A phase 1, single-center, randomized, open-label, 3-way crossover study to evaluate the systemic exposure after administration of a tablet formulation of PBT434 in the fed and fasted states compared to a powder in capsule formulation in healthy volunteers

开始日期2020-11-02

申办/合作机构

Alterity Therapeutics Ltd.

100 项与 PBT-434 相关的临床结果

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100 项与 PBT-434 相关的转化医学

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100 项与 PBT-434 相关的专利（医药）

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项与 PBT-434 相关的文献（医药）

2024-10-04·Metallomics

ATH434, a promising iron-targeting compound for treating iron regulation disorders

Article

作者: Stoj, Christopher S ; Stemmler, Timothy L ; Parsons, Jack ; Kosman, Daniel J ; Bailey, Danielle K ; Bond, Silas ; Huggins, Penny ; Pall, Ashley E ; Bradbury, Margaret J ; Deschamps, Isabel

Abstract:

Cytotoxic accumulation of loosely bound mitochondrial Fe2+ is a hallmark of Friedreich's Ataxia (FA), a rare and fatal neuromuscular disorder with limited therapeutic options. There are no clinically approved medications targeting excess Fe2+ associated with FA or the neurological disorders Parkinson's disease and Multiple System Atrophy. Traditional iron-chelating drugs clinically approved for systemic iron overload that target ferritin-stored Fe3+ for urinary excretion demonstrated limited efficacy in FA and exacerbated ataxia. Poor treatment outcomes reflect inadequate binding to excess toxic Fe2+ or exceptionally high affinities (i.e. ≤10−31) for non-pathologic Fe3+ that disrupts intrinsic iron homeostasis. To understand previous treatment failures and identify beneficial factors for Fe2+-targeted therapeutics, we compared traditional Fe3+ chelators deferiprone (DFP) and deferasirox (DFX) with additional iron-binding compounds including ATH434, DMOG, and IOX3. ATH434 and DFX had moderate Fe2+ binding affinities (Kd’s of 1–4 µM), similar to endogenous iron chaperones, while the remaining had weaker divalent metal interactions. These compounds had low/moderate affinities for Fe3+(0.46–9.59 µM) relative to DFX and DFP. While all compounds coordinated iron using molecular oxygen and/or nitrogen ligands, thermodynamic analyses suggest ATH434 completes Fe2+ coordination using H2O. ATH434 significantly stabilized bound Fe2+ from ligand-induced autooxidation, reducing reactive oxygen species (ROS) production, whereas DFP and DFX promoted production. The comparable affinity of ATH434 for Fe2+ and Fe3+ position it to sequester excess Fe2+ and facilitate drug-to-protein iron metal exchange, mimicking natural endogenous iron binding proteins, at a reduced risk of autooxidation-induced ROS generation or perturbation of cellular iron stores.

2022-10-01·Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics

ATH434 Rescues Pre-motor Hyposmia in a Mouse Model of Parkinsonism

Article

作者: Beauchamp, Leah C ; Bush, Ashley I ; Vella, Laura J ; Barnham, Kevin J ; Adlard, Paul A ; Liu, Xiang M ; Finkelstein, David I

Hyposmia is a prevalent prodromal feature of Parkinson's disease (PD), though the neuropathology that underlies this symptom is poorly understood. Unlike the substantia nigra, the status of metal homeostasis in the olfactory bulbs has not been characterized in PD. Given the increasing interest in metal modulation as a therapeutic avenue in PD, we sought to investigate bulbar metals and the effect of AT434 (formerly PBT434) an orally bioavailable, small molecule modulator of metal homeostasis on hyposmia in a mouse model of parkinsonism (the tau knockout (tau^-/-) mouse). 5.5 (pre-hyposmia) and 13.5-month-old (pre-motor) mice were dosed with ATH434 (30 mg/kg/day, oral gavage) for 6 weeks. Animals then underwent behavioral analysis for olfactory and motor phenotypes. The olfactory bulbs and the substantia nigra were then collected and analyzed for metal content, synaptic markers, and dopaminergic cell number. ATH434 was able to prevent the development of hyposmia in young tau^-/- mice, which coincided with a reduction in bulbar iron and copper levels, an increase in synaptophysin, and a reduction in soluble α-synuclein. ATH434 was able to prevent the development of motor impairment in aged tau^-/- mice, which coincided with a reduction in iron levels and reduced neurodegeneration in the substantia nigra. These data implicate metal dyshomeostasis in parkinsonian olfactory deficits, and champion a potential clinical benefit of ATH434 in both prodromal and clinical stages of PD.

