NEWARK, Calif., Oct. 21, 2020 /PRNewswire/ — Protagonist Therapeutics, Inc. (NASDAQ:PTGX) today declared that the European Medications Company (EMA) has granted orphan drug designation for PTG-300 in the remedy of polycythemia vera. PTG-300 is an injectable artificial peptide mimetic of the natural hormone hepcidin and has formerly obtained orphan drug designation for the treatment method of polycythemia vera from the U.S. Food and Drug Administration (Fda).
“This designation reflects the potential of PTG-300 as a treatment applicant and the world wide have to have for novel treatments for men and women living with polycythemia vera,” commented Samuel Saks, M.D., Protagonist Main Health-related Officer. “Early scientific benefits that were being reported in Could, as well as the novel non-cytoreductive therapeutic system of PTG-300 in regulating iron, propose that PTG-300 might aid a wide inhabitants of polycythemia vera individuals. We are at present engaged in conversations with leaders in therapy of polycythemia vera to style and design a pivotal examine. Completion of enrollment for the ongoing examine of 50 individuals is anticipated in mid-2021. A pivotal examine is expected to start off in the 2nd 50 percent of 2021, pending our planned conversations with regulatory organizations.”
A Section 2 examine of PTG-300 in individuals with polycythemia vera is at the moment enrolling topics. Added info is obtainable at http://ptg300pvstudy.com/.
About Polycythemia Vera
Polycythemia vera is a myeloproliferative neoplasm characterised principally by the greater output of crimson blood cells. Very well-established remedy tips focus on protecting hematocrit ranges repeatedly below 45 % to lower the chance of thrombotic activities. Regretably, present-day treatment method solutions are unable to preserve hematocrit to down below the 45 p.c goal for many sufferers and may well be involved with really serious side consequences. There are an believed 100,000 individuals with polycythemia vera in the U.S. and around 100,000 clients in main EU nations around the world.
About the European Medicines Company (EMA) Orphan Drug Designation
Orphan drug designation in the European Union (EU) is granted by the European Fee centered on a favourable impression issued by the EMA Committee for Orphan Medicinal Products and solutions. To qualify, a therapeutic candidate need to be supposed to treat a critical problem that affects much less than five in 10,000 people today in the EU, and there have to be sufficient information to advise the applicant could deliver clinically suitable results. The designation gives businesses with specific rewards and incentives for medical advancement and a period of time of current market exclusivity, if accepted.
About Protagonist Therapeutics, Inc.
Protagonist Therapeutics is a clinical phase biopharmaceutical corporation that utilizes a proprietary technological know-how platform to discover and acquire novel peptide-based mostly therapeutics to address important unmet healthcare wants and transform current remedy paradigms for sufferers. The Business at present has a few medical-stage assets. PTG-300 is an injectable hepcidin mimetic in improvement for the procedure of polycythemia vera and other blood disorders. PTG-200 is an orally sent, gut-limited, interleukin-23 receptor certain antagonist peptide in development for the treatment of inflammatory bowel illness, with Crohn’s disease as the preliminary indication. The Company has a around the world license and collaboration agreement with Janssen Biotech, Inc., for the progress of PTG-200. PN-943 is an orally delivered, intestine-limited alpha-4-beta-7 integrin specific antagonist peptide in progress for the cure of inflammatory bowel disease, with ulcerative colitis as the initial specific indication.
Protagonist is headquartered in Newark, California. For more facts, you should take a look at http://www.protagonist-inc.com.
Cautionary Observe on Forward-Hunting Statements
This push release has forward-looking statements for purposes of the secure harbor provisions of the Private Securities Litigation Reform Act of 1995. Ahead-on the lookout statements include things like statements about our intentions or current expectations relating to, among the other items, the opportunity positive aspects of PTG-300 in treating polycythemia vera, the timing of enrollment in our ongoing PTG-300 clinical trial and the graduation of a pivotal analyze of PTG-300 in polycythemia vera individuals. In some circumstances, you can identify these statements by forward-searching terms these kinds of as “foresee,” “consider,” “might,” “will,” “expect,” or the unfavorable or plural of these words or identical expressions. Ahead-wanting statements are not assures of long term performance and are subject to hazards and uncertainties that could result in true results and situations to vary materially from these expected, including, but not minimal to, our capacity to establish and commercialize our solution candidates, the effects of the present COVID-19 pandemic on our discovery and development attempts, our capability to use and broaden our courses to create a pipeline of item candidates, our skill to get hold of and retain regulatory acceptance of our merchandise candidates, our capability to work in a aggressive business and compete efficiently towards opponents that have increased resources than we do, and our capacity to get and sufficiently secure mental house legal rights for our solution candidates. Supplemental information and facts relating to these and other possibility variables impacting our business can be uncovered in our periodic filings with the Securities and Exchange Commission, like below the heading “Threat Components” contained in our Quarterly Report on Type 10-Q for the quarter ended June 30, 2020, filed with the Securities and Exchange Fee. Forward-searching statements are not ensures of upcoming functionality, and our true results of operations, economical situation and liquidity, and the development of the industry in which we function, may vary materially from the ahead-looking statements contained in this press launch. Any forward-seeking statements that we make in this push release talk only as of the day of this push release. We suppose no obligation to update our forward-wanting statements, whether as a end result of new info, future situations or normally, immediately after the day of this push launch.
Resource Protagonist Therapeutics, Inc.