ExesaLibero Pharma is dedicated to developing new small molecule drugs to treat bone disease.

Company

Extensive Experience. Specialized Insights. Focused Outcomes.

The primary mission ExesaLibero Pharma, Inc is to complete the vital preclinical toxicology and efficacy studies for a groundbreaking small-molecule drug. This extraordinary innovation holds the key to controlling the insidious bone erosion that plagues numerous debilitating diseases, such as rheumatoid arthritis, multiple myeloma, diabetes, periodontal disease, and tuberculosis. By tackling this critical issue head-on, we aim to enhance the lives of countless individuals afflicted by these disease conditions. The results of these studies will form the bases for an Investigative New Drug (IND) application to the Food and Drug Agency (FDA). Following the approval of the IND by the FDA, we expect to initiate clinical trials that will lead to full approval of the drug for clinical use.

Management

John Barnett, Ph.D.
President, and Chief Scientific Officer
Cecilia Barnett, MSN
Vice President, Director of Human Resources
Spilman Thomas & Battle, Charleston, WV
Legal Counsel
Baker Tilly, Morgantown, WV
Accounting
Jamie McCall, Ph.D.
Chief Scientist

Board of Directors

Allie Karshenas, Ph.D., Board Chair
WVU Assoc. VP of Clinical Operations & Institutional Advancement, Associate VP of Global Engagement, Assoc. Professor, School of Pharmacy
Richard Goldberg, M.D.
WVU Cancer Institute Director (Emeritus), Professor (Emeritus) Dept Medicine, WVU School of Medicine
Erik L. Hewlett, M.D.
Professor Emeritus, Departments of Medicine (Division of Infectious Diseases and International Health) and Microbiology, Immunology and Cancer Biology, University of Virginia School of Medicine
Paul Lockman, Ph.D.
WVU Assistant Vice President of Experimental Therapeutics, Professor, Benedum Fellow, and the Mylan Endowed Chair, School of Pharmacy
Colleen Watkins, M.D.
Assoc. Professor, Dept. of Orthopaedics; Board Certified in Internal Medicine and Rheumatology
John Barnett, Ph.D., ex officio (non-voting)
ExesaLibero President & Chief Scientific Officer; West Virginia University (WVU) Emeritus Professor & Chair, Dept. of Microbiology, Immunology & Cell Biology

Scientific Advisory Board

John Barnett, Ph.D., Chair
Founding member – ExesaLibero President and Chief Scientific Officer; Emeritus Professor & Chair of the Dept of Microbiology, Immunology & Cell Biology, West Virginia University (WVU) School of Medicine. Research focus: immunotoxicology, inflammation, T cell biology
Mariette Barbier, Ph.D.
Associate Professor and Chair, Department of Microbiology, Immunology and Cell Biology, WVU. Research Focus: Microbial Pathogenesis
Harry Blair, M.D.
Founding member – Univ. of Pittsburgh Professor of Pathology; Board Certified in Anatomic and Clinical Pathology. Research Focus: bone biology
Matthew Dietz, M.D.
Professor and Chair, Department of Orthopaedics, WVU. Research Focus: Novel techniques for remediation of Implant-associated, prosthetic joint, and open fracture infections
Werner Geldenhuys, Ph.D.
Member - WVU School of Pharmacy; Professor; Research focus: pharmacotherapeutics
Jamie McCall, Ph.D.
Chief Scientist at ExesaLibero; Adjunct Research Assistant Professor, West Virginia University. Research Focus: molecular biology, cancer cell biology and immunobiology
Jonathan Soboloff, Ph.D.
Founding member – Professor and Associate Director, Division of Genetic, Environmental and Inhalational Disease, Department of Internal Medicine, Univ of Kansas Medical Center
Bjorn Soderberg, Ph.D.
Member –WVU Dept of Chemistry; Professor, Emeritus; Research Focus: synthesis of biologically active products

Product & Technology

Creating a new targeted and versatile treatment for bone erosion

The company is working on a new approach to treating bone erosion based on a common pathway in the cell that infiltrates bone and joints. Bone erosion disables millions of people each year. It occurs in children and adults with cancer, after trauma and infections, but most cases are idiopathic. A prime idiopathic example is the millions of adults who live with chronic RA. Patients with multiple myeloma suffer from painful bone lesions caused by cancer-induced overproduction of the cell that normally controls bone development.

Bone lesions often require treatments with serious side effects. Later in arthritis, bone erosion is a major problem that causes severe pain and debilitation. There is no small-molecule drug available to treat arthritis bone erosion specifically. Bisphosphonates used for multiple myeloma patients to control bone lesions have severe side effects. We show that osteoclast maturation is suppressed by blocking ion channels. Our leading drug candidate, ion-channel antagonist ELP-004, suppresses osteoclast maturation and strongly suppresses bone erosion in two mouse models of arthritis, even after symptoms of arthritis were measurable, and prevents bone lesions from developing with multiple myeloma in mice.

We hypothesize that signals mediated by specific ion channels modulate the final differentiation of osteoclasts resulting in bone and joint degradation. We propose that pharmacologically suppressing specific ion channels with ELP-004 will prevent bone erosion due to idiopathic and pathologic stimuli without major adverse effects. Preclinical toxicity assays show that ELP-004 has minimal toxicity to the immune and cardiovascular systems and has no measurable genotoxicity. Continued comprehensive pharmacokinetic and toxicokinetic testing, in addition to mechanistic experiments with ion-channel signaling, immunology, and bone biology expertise, is underway.