2022-01-21·Journal of Parkinson's disease3区 · 医学

The Compound ATH434 Prevents Alpha-Synuclein Toxicity in a Murine Model of Multiple System Atrophy

3区 · 医学

Article

作者: Barnham, Kevin J. ; Saleh, Eiman ; Adlard, Paul A. ; Cherny, Robert A. ; Billings, Jessica L. ; Stefanova, Nadia ; Shukla, Jay J. ; Finkelstein, David I.

Background: An elevation in iron levels, together with an accumulation of α-synuclein within the oligodendrocytes, are features of the rare atypical parkinsonian disorder, Multiple System Atrophy (MSA). We have previously tested the novel compound ATH434 (formally called PBT434) in preclinical models of Parkinson’s disease and shown that it is brain-penetrant, reduces iron accumulation and iron-mediated redox activity, provides neuroprotection, inhibits alpha synuclein aggregation and lowers the tissue levels of alpha synuclein. The compound was also well-tolerated in a first-in-human oral dosing study in healthy and older volunteers with a favorable, dose-dependent pharmacokinetic profile. Objective: To evaluate the efficacy of ATH434 in a mouse MSA model. Methods: The PLP-α-syn transgenic mouse overexpresses α-synuclein, demonstrates oligodendroglial pathology, and manifests motor and non-motor aspects of MSA. Animals were provided ATH434 (3, 10, or 30 mg/kg/day spiked into their food) or control food for 4 months starting at 12 months of age and were culled at 16 months. Western blot was used to assess oligomeric and urea soluble α-synuclein levels in brain homogenates, whilst stereology was used to quantitate the number of nigral neurons and glial cell inclusions (GCIs) present in the substantia nigra pars compacta. Results: ATH434 reduced oligomeric and urea soluble α-synuclein aggregation, reduced the number of GCIs, and preserved SNpc neurons. In vitro experiments suggest that ATH434 prevents the formation of toxic oligomeric “species of synuclein”. Conclusion: ATH434 is a promising small molecule drug candidate that has potential to move forward to trial for treating MSA.

项与 PBT-434 相关的新闻（医药）

2024-11-06

·GlobeNewswire-Health Care

Alterity Therapeutics Announces New Publication Describing Novel Mechanism of Action for ATH434

– Peer-Reviewed Publication Describes How ATH434 Uniquely Targets Excess Iron –MELBOURNE, AUSTRALIA and SAN FRANCISCO, Nov. 06, 2024 (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 peer-reviewed journal, Metallomics has published data on the importance of iron and iron-targeting agents like ATH434 to treat neurodegenerative diseases. Metallomics publishes cutting-edge investigations that elucidate the dynamics, role, and impact of metals in biological systems. David Stamler, M.D., Chief Executive Officer of Alterity, commented, “Iron has long been implicated in neurodegeneration, but having the appropriate iron-targeting agent is critical to having a positive impact on treating disease. This ground-breaking publication demonstrates the novel way in which ATH434 targets the labile, or reactive, form of iron which can be so damaging to cells when in excess. ATH434 acts as an iron chaperone to redistribute this excess reactive iron, thereby reducing protein aggregation and oxidative stress in the brain and rescuing neuronal function.” The publication, entitled, “ATH434, a promising iron-targeting compound for treating iron regulation disorders” was led by author Ashley Pall, Department of Pharmaceutical Sciences at Wayne State University. The novel iron binding properties of ATH434 presented in the publication support the characterization of ATH434 as an iron chaperone. The publication describes how ATH434 targets the toxic form of iron that drives the pathology of a rare neurodegenerative disease known as Friedreich’s Ataxia. This toxic form of iron is also involved in the pathogenesis of Parkinson’s disease and multiple system atrophy (MSA), which is the company’s lead indication. The study also evaluated iron chelators that are designed to irreversibly bind the stored form of iron and remove it from the body. Specifically, the study investigated how strongly ATH434 or iron chelators bind the two forms of cellular iron: ferric iron, the stored form, or ferrous iron, the active form required for vital cellular functions such as energy production but which is associated with toxicity when in excess. The new data confirmed that ATH434 has a dramatically lower affinity for ferric iron than iron chelators which are approved for treating systemic iron overload. ATH434’s binding is reversible and will not remove iron from the body. The study also confirmed an undesirable property of iron chelators: They promote conversion of ferrous to ferric iron, generating damaging free radicals in the process. In comparison, ATH434 was significantly less likely to drive this reaction. Together, these properties suggest that ATH434 has the capacity to selectively target the pathogenic form of iron without impairing normal cellular iron trafficking or functions. Access to the abstract and full publication are available here. 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 is currently being studied in two clinical trials: Study ATH434-201 is a randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with early-stage MSA and Study ATH434-202 is an open-label Phase 2 Biomarker trial in patients with more advanced MSA. ATH434 has been granted Orphan drug designation for the treatment of MSA by the U.S. FDA and the European Commission. 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’s lead asset, ATH434, has the potential to treat various Parkinsonian disorders and is currently being evaluated in two Phase 2 clinical trials in Multiple System Atrophy. Alterity also 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 web site at www.alteritytherapeutics.com. Authorisation & Additional informationThis announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Investor and Media Contacts: AustraliaAna Luiza Harropwe-aualteritytherapeutics@we-worldwide.com+61 452 510 255 U.S.Remy Bernardaremy.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.

