{"id":740616,"date":"2023-03-16T07:28:01","date_gmt":"2023-03-16T11:28:01","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/alterity-therapeutics-enrolls-first-patient-in-the-u-s-in-ath434-phase-2-clinical-trial-in-multiple-system-atrophy\/"},"modified":"2023-03-16T07:28:01","modified_gmt":"2023-03-16T11:28:01","slug":"alterity-therapeutics-enrolls-first-patient-in-the-u-s-in-ath434-phase-2-clinical-trial-in-multiple-system-atrophy","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/alterity-therapeutics-enrolls-first-patient-in-the-u-s-in-ath434-phase-2-clinical-trial-in-multiple-system-atrophy\/","title":{"rendered":"Alterity Therapeutics Enrolls First Patient in the U.S. in ATH434 Phase 2 Clinical Trial in Multiple System Atrophy"},"content":{"rendered":"
\n

MELBOURNE, Australia and\u00a0SAN FRANCISCO, March 16, 2023 (GLOBE NEWSWIRE) — Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (\u201cAlterity\u201d or \u201cthe Company\u201d), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the first participant has been dosed in the U.S. in the Company\u2019s Phase 2 clinical trial of ATH434 in Multiple System Atrophy (MSA), a rare and highly debilitating Parkinsonian disorder.<\/p>\n

\u201cThe U.S. is an important region for our ATH434 Phase 2 clinical trial, and we are thrilled to have dosed our first patient at Vanderbilt University Medical Center,\u201d said David Stamler, M.D., Chief Executive Officer, Alterity. \u201cOur colleagues at Vanderbilt are long-time supporters of the ATH434 development program and we are grateful for their continued efforts. The Phase 2 trial is gaining momentum with active recruitment in five countries, as we look to bring a potential new treatment option to individuals living with MSA.\u201d<\/p>\n

The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will evaluate the effect of ATH434 treatment on neuroimaging and protein biomarkers to demonstrate target engagement, and clinical endpoints to demonstrate efficacy, in addition to assessments of safety and pharmacokinetics. The selected biomarkers, including brain iron and aggregating \u03b1-synuclein, are important contributors to MSA pathology and are therefore appropriate targets to demonstrate drug activity. Wearable sensors will also be employed to evaluate motor activities that are important to patients with MSA. The study is expected to enroll approximately 60 adults to receive one of two dose levels of ATH434 or placebo. Participants will receive treatment for 12 months which will provide an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study. Additional information on the Phase 2 trial can be found by ClinicalTrials.gov Identifier: NCT05109091<\/a>.<\/p>\n

\n About ATH434<\/strong>\n <\/p>\n

Alterity\u2019s lead candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce \u03b1-synuclein pathology and preserve nerve cells by restoring normal iron balance in the brain. As an iron chaperone, it has excellent potential to treat Parkinson\u2019s disease as well as various Parkinsonian disorders such as Multiple System Atrophy (MSA). ATH434 successfully completed Phase 1 studies demonstrating the agent is well tolerated and achieved brain levels comparable to efficacious levels in animal models of MSA. ATH434 is currently being studied in a randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with early-stage MSA. ATH434 has been granted Orphan designation for the treatment of MSA by the U.S. FDA and the European Commission.<\/p>\n

\n About Multiple System Atrophy<\/strong>\n <\/p>\n

Multiple System Atrophy (MSA) is a rare, neurodegenerative disease characterized by failure of the autonomic nervous system and impaired movement. The symptoms reflect the progressive loss of function and death of different types of nerve cells in the brain and spinal cord. It is a rapidly progressive disease and causes profound disability. MSA is a Parkinsonian disorder characterized by a variable combination of slowed movement and\/or rigidity, autonomic instability that affects involuntary functions such as blood pressure maintenance and bladder control, and impaired balance and\/or coordination that predisposes to falls. A pathological hallmark of MSA is the accumulation of the protein \u03b1-synuclein within glia, the support cells of the central nervous system, and neuron loss in multiple brain regions. MSA affects approximately 15,000 individuals in the U.S., and while some of the symptoms of MSA can be treated with medications, currently there are no drugs that are able to slow disease progression and there is no cure.1<\/sup><\/p>\n

\n 1<\/sup>
\n Multiple System Atrophy | National Institute of Neurological Disorders and Stroke (nih.gov)<\/a>\n <\/p>\n

