Johns Hopkins Medical Institute. Together with his colleague, Dr. Hal Dietz from the Johns Hopkins University, he identified a new aortic aneurysmal disorder, now called Loeys-Dietz syndrome. At the end of his fellowship, he successfully obtained the certification for clinical genetics from the American Board of Medical Genetics. Since 2005, upon his return to Belgium, he has been a senior clinical investigator of the fund for scientific research - Flanders, initially in the Center for Medical Genetics-Ghent and since December 2010 in the Center for Medical Genetics of the University Hospital in Antwerp with a joint appointment at the Radboud University Medical Center in Nijmegen. Over the years he became an internationally renowned expert in the genetic basis of aortic aneurysmal disease. He was recently awarded the Francqui-Collen Prize, the so-called Belgian Nobel prize for translational biomedical research.

Peter Byers, M.D.

Dr. Byers is a board-certified physician with the Genetic Medicine Clinic and Center on Human Development and Disability and Pathology Services at University of Washington Medical Center and a University of Washington professor of Medicine, Pathology and Medical Genetics and an adjunct professor of Genome Sciences and Oral Health Sciences. Dr. Byers' philosophy is "get it right the first time." His research has the objective of understanding the molecular pathogenesis of inherited disorders of connective tissue. Dr. Byers earned his M.D. at Case Western Reserve University in Cleveland, Ohio. He is board certified in both Internal Medicine and Clinical Genetics. His research has focused on disorders that affect collagen genes and the enzymes involved in the post-translational modification of collagens.