NEWARK - Protagonist Therapeutics, Inc. (Nasdaq: PTGX) today announced the results of a large-scale analysis of real world treatment patterns for polycythemia vera, demonstrating that treatment incorporating existing options failed to achieve hematocrit control for a majority of patients and across broad categories of patient groups over the course of two years of observations.
The analysis included patients in both high risk and low risk groups, as well as patients receiving phlebotomy alone or phlebotomy as a component of combination treatment. Details will be presented today at the American Society for Hematology (ASH) 2020 annual meeting.
'This analysis shows that patients with polycythemia vera are often not receiving appropriate treatment, thereby potentially exposing these patients to life-threatening risks such as the risk of experiencing thrombotic events,' commented Srdan Verstovsek, M.D, Ph.D., research co-author and Director of the Clinical Research Center for Myeloproliferative Neoplasms at the MD Anderson Cancer Center. 'Improving treatment patterns would likely help avoid risks, improve quality of life, and potentially avoid unnecessarily utilization of health care resources associated with adverse outcomes.'
The large scale analysis with 4,264 patients analyzed indicated that only 22 percent of a representative population of patients had hematocrit values maintained below the NCCN recommended guideline level of 45 percent. A majority of patients in the high risk population received treatment with phlebotomy alone, and hematocrit levels were often above recommended levels, and nearly half (49 percent) of patients had hematocrit levels substantially above recommended levels (above 50 percent) at least once during the observation period. Consistent with inadequate hematocrit control, a high incidence of thrombotic events was observed in patients receiving treatment.
'Our interpretation of these results is that there is a significant unmet need for effective treatment options for patients with polycythemia vera,' commented Samuel Saks, M.D., Protagonist Chief Medical Officer. 'Patients are being poorly treated, resulting in excessive risk.'
About Polycythemia Vera
Polycythemia vera is a myeloproliferative neoplasm characterized primarily by the increased production of red blood cells. Well-established treatment guidelines focus on maintaining hematocrit levels continuously below 45 percent to reduce the risk of thrombotic events. Unfortunately, current treatment options are unable to maintain hematocrit to below the 45 percent target for many patients and may be associated with serious side effects. There are an estimated 100,000 patients with polycythemia vera in the U.S. and approximately 100,000 patients in major EU countries.
About Protagonist Therapeutics, Inc.
Protagonist Therapeutics is a clinical stage biopharmaceutical company that utilizes a proprietary technology platform to discover and develop novel peptide-based therapeutics to address significant unmet medical needs and transform existing treatment paradigms for patients. PTG-300 is an injectable hepcidin mimetic in development for the treatment of polycythemia vera and other blood disorders. PTG-200 is an orally delivered, gut-restricted, interleukin-23 receptor specific antagonist peptide in development for the treatment of inflammatory bowel disease, with Crohn's disease as the initial indication. In addition to PTG-200, two oral peptide interleukin-23 receptor antagonist candidates from a collaboration with Janssen Biotech, Inc., are in development and have been selected for advancement into clinical studies. PN-943 is an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide in development for the treatment of inflammatory bowel disease, with ulcerative colitis as the initial targeted indication.
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