\n About Alterity Therapeutics Limited <\/strong>\n <\/p>\n

Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living\u00a0with neurodegenerative diseases. The Company\u2019s lead asset, ATH434, has the potential to treat various Parkinsonian disorders. Alterity also has a broad drug discovery platform generating patentable chemical compounds to intercede in disease processes. The Company is based in Melbourne, Australia, and San Francisco, California, USA. For further information please visit the Company\u2019s web site at www.alteritytherapeutics.com.<\/a><\/p>\n

\n
\n Authorisation & Additional information<\/strong>
\n
This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited.<\/p>\n

\n Investor and Media Contacts:<\/strong>\n <\/p>\n

\n Australia<\/strong>
\n
Ana Luiza Harrop
we-aualteritytherapeutics@we-worldwide.com<\/a>
+61 452 510 255<\/p>\n

\n U.S.<\/strong>
\n
Remy Bernarda
remy.bernarda@iradvisory.com<\/a>
+1 (415) 203-6386<\/p>\n

\n Forward Looking Statements<\/strong>\n <\/p>\n

\n This press release contains “forward-looking statements” within the meaning of section 27A of the Securities Act of 1933 and section<\/em>
\n 21E<\/em>
\n of<\/em>
\n the<\/em>
\n Securities<\/em>
\n Exchange<\/em>
\n Act<\/em>
\n of<\/em>
\n 1934.<\/em>
\n The<\/em>
\n Company<\/em>
\n has<\/em>
\n tried<\/em>
\n to<\/em>
\n identify<\/em>
\n such<\/em>
\n forward-looking<\/em>
\n statements<\/em>
\n by<\/em>
\n use of such words as “expects,” “intends,” “hopes,” “anticipates,” “believes,” “could,” “may,” “evidences” and “estimates,” and other similar expressions, but these words are not the exclusive means of identifying such<\/em>
\n statements.<\/em>\n <\/p>\n

\n Important<\/em>
\n factors<\/em>
\n that<\/em>
\n could<\/em>
\n cause<\/em>
\n actual<\/em>
\n results<\/em>
\n to<\/em>
\n differ<\/em>
\n materially<\/em>
\n from<\/em>
\n those<\/em>
\n indicated<\/em>
\n by<\/em>
\n such<\/em>
\n forward-looking<\/em>
\n statements are<\/em>
\n described<\/em>
\n in<\/em>
\n the<\/em>
\n sections<\/em>
\n titled<\/em>
\n \u201cRisk<\/em>
\n Factors\u201d<\/em>
\n in<\/em>
\n the<\/em>
\n Company\u2019s<\/em>
\n filings<\/em>
\n with<\/em>
\n the<\/em>
\n SEC,<\/em>
\n including<\/em>
\n its<\/em>
\n most<\/em>
\n recent<\/em>
\n Annual<\/em>
\n Report on<\/em>
\n Form<\/em>
\n 20-F<\/em>
\n as<\/em>
\n well<\/em>
\n as<\/em>
\n reports<\/em>
\n on<\/em>
\n Form<\/em>
\n 6-K,<\/em>
\n including,<\/em>
\n but<\/em>
\n not<\/em>
\n limited<\/em>
\n to<\/em>
\n the<\/em>
\n following:<\/em>
\n statements<\/em>
\n relating<\/em>
\n to<\/em>
\n the<\/em>
\n Company’s drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company’s<\/em>
\n drug<\/em>
\n development<\/em>
\n program,<\/em>
\n including,<\/em>
\n but<\/em>
\n not<\/em>
\n limited<\/em>
\n to,<\/em>
\n ATH434,<\/em>
\n and<\/em>
\n any<\/em>
\n other<\/em>
\n statements<\/em>
\n that<\/em>
\n are<\/em>
\n not<\/em>
\n historical facts.<\/em>
\n Such<\/em>
\n statements<\/em>
\n involve<\/em>
\n risks<\/em>
\n and<\/em>
\n uncertainties,<\/em>
\n including,<\/em>
\n but<\/em>
\n not<\/em>
\n limited<\/em>
\n to,<\/em>
\n those<\/em>
\n risks<\/em>
\n and<\/em>
\n uncertainties<\/em>
\n relating<\/em>
\n to<\/em>
\n the difficulties<\/em>
\n or<\/em>
\n delays<\/em>
\n in<\/em>
\n financing,<\/em>
\n development,<\/em>
\n testing,<\/em>
\n regulatory<\/em>
\n approval,<\/em>
\n production<\/em>
\n and<\/em>
\n marketing<\/em>
\n of<\/em>
\n the<\/em>
\n Company\u2019s<\/em>
\n drug components,<\/em>
\n including,<\/em>
\n but<\/em>
\n not<\/em>
\n limited<\/em>
\n to,<\/em>
\n ATH434,<\/em>
\n uncertainties relating to the impact of the novel coronavirus (COVID-19)<\/em>
\n pandemic<\/em>
\n on<\/em>
\n the<\/em>
\n company\u2019s<\/em>
\n business,<\/em>
\n operations<\/em>
\n and<\/em>
\n employees, the<\/em>
\n ability<\/em>
\n of<\/em>
\n the<\/em>
\n Company<\/em>
\n to<\/em>
\n procure<\/em>
\n additional<\/em>
\n future<\/em>
\n sources<\/em>
\n of<\/em>
\n financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug compounds, including, but not limited<\/em>
\n to,<\/em>
\n ATH434,<\/em>
\n that<\/em>
\n could<\/em>
\n slow<\/em>
\n or prevent products<\/em>
\n coming<\/em>
\n to<\/em>
\n market,<\/em>
\n the uncertainty<\/em>
\n of obtaining patent protection<\/em>
\n for<\/em>
\n the<\/em>
\n Company’s intellectual<\/em>
\n property<\/em>
\n or<\/em>
\n trade<\/em>
\n secrets, the uncertainty of successfully enforcing the Company\u2019s patent rights and the uncertainty of the Company freedom to operate.<\/em>\n <\/p>\n

