Alterity Therapeutics Completes Last Patient Visit in ATH434-202 Open-Label Phase 2 Trial in Multiple System Atrophy
Alterity Therapeutics (NASDAQ: ATHE) has announced the completion of the last patient visit in its ATH434-202 Phase 2 open-label trial for Multiple System Atrophy (MSA). The study aims to evaluate the safety, efficacy, and target engagement of ATH434, a disease-modifying drug candidate for neurodegenerative diseases, specifically in patients with advanced MSA.
Following positive results from their previous randomized, double-blind Phase 2 trial, this open-label study focuses on a population with advanced-stage illness. The company expects to report topline data by mid-year 2025. CEO David Stamler emphasized that the data will help guide their development program, noting the differences between this study and the double-blind trial.
Alterity Therapeutics (NASDAQ: ATHE) ha annunciato il completamento dell'ultima visita del paziente nel suo studio clinico di fase 2, open-label, ATH434-202 per l'atrofia muscolare multipla (MSA). Lo studio mira a valutare la sicurezza, l'efficacia e l'impegno del bersaglio di ATH434, un candidato farmaco modificante la malattia per le malattie neurodegenerative, specificamente in pazienti con MSA avanzata.
Dopo i risultati positivi del loro precedente studio clinico randomizzato, in doppio cieco, di fase 2, questo studio open-label si concentra su una popolazione con malattia in fase avanzata. L'azienda prevede di riportare i dati preliminari entro metà anno 2025. Il CEO David Stamler ha sottolineato che i dati aiuteranno a guidare il loro programma di sviluppo, notando le differenze tra questo studio e quello in doppio cieco.
Alterity Therapeutics (NASDAQ: ATHE) ha anunciado la finalización de la última visita de paciente en su ensayo clínico de fase 2, abierto, ATH434-202 para la atrofia multisistémica (MSA). El estudio tiene como objetivo evaluar la seguridad, la eficacia y el compromiso del objetivo de ATH434, un candidato a fármaco modificador de la enfermedad para enfermedades neurodegenerativas, específicamente en pacientes con MSA avanzada.
Tras los resultados positivos de su anterior ensayo clínico aleatorizado, doble ciego, de fase 2, este estudio abierto se centra en una población con enfermedad en etapa avanzada. La compañía espera informar los datos preliminares para mediados de 2025. El CEO David Stamler enfatizó que los datos ayudarán a guiar su programa de desarrollo, señalando las diferencias entre este estudio y el ensayo doble ciego.
Alterity Therapeutics (NASDAQ: ATHE)는 다계통 위축증(MSA)에 대한 ATH434-202 2상 오픈 라벨 시험에서 마지막 환자 방문이 완료되었음을 발표했습니다. 이 연구는 신경퇴행성 질환에 대한 질병 수정 약물 후보인 ATH434의 안전성, 효능 및 표적 참여를 평가하는 것을 목표로 하고 있으며, 특히 진행된 MSA 환자들을 대상으로 합니다.
이전의 무작위 이중 맹검 2상 시험에서 긍정적인 결과를 바탕으로, 이번 오픈 라벨 연구는 진행된 질병 단계에 있는 인구에 초점을 맞추고 있습니다. 회사는 2025년 중반까지 주요 데이터를 보고할 것으로 예상하고 있습니다. CEO David Stamler는 데이터가 개발 프로그램을 안내하는 데 도움이 될 것이라고 강조하며, 이 연구와 이중 맹검 시험 간의 차이점을 언급했습니다.
Alterity Therapeutics (NASDAQ: ATHE) a annoncé l'achèvement de la dernière visite de patient dans son essai ouvert de phase 2 ATH434-202 pour l'atrophie multisystémique (MSA). L'étude vise à évaluer la sécurité, l'efficacité et l'engagement cible d'ATH434, un candidat médicament modifiant la maladie pour les maladies neurodégénératives, spécifiquement chez les patients atteints de MSA avancée.
Suite à des résultats positifs de leur précédent essai randomisé en double aveugle de phase 2, cette étude ouverte se concentre sur une population souffrant de la maladie à un stade avancé. L'entreprise s'attend à publier des données préliminaires d'ici le milieu de l'année 2025. Le PDG David Stamler a souligné que les données aideront à orienter leur programme de développement, en notant les différences entre cette étude et l'essai en double aveugle.
Alterity Therapeutics (NASDAQ: ATHE) hat den Abschluss des letzten Patientenbesuchs in seiner offenen Phase-2-Studie ATH434-202 zur multiplen Systematrophie (MSA) bekannt gegeben. Die Studie zielt darauf ab, die Sicherheit, Wirksamkeit und Zielverpflichtung von ATH434, einem krankheitsmodifizierenden Arzneimittelkandidaten für neurodegenerative Erkrankungen, insbesondere bei Patienten mit fortgeschrittener MSA, zu bewerten.
