Access to Investigational Drugs Policy
Protagonist is a clinical-stage biopharmaceutical company committed to developing novel peptide-based drugs to address significant unmet medical needs and making them available broadly to patients as quickly as possible by conducting the clinical trials necessary to gain approval by regulatory authorities. We have five novel peptidic assets currently in different stages of clinical studies. Rusfertide (PTG-300) is a hepcidin mimetic currently being studied as a treatment for polycythemia vera (PV) and hereditary hemochromatosis (HH). PN-943 is an α4β7 integrin-specific antagonist being studied in patients with moderate-to-severely active ulcerative colitis (UC). PTG-200 is an oral IL-23 receptor antagonist being studied for Crohn’s disease (CD). In October 2020, we announced the selection of two second-generation IL-R antagonists for advancement into clinical development, PN-235 (also referenced as JNJ-77242113) and PN-232 (also referenced as JNJ-75105186).
This reflects our corporate policy on providing access to our new investigational medicines before they are fully approved for use on prescription.
While Protagonist recognizes that there may be a possible need for patients to gain early access to a new investigational therapy, our new medicines are currently in the early stages of clinical development with limited information concerning their safety and efficacy and limited supplies available. Therefore, Protagonist does not currently have an expanded access program pursuant to section 561(b) of the U.S. Federal Food, Drug, and Cosmetic Act. We believe that the best way to gain access to our investigational therapies is by participating in one of our clinical studies. For more information concerning clinical studies currently being conducted by Protagonist, please contact firstname.lastname@example.org.
For any additional questions concerning this policy or our studies please contact email@example.com.