\n Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks<\/em>
\n only<\/em>
\n as<\/em>
\n of<\/em>
\n the<\/em>
\n date<\/em>
\n on<\/em>
\n which<\/em>
\n it<\/em>
\n is<\/em>
\n made.<\/em>
\n We<\/em>
\n undertake<\/em>
\n no<\/em>
\n obligation<\/em>
\n to<\/em>
\n publicly<\/em>
\n update<\/em>
\n any<\/em>
\n forward-looking<\/em>
\n statement, whether<\/em>
\n written<\/em>
\n or<\/em>
\n oral,<\/em>
\n that<\/em>
\n may<\/em>
\n be<\/em>
\n made<\/em>
\n from<\/em>
\n time<\/em>
\n to<\/em>
\n time,<\/em>
\n whether<\/em>
\n as<\/em>
\n a<\/em>
\n result<\/em>
\n of<\/em>
\n new<\/em>
\n information,<\/em>
\n future<\/em>
\n developments<\/em>
\n or otherwise.<\/em>\n <\/p>\n<\/p>\n


\n
\n \n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

MELBOURNE, Australia and\u00a0SAN FRANCISCO, March 16, 2023 (GLOBE NEWSWIRE) — Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (\u201cAlterity\u201d or \u201cthe Company\u201d), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the first participant has been dosed in the U.S. in the Company\u2019s Phase 2 clinical trial of ATH434 in Multiple System Atrophy (MSA), a rare and highly debilitating Parkinsonian disorder. \u201cThe U.S. is an important region for our ATH434 Phase 2 clinical trial, and we are thrilled to have dosed our first patient at Vanderbilt University Medical Center,\u201d said David Stamler, M.D., Chief Executive Officer, Alterity. \u201cOur colleagues at Vanderbilt are long-time supporters of the ATH434 development program and we are grateful for their continued efforts. … <\/p>\n

Continue reading “Alterity Therapeutics Enrolls First Patient in the U.S. in ATH434 Phase 2 Clinical Trial in Multiple System Atrophy”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-740616","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nAlterity Therapeutics Enrolls First Patient in the U.S. in ATH434 Phase 2 Clinical Trial in Multiple System Atrophy - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/alterity-therapeutics-enrolls-first-patient-in-the-u-s-in-ath434-phase-2-clinical-trial-in-multiple-system-atrophy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Alterity Therapeutics Enrolls First Patient in the U.S. in ATH434 Phase 2 Clinical Trial in Multiple System Atrophy - 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