Parvus Therapeutics Has Received Orphan Drug Designation for Primary Biliary Cholangitis and Human Research Ethics Committee Approval to Begin Clinical Testing

South San Francisco, CA, July 29, 2024 --(PR.com)-- Parvus Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PVT201 for the treatment of Primary Biliary Cholangitis (PBC) and PVT201 has obtained Australian Human Research Ethics Committee (HREC) approval to initiate a first-in-human Phase I clinical trial.

“Orphan Drug Designation and HREC approval are the latest development milestones which represent significant progress and de-risking of our plans for a first-in-human clinical study start later in 2024,” said Peter Strumph, CEO of Parvus Therapeutics. “Continued product development progress brings us closer to fulfilling our mission to cure autoimmune disease.”

Parvus is developing products based on the novel Navacim™ platform technology which triggers endogenous generation of antigen-specific regulatory T-cells (Tregs) with the potential to halt and cure autoimmune disease by restoring organ specific immune tolerance without compromising normal immunity to infections and cancer. Parvus' lead Navacim (PVT201) has shown disease modification and hepatoprotection in preclinical models of Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC), and Autoimmune Hepatitis (AIH). Parvus' second Navacim (PVT401) for Inflammatory bowel disease (IBD) is being developed by Parvus in partnership with AbbVie. Parvus has additional Navacim development programs for Type 1 Diabetes, Multiple Sclerosis, Rheumatoid Arthritis, transplant rejection, and Celiac Disease.

FDA Orphan Drug Designation is granted to investigational drugs addressing rare medical diseases that affect fewer than 200,000 people in the United States and, for preclinical drugs, show compelling mechanistic and disease model data that demonstrate promise to treat the disease. Orphan drug status provides benefits to drug developers, including tax credits, exemptions from certain FDA fees and post-approval marketing exclusivity.