临床1期临床结果临床2期孤儿药

2024-10-31

·GlobeNewswire-Health Care

Appendix 4C – Q1 FY25 Quarterly Cash Flow Report

Highlights Topline data for ATH434-201 randomized, double-blind Phase 2 clinical trial on track for release in January 2025Positive interim data reported from ATH434-202 Phase 2 clinical trial showing the potential for ATH434 to modify disease progression in Multiple System AtrophyMultiple data presentations at the International Congress of Parkinson’s Disease and Movement Disorders® (MDS)Appointed Abby Macnish Niven as Chief Financial OfficerCash balance on 30 September 2024 of A$9.28m MELBOURNE, Australia and SAN FRANCISCO, Oct. 31, 2024 (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 released its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 30 September 2024 (Q1 FY25). “We are excited about what this fiscal year has to offer as we started by reporting promising data from our Phase 2 clinical trial in participants with advanced multiple system atrophy (MSA),” said, David Stamler, M.D., Chief Executive Officer of Alterity. “The interim results from the ATH434-202 study suggest that ATH434 has potential to modify disease progression. Importantly, the stabilization of iron content in certain brain regions, combined with key biomarker data, indicates that ATH434 may slow neurodegeneration by modulating brain iron levels and reducing oxidative injury. These early data are an exciting indicator of what we might expect to see from our ATH434-201 trial in MSA patients with early-stage disease that is expected to read out in January 2025.” “Last month, we delivered multiple presentations at the International Congress of Parkinson’s Disease and Movement Disorders® (MDS), a prominent neurology meeting. At this event, we presented clinical and preclinical data demonstrating the potential of ATH434 in a variety of neurological conditions including early-stage MSA, advanced MSA, and Parkinson’s disease. We look forward to presenting additional data at medical meetings, and the topline results from both our ATH434-201 and ATH434-202 trials in calendar year 2025,” added, Dr. Stamler. Alterity’s cash position on 30 September 2024 was A$9.28 with operating cash outflows for the quarter of A$3.31M. In accordance with ASX Listing Rule 4.7C, payments of A$94k made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates directors’ fees, consulting fees, remuneration and superannuation at commercial rates. Operational Activities ATH434–202: Open-label, Biomarker Phase 2 Clinical Trial in Advanced MSA On 17 July 2024, Alterity reported positive interim data from the ATH434-202 trial in participants with advanced MSA. The data were also presented in September 2024 as both a late-breaking oral presentation and poster session by Daniel O. Claassen, M.D., M.S., Professor of Neurology, Vanderbilt University Medical Center at the International Congress of Parkinson’s Disease and Movement Disorders® (MDS). The early outcomes reported from the interim analysis suggest that ATH434 has potential to modify disease progression. The interim analysis included clinical and biomarker data on 7 participants treated with ATH434 for 6 months and neuroimaging data on 3 participants who were treated for 12 months. ATH434 was well tolerated with no drug-related serious adverse events, and most adverse events were mild to moderate, showing a favorable safety profile. The data suggest that ATH434 may have a disease-modifying effect in MSA, as 30% of participants had stable or improved clinical outcomes (clinical responders). The average change in Unified MSA Rating Scale Part I (UMSARS I) scores over 6 months was smaller than observed in a historical group of untreated MSA patients, suggesting reduced disability on activities of daily living. At 6 months all participants exhibited brain volume declines consistent with MSA progression; however, the clinical responders maintained stable brain volumes at 12 months. Importantly, the clinical responders on average showed stability in iron levels on MRI in the substantia nigra, putamen and globus pallidus, as well as stable levels of Neurofilament light chain (NfL), a marker of axonal injury, when compared to participants who declined. The stabilization of iron content in these subcortical brain regions, combined with NfL biomarker data, indicates that ATH434 may slow neurodegeneration by modulating brain iron levels and reducing oxidative injury. The trial remains ongoing with Topline 12-month results expected in the first half of calendar year 2025. ATH434–201: Randomized, Double-Blind Phase 2 Clinical Trial in Early-State MSA In September 2024, Dr. Stamler delivered an Oral Platform presentation and poster session at MDS, entitled, “A Phase 2 Study of ATH434, a Novel Inhibitor of α-Synuclein Aggregation, for the Treatment of Multiple System