Responsible for managing clinical development and the regulatory processes for ATI-2173, an ASPIN, which is in development as part of a potential curative regimen for chronic hepatitis B infection
MENDHAM, N.J., April 27, 2021 (GLOBE NEWSWIRE) – Antios Therapeutics, Inc. (“Antios”) today announced the appointments of two experienced drug development executives, Katie Laessig, M.D., as Senior Vice President, Global Regulatory Affairs, and Karen Fusaro as Senior Vice President, Clinical Operations. These appointments add significant depth to the Company’s drug development team, which is focused on the clinical development of ATI-2173, an Active Site Polymerase Inhibitor Nucleotide (ASPIN), for the treatment of patients with chronic hepatitis B virus (HBV) infection. Both will report to Douglas Mayers, M.D., Chief Medical Officer of Antios.
“With the completion of our Phase 1b clinical trial of ATI-2173 in chronic HBV-infected patients, the recent initiation of SAVE-1 and expected late-stage clinical trials in coming years, we have been looking to add further clinical and regulatory expertise to our drug development team,” said Gregory Mayes, Chief Executive Officer of Antios. “Karen and Katie bring extensive experience in leading clinical operations and managing regulatory processes. We welcome both to the Antios leadership team.”
Dr. Laessig has more than 20 years of experience in pharmaceutical regulatory roles both in industry and for the U.S. FDA. Before joining Antios, she served as Vice President, Therapeutic Strategy, Strategic Drug Development at IQVIA where she delivered strategic regulatory and clinical development planning for pharmaceuticals and biologics, including support for regulatory interactions, across a range of therapeutic areas for the IQVIA’s biotechnology and pharmaceutical customers. Before that, she was SVP, Regulatory Affairs, Medical Safety and Quality Assurance at RRD International, LLC, where she provided strategic and tactical regulatory, clinical, and development evaluation and direction to product development programs undertaken by RRD for its client companies. From 1999 to 2015, Dr. Laessig served in multiple roles of increasing responsibility at the U.S. FDA including Medical Review Officer and Medical Team Leader, Division of Antiviral Products, and Deputy Director, Division of Anti-Infective Products. From 2000-2016, she volunteered once weekly at the Whitman Walker Clinic in Washington, DC, the city’s largest provider of HIV/AIDS care. Dr.Laessig earned her M.D. from the University of Maryland School of Medicine and a B.A. in Biology from Cornell University.
“From my years of clinical experience, and time at FDA and consulting with biopharmaceutical clients, I have witnessed both the critical need of patients suffering from viral diseases as well as the industry response through drug development and how regulators evaluate these potential therapies,” said Dr. Laessig. “Joining Antios is a great opportunity for me to leverage my expertise to guide ATI-2173 through the regulatory process toward eventual approval.”
Ms. Fusaro spent more than 20 years managing and leading execution of clinical trials from Phase 1 through Phase 3 in several therapeutic areas including infectious disease. Prior to joining Antios, she held several positions of increasing responsibility at Melinta Therapeutics where she oversaw all clinical, regulatory and pharmacovigilance activities for four antibiotic programs. Before that, she was responsible for clinical operations and clinical project management at The Medicines Company and contributed to the U.S. Food and Drug Administration (FDA) approvals of two antibiotics, ORBACTIV® and VABOMERE®. Additional experience included managing global clinical development of diabetes and cardiovascular programs at Novartis and managing global clinical trials for neuropathic pain, HIV, liver fibrosis and migraine candidates for GlaxoSmithKline. Ms. Fusaro earned a B.A. in Psychology from State University of New York at Binghamton.
“Antios is developing a drug candidate that could change the paradigm for treating patients with chronic HBV infection,” said Ms. Fusaro. “I look forward to working with the team to design and execute a clinical program that both optimizes trial success and supports the objective of developing a curative regimen for chronic HBV.”
ATI-2173 is a novel, orally administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) molecule designed to deliver the 5’-monophosphate of clevudine to the liver where it is metabolized to the active 5’-triphosphate. This L-nucleoside’s active 5’-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor that distorts the active site of HBV polymerase resulting in potent HBV antiviral activity and extended off-treatment suppression of HBV DNA. ATI-2173 targets the liver, delivering high levels of the unique 5’- triphosphate while limiting systemic exposure to the parent L-nucleoside. ATI-2173 has the potential to become an integral part of a curative combination regimen for chronic hepatitis B.
About Antios Therapeutics Inc.
Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Antios is currently developing ATI-2173, aiming to provide chronic hepatitis B infected patients with a curative combination regimen.