Principia Announces Update to Ongoing Phase 2 Clinical Trial in Patients with ITP
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 – 200mg once-a-day, 400mg once-a-day, 300mg twice-a-day and 400mg 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/
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 and results from its current clinical trials. 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 the Principia’s business in general, see the risk factors set forth in Principia’s reports filed with the
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Source: Principia Biopharma Inc.