Principia Announces Update to Ongoing Phase 2 Clinical Trial


Principia Biopharma Inc. recently announced updates to its immune thrombocytopenia (ITP) program for PRN1008. The ongoing open-label, dose-finding clinical trial investigating PRN1008 in patients with ITP who are refractory or relapsed with no available treatment options, was designed to test safety and activity across multiple doses – 200 mg once-a-day, 400 mg once-a-day, 300 mg twice-a-day, and 400 mg twice-a-day. The protocol has been modified to add a long-term extension cohort for responders and, if needed, to enroll additional patients to inform the design of the Phase 3 program. The company plans to announce top-line data from this trial during the fourth quarter of 2019.

Principia is a late-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology. Principia’s proprietary Tailored Covalency platform differentiates the company’s investigational therapies from traditional small molecules and provides the potential to deliver the potency, selectivity, and safety of injectable drugs while maintaining the convenience of a pill. This highly reproducible approach enables the company to pursue multiple programs efficiently. PRN1008, a reversible covalent BTK inhibitor, is being evaluated in a Phase 3 clinical trial in patients with pemphigus, an orphan autoimmune disease, and in a Phase 2 clinical trial in patients with immune thrombocytopenia, a rare hematological disease. PRN2246/SAR442168, a covalent BTK inhibitor which crosses the blood-brain barrier, has commenced a Phase 2 clinical trial in patients with multiple sclerosis, and has been partnered with Sanofi. PRN1371, a covalent inhibitor of Fibroblast Growth Factor Receptor (FGFR) is being evaluated in a Phase 1 trial in patients with bladder cancer. For more information, visit www.principiabio.com.

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