Principia Biopharma Inc, a clinical-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology, today announced positive top-line data from the completed open-label Phase 2 trial of PRN1008 in patients with pemphigus (including both pemphigus vulgaris (PV) and pemphigus foliaceus (PF)) and the initiation of a Phase 3 trial of PRN1008 in pemphigus. The primary efficacy endpoint of the Phase 2 trial – Control of Disease Activity (CDA) within four weeks – was achieved by more than 50% of patients and PRN1008 was generally well tolerated. Based on the results of the Phase 2 trial, Principia has initiated the PEGASUS study, a global, randomized, double-blind, placebo-controlled, pivotal, Phase 3 clinical trial of PRN1008 in patients with moderate to severe pemphigus.
“Pemphigus is a debilitating disease with high unmet need. We are encouraged by the efficacy and safety results from the Phase 2 trial and are initiating the Phase 3 trial based on these results. This is a key milestone for Principia, and the next step toward bringing this novel oral therapy to patients in need,” said Martin Babler, Chief Executive Officer of Principia.
“PRN1008 has the potential to effectively treat patients’ disease and significantly reduce dependence on harmful corticosteroid (CS) doses, which have been the mainstay of treatment in this disease, and may usher in a new era of steroid-sparing, oral therapy for patients suffering from the disease,” stated Dr. Dedee Murrell, Professor and Head of the Department of Dermatology at The St. George Hospital Clinical School, University of New South Wales in Sydney, Australia and the lead principal investigator.
The full data from the Phase 2 trial will be submitted for presentation at a future scientific conference.