Business
Protagonist Therapeutics Reports First Quarter Financial Results and Provides Corporate Update
-- Company selects the polycythemia vera indication for pivotal development of PTG-300 based on robust clinical responses -- -- Revised and focused
About this update from Protagonist Therapeutics, Inc.
[{"type":"text","content":"-- Company selects the polycythemia vera indication for pivotal development of PTG-300 based on robust clinical responses --\n -- Revised and focused development plans now provide sufficient capital to fund operations through mid-2022 --\n -- Protagonist to host a conference call today to provide a corporate update, and details of initial Phase 2 polycythemia vera results to be presented by Ronald Hoffman, M.D., Director of the Myeloproliferative Diseases Program at The Icahn School of Medicine at Mount Sinai --\n\n\nNEWARK, Calif., May 7, 2020 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today reported its financial results for the first quarter ended March 31, 2020, and provided an update on clinical development programs.\n\n \n \n \n \n \n \n\n \n\"Based on the highly promising and consistent clinical responses achieved to date, we are pleased to announce polycythemia vera as the first indication for a pivotal study of PTG-300,\" commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. \"With an orphan drug development regulatory path forward, we are focused on rapidly advancing PTG-300 as a first-in-class non-cytoreductive hepcidin hormone mimetic agent for this indication with significant unmet need. With a highly focused development effort forward with PTG-300 for polycythemia vera, and deferring PN-943 Phase 2 initiation due to the current COVID-19 environment, we have reduced our operational expenditures and now have an additional six months of cash runway estimated to extend through mid-2022.\"\nProduct Development Update\nPTG-300: Injectable Hepcidin Mimetic \nInitial Phase 2 results in patients with polycythemia vera from an ongoing study demonstrated that treatment with PTG-300 at individualized doses ranging from 10 mg to 80 mg for up to 28 weeks controlled hematocrit levels. All patients were phlebotomy free (except a single phlebotomy due to an unintended dose interruption in a patient who remains on study). Administration of PTG-300 was well tolerated and the safety profile was generally similar with results of prior studies, with injection site reactions and bruise as the only adverse events related to or possibly related to treatment. Results are available as of the May 1, 2020, cutoff date. The results of the PTG-300 beta-thalassemia Phase 2 study will be presented a...