Principia Announces AAD Late Breaker Research Presentation of its Pemphigus Phase 2 Part B Trial

SOUTH SAN FRANCISCO, Calif., May 12, 2020 (GLOBE NEWSWIRE) -- Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing treatments for immune mediated diseases, today announced an upcoming full data set presentation from the Phase 2 Part B pemphigus trial with its investigational drug rilzabrutinib. Dr. Dedee Murrell, professor and Head of the Department of Dermatology at The St. George Hospital Clinic School, University of New South Wales in Sydney, will present results from this open-label BELIEVE-PV trial during the virtual Late-breaker Research session of the American Academy of Dermatology (AAD), June 12-14. All AAD sessions will be available on-demand beginning Friday, June 12 at 3 p.m. Eastern time at . 

About rilzabrutinib

Rilzabrutinib, Principia’s most advanced drug candidate, is an oral, small molecule, reversible covalent inhibitor of Bruton’s tyrosine kinase (BTK), which is present in the signaling pathways of most types of white blood cells except for T cells and plasma cells. Rilzabrutinib was designed based on Principia’s proprietary Tailored Covalency^® platform to optimize rilzabrutinib’s safety and efficacy profile, resulting in prolonged and reversible action at the target site while being rapidly eliminated from the body. Principia believes this approach limits systemic exposure of rilzabrutinib and enables rapid clinical reversibility of effects on the immune system and is thus designed for use as a chronic therapy in immune-mediated diseases.

About Principia Biopharma

Principia is a late-stage biopharmaceutical company dedicated to bringing transformative therapies to patients with significant unmet medical needs in immune-mediated diseases. Through Principia’s proprietary Tailored Covalency^® platform, our strategy is to build and advance a pipeline of best-in-class drug candidates with significant therapeutic benefits, limit unintended side effects, improve quality of life and over time modify the course of disease. This highly reproducible approach enables the company to pursue multiple programs efficiently, having discovered three drug candidates. Rilzabrutinib, a reversible covalent BTK inhibitor, is being evaluated in a global Phase 3 clinical trial in participants with pemphigus, a Phase 1/2 clinical trial in participants with immune thrombocytopenia (ITP), and the company plans to initiate a Phase 2 clinical trial in participants with IgG4-Related Diseases. PRN2246/SAR442168 is a covalent BTK inhibitor which crosses the blood-brain barrier and is partnered with Sanofi. Sanofi has announced that PRN2246/SAR442168 will be evaluated in four Phase 3 clinical trials in participants with relapsing and progressive forms of multiple sclerosis. PRN473 Topical, a topical reversible covalent BTK inhibitor designed for immune mediated diseases that could benefit from localized application to the skin, is being evaluated in a Phase 1 trial. For more information, please visit .

Forward-Looking Statements

This press release contains forward-looking statements. These forward-looking statements reflect the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Principia’s expectations regarding the Principia pipeline of product candidates, the potential of rilzabrutinib to rapidly and effectively treat pemphigus while significantly reducing the exposure to moderate to high CS doses, the safety and efficacy of rilzabrutinib,, the timing, scope and success of additional clinical results (including, without limitation, the final results from Part B of the Phase 2 trial), and the planned presentation of Phase 2 Part B results at the virtual AAD meeting. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause Principia’s actual results, performance, or achievements to be materially different from those expressed or implied by the forward-looking statements. For a description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Principia’s business in general, see the risk factors set forth in Principia’s reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Principia specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.