Nach positiven Ergebnissen aus ihrer vorherigen randomisierten, doppelblinden Phase-2-Studie konzentriert sich diese offene Studie auf eine Bevölkerung mit fortgeschrittener Erkrankung. Das Unternehmen erwartet, bis Mitte 2025 erste Ergebnisse zu berichten. CEO David Stamler betonte, dass die Daten helfen werden, ihr Entwicklungsprogramm zu leiten, und wies auf die Unterschiede zwischen dieser Studie und der doppelblinden Studie hin.
- Successful completion of patient visits in ATH434-202 Phase 2 trial
- Previous Phase 2 trial showed positive results
- Development progress for disease-modifying treatment in neurodegenerative diseases
- Results not expected until mid-2025
– ATH434 is a Disease Modifying Drug Candidate Targeting Parkinsonian Disorders –
– Topline Data Expected Mid-Year 2025 –
MELBOURNE, Australia and SAN FRANCISCO, March 27, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that the last patient in the ATH434-202 Phase 2 trial has completed the study. The ATH434-202 is an open label study designed to evaluate the safety, efficacy and target engagement of ATH434 in participants with advanced multiple system atrophy (MSA).
“Following the positive results from our randomized, double-blind Phase 2 trial1, we are pleased to announce that the last participant has now completed all clinical evaluations in our open-label study of advanced MSA,” said David Stamler, M.D., Chief Executive Officer of Alterity. “The 202 study gives us the opportunity to evaluate the effects of ATH434 treatment in a population that faces severe challenges due to the stage of their illness. The data from this study will help guide our development program given the differences between the 202 study and the double-blind trial. I greatly appreciate the contributions of the trial participants and thank them for their participation. We look forward to reporting topline data from this study in mid-year 2025.”
About ATH434-202 Phase 2 Clinical Trial
The ATH434-202 Phase 2 clinical trial is an open label study, entitled “A Biomarker Study of ATH434 in Participants with MSA.” The Biomarker trial enrolled 10 individuals with advanced MSA. ATH434-202 study participants received treatment with ATH434 at the 75 mg dose for 12-months. The study will assess the effect of ATH434 treatment on neuroimaging and protein biomarkers to evaluate target engagement, in addition to clinical measures, safety, and pharmacokinetics. The selected biomarkers, including brain volume, iron and aggregating α-synuclein, are important contributors to MSA pathology and are appropriate targets to demonstrate drug activity. The primary objective of this study is to evaluate the impact of 12 months treatment with ATH434 on brain volume in a more advanced patient population than was studied in Alterity’s randomized Phase 2 trial. Additional information on the open label Phase 2 trial can be found at clinicaltrials.gov NCT05864365.
About ATH434
Alterity’s 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 α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain. As an iron chaperone, it has excellent potential to treat Parkinson’s 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 recently announced positive results from the randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with early-stage MSA. A second Phase 2 open-label 2 Biomarker trial in patients with more advanced MSA is ongoing. ATH434 has been granted Orphan Drug Designation for the treatment of MSA by the U.S. FDA and the European Commission.
About Multiple System Atrophy
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 α-synuclein within glia, the support cells of the central nervous system, and neuron loss in multiple brain regions. MSA affects at least 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
1Multiple System Atrophy | National Institute of Neurological Disorders and Stroke (nih.gov)
About Alterity Therapeutics Limited
Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company is initially focused on developing disease modifying therapies in Parkinson’s disease and related disorders. Alterity recently reported positive data for its lead asset, ATH434, in a Phase 2 clinical trial in participants with Multiple System Atrophy (MSA), a rare and rapidly progressive Parkinsonian disorder. ATH434 is also being evaluated in a Phase 2 clinical trial in advanced MSA. In addition, Alterity has a broad drug discovery platform generating patentable chemical compounds to treat the underlying pathology of neurological diseases. The Company is based in Melbourne, Australia, and San Francisco, California, USA. For further information please visit the Company’s website at www.alteritytherapeutics.com.
Sources:
1ATH434-201 Phase 2 trial results release
Authorisation & Additional information
This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited.
Investor and Media Contacts:
Australia
Ana Luiza Harrop
we-aualteritytherapeutics@we-worldwide.com
+61 452 510 255
U.S.
Remy Bernarda
remy.bernarda@iradvisory.com
+1 (415) 203-6386
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by 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 statements.
Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled “Risk Factors” in the Company’s filings with the SEC, including its most recent Annual Report on Form 20-F as well as reports on Form 6-K, including, but not limited to the following: statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but not limited to, ATH434, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to, ATH434, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, ATH434, that could slow or prevent products coming to market, the uncertainty of obtaining patent protection for the Company's intellectual property or trade secrets, the uncertainty of successfully enforcing the Company’s patent rights and the uncertainty of the Company freedom to operate.
Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
FAQ
When will Alterity Therapeutics (ATHE) release topline data for the ATH434-202 Phase 2 trial?
What is the purpose of ATHE's ATH434-202 Phase 2 trial in Multiple System Atrophy?
How does the ATH434-202 trial differ from ATHE's previous Phase 2 trial?
What type of drug is ATH434 being developed as by ATHE?
