BioVie Inc. (NASDAQ: BIVI) announced the appointment of two industry veterans to its Board of Directors as the clinical-stage company advances multiple neurological and liver disease programs through Phase 2 development. Amy S. Chappell, MD, FAAN, and Kameel D. Farag join the board as BioVie continues Phase 2 trials of bezisterim for early Parkinson's disease and long COVID.
"Amy and Kameel each bring an extraordinary combination of strategic vision, operational excellence, and hands-on experience developing and commercializing therapies in complex neurological and chronic diseases," said Cuong Do, President and Chief Executive Officer of BioVie Inc. "As BioVie continues to advance bezisterim through Phase 2 trials for early Parkinson's disease and long COVID, and plans the next steps in clinical development in our Alzheimer's disease and ascites programs, their expertise will be invaluable in achieving our mission of transforming the treatment of these devastating conditions."
Clinical Neuroscience Leadership
Dr. Chappell brings decades of experience in clinical neuroscience and drug development from her 25-year career at Eli Lilly & Co., where she played a central role in developing and gaining US Food and Drug Administration (FDA) approvals for multiple central nervous system (CNS) indications, including for Cymbalta® in fibromyalgia and musculoskeletal pain. She later served as Chief Medical Officer (CMO) for Eliem Therapeutics, assisting it through a successful initial public offering (IPO) and advancing programs in epilepsy and mood disorders.
Currently serving as CMO of Solaxa Inc., Dr. Chappell oversees clinical development of novel therapies for ataxia and nerve repair. She holds numerous patents, has authored over 100 peer-reviewed publications and presentations, and remains a Fellow of the American Academy of Neurology.
Financial and Operational Expertise
Mr. Farag brings proven biotech and global finance experience with a track record of scaling companies through transformational growth. Most recently, as Chief Financial Officer (CFO) and head of business operations at Aspen Neuroscience, he oversaw tripling the company's headcount, secured over $150 million in financing, built manufacturing infrastructure, and prepared the company for clinical data and a potential future public offering.
He previously served as SVP of Finance at Ionis Pharmaceuticals, and Regional CFO for Amgen's international business, where he helped expand ex-US presence, double regional revenues and build global operational capabilities. His strategic leadership and capital markets expertise will help guide BioVie through its next phase of development.
Advancing Multiple Clinical Programs
The appointments come at a time of growing momentum for BioVie. The Company recently published and presented promising data on bezisterim's potential to slow or reverse biological aging and neurodegeneration at the 7th World Aging and Rejuvenation Conference. BioVie also recently initiated its ADDRESS-LC Phase 2 long COVID trial and continues to drive patient-focused clinical innovation with the SUNRISE-PD Parkinson's study.
BioVie's drug candidate bezisterim inhibits inflammatory activation of extracellular signal-regulated kinase and the transcription factor nuclear factor-κB, and the associated neuroinflammation and insulin resistance but not ERK and NFκB homeostatic functions such as insulin signaling and neuron growth and survival. Both neuroinflammation and insulin resistance are drivers of Alzheimer's disease and Parkinson's disease, while persistent systematic inflammation and neuroinflammation are key features in patients with neurological symptoms of long COVID.
Liver Disease Program Development
In liver disease, the Company's Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the reduction of further decompensation in participants with liver cirrhosis and ascites. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis.
