LA JOLLA, Calif.--(BUSINESS WIRE)--Arialys Therapeutics, a clinical-stage biotechnology company pioneering new precision medicines for autoimmune neuropsychiatry, today announced the appointment of Sankalp “Sam” Gokhale, M.D., as Chief Medical Officer. Dr. Gokhale is a U.S. board-certified neurologist with over 15 years of clinical practice and pharmaceutical industry experience. He has extensive expertise in all phases of clinical development, specifically in rare disease neurology indications.
“I am delighted to welcome Sam to the team. As a board-certified neurologist specializing in neurological critical care and a clinical trialist focused on rare, autoimmune neurology diseases, Sam brings a wealth of experience to Arialys,” said Peter Flynn, Ph.D., President and CEO of Arialys Therapeutics. “Sam joins us on our transition to a clinical-stage company, and his extensive experience running global clinical studies at all stages of development, and interacting with regulatory authorities, will be vital as we pursue clinical proof-of-concept for our lead therapeutic candidate, ART5803.”
“I am excited to join the Arialys team and help drive the development of ART5803, a first-in-class precision medicine for the treatment of autoimmune neuropsychiatric disease,” said Dr. Gokhale. “There are currently no approved therapies for anti-NMDA receptor encephalitis, and emerging but compelling data suggest that autoantibodies are a component of broader psychosis indications such as schizophrenia, schizoaffective disorder, as well as dementia.”
Dr. Gokhale brings experience in building clinical development and medical functions, extensive interactions with global regulatory authorities in the rare auto-immune neurology space, and robust networks of global key opinion leaders. He most recently served as Senior Vice President, Head of Clinical Development at Dianthus Therapeutics, where he led global clinical studies assessing a therapeutic monoclonal antibody in myasthenia gravis, multifocal motor neuropathy, and chronic inflammatory demyelinating polyneuropathy. Prior to Dianthus, Sam held roles in clinical development with progressively increasing responsibilities at Radius Health, leading the clinical development of oral CBD for multiple rare neuropsychiatric and epilepsy indications; and at Alexion Pharmaceuticals, leading multiple Phase 2 and 3 global clinical trials (pediatric and adult) for eculizumab and ravulizumab in myasthenia gravis, with U.S. FDA approval of ravulizumab in myasthenia gravis.
After attending medical school in Mumbai, India, Dr. Gokhale completed his neurology residency at Beth Israel Deaconess Medical Center / Boston Children's Hospital at Harvard Medical School and a fellowship in neurological critical care at Duke University Medical Center and received his M.B.A. from the University of Arizona. Dr. Gokhale was instrumental in building the successful neurocritical care program at the Banner - University Medical Center in Tucson, Arizona prior to transitioning to the biopharmaceutical industry.
About ANRE and ART5803
Anti-NMDA receptor encephalitis (ANRE) is a rare, potentially lethal, poorly managed and often misdiagnosed neurological disease. ANRE is caused by pathogenic autoantibodies that bind NMDA receptors (NMDAR), resulting in loss of function and rapid onset of a range of symptoms including psychiatric and behavioral alterations, cognitive decline, seizures and diminished autonomic function. A significant percentage of ANRE patients are pediatric where NMDAR specific autoantibodies can also result in neurological development deficits. Recent findings have also identified anti-NMDAR autoantibodies in other neuropsychiatric diseases such as schizophrenia and dementia. Arialys has used co-crystallographic structural analysis of the autoantibody-NMDAR interaction to design a precision medicine approach to the treatment of neuropsychiatric disease. ART5803 is a clinical-stage therapeutic antibody that competitively blocks the pathogenic autoantibodies and rescues NMDAR function. Arialys has generated compelling preclinical data in higher disease models confirming ART5803 rapidly reverses the behavioral symptoms caused by NMDAR autoantibody pathogenicity in the brain. Arialys has received Orphan Drug Designation from the U.S. FDA for ART5803.
About Arialys Therapeutics
Arialys was founded to meaningfully expand the treatment possibilities for neuropsychiatric disorders driven by autoimmune disease. Using a combination of highly sensitive autoantibody detection, patient sampling and receptor structural biology, Arialys has developed a first-in-class precision therapy to specifically block pathogenic autoantibodies in the brain. Arialys is headquartered in La Jolla, California. For more information, visit www.arialysrx.com.
