Clinical stage biopharmaceutical company Protalex has begun screening patients at sites in the U.S. for its new multicenter,Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 in adults with active rheumatoid arthritis (RA). Protalex is focused on the development of a class of drugs designed to treat autoimmune and inflammatory diseases including rheumatoid arthritis.
The primary objective of this Phase 1b study of PRTX-100 will be to further assess the safety and tolerability of intravenous PRTX-100 administered weekly over 5 weeks in patients with active rheumatoid arthritis on methotrexate therapy.
The secondary objectives include determining the effects of PRTX-100 on measures of disease activity, assessing the immunogenicity and evaluating the pharmacokinetic (PK) parameters after repeated doses, and determining possible relationships between the immunogenicity of PRTX-100 and safety, PK and efficacy parameters.
The sequential dose escalation phase of this Phase1b study will randomize up to 40 patients into the dose escalation cohorts starting at 1.50 ug/kg PRTX-100 or placebo, followed by up to 12 additional randomized patients for cohort expansion.
Enrollment is expected to take place at study sites in both the U.S. and South Africa.