Atrophy”. The oral presentation and poster described the baseline characteristics for the 77 participants from Alterity’s ATH434-201 randomized, double-blind Phase 2 clinical trial, with a focus on baseline fluid biomarkers, neuroimaging and clinical data. The participants met strict selection criteria designed to confirm they had early-stage (clinically probable) MSA. The presentation further demonstrated that increased iron levels were evident in multiple subcortical brain regions, with increases being observed in the substantia nigra in nearly all subjects, and that ATH434 has potential to slow neurodegeneration based on its ability to redistribute this excess brain iron. Data were also presented indicating that plasma levels of neurofilament light chain, a marker of neuronal injury, were correlated with disease severity at baseline. The trial remains on track to complete in November 2024. The data from the trial will then be analyzed and the Company expects to report topline results in January 2025. bioMUSE Natural History Study The Company’s “Biomarkers of progression in Multiple System Atrophy” (bioMUSE) natural history study continues to produce promising data to track the progression of individuals with MSA and characterize MSA in terms of various biomarkers. At the MDS meeting in September 2024, a poster featuring bioMUSE data was presented entitled, “Association Between Clinical Progression in Multiple System Atrophy and Brain Volume Changes Evaluated via Deep Learning Segmentation”. The poster described the novel MRI imaging techniques and deep learning segmentation that were used to assess brain volume in MSA brain regions of interest (ROI) in bioMUSE participants. Structural MRI plays a critical role in both diagnosing MSA and monitoring disease progression. Subcortical brain volume shows potential as a biomarker for evaluating disease-modifying therapies. Over the course of one year, MRI with deep-learning segmentation revealed significant brain volume reduction in MSA ROIs whereas Parkinson’s disease patients showed no significant brain volume changes. In contrast, the MSA patients exhibited significant volume reductions in the cerebellum, globus pallidus, and brainstem. In addition, patients with the parkinsonian variant of MSA showed significant volume loss in the putamen. The results illustrate the correlation between the brain volume reduction and worsening clinical scores, as measured by the UMSARS, providing the basis for subcortical brain volume as a potential biomarker in treatment studies. ATH434 for the Treatment of Parkinson’s Disease In September 2024, a poster was presented at MDS entitled, “Effects of ATH434, a Clinical-Phase Small Molecule with Moderate Affinity for Iron, in Hemiparkinsonian Macaques”. The presentation demonstrated that ATH434 treatment led to lower iron levels in the affected area of the brain, the substantia nigra, and improved motor performance and general function in monkeys with experimentally induced Parkinson’s disease. At week 12, all 5 ATH434-treated macaques had stable or improving scores from Baseline while two of three vehicle-treated macaques did not demonstrate improvement. The improved general behavior was well-correlated with reduced motor impairment. These favorable parkinsonian outcomes observed in each of the ATH434-treated monkeys were also associated with increased levels of striatal synaptophysin, a protein marker that reflects functional connections between neurons, suggesting functional recovery of nerve endings in this critical motor pathway. These results support further investigation of ATH434 for the treatment of Parkinson’s disease. Corporate Activities On September 30, 2024, Alterity announced Abby Macnish Niven as the Company’s Chief Financial Officer. Ms Macnish Niven consults for a range of listed and unlisted companies in governance, finance and corporate structure. She holds Bachelor of Commerce and Bachelor of Science degrees from University of Western Australia and is a Chartered Finance Analyst. During the quarter, management participated in multiple investor activities including a webinar hosted by MST Financial, and a presentation hosted by ShareCafe. 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’s lead asset, ATH434, has the potential to treat various Parkinsonian disorders and is currently being evaluated in two Phase 2 clinical trials in Multiple System Atrophy. Alterity also 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 web site at www.alteritytherapeutics.com. Authorisation & Additional informationThis announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Investor and Media Contacts: AustraliaAna Luiza Harropwe-aualteritytherapeutics@we-worldwide.com+61 452 510 255 U.S.Remy Bernardaremy.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.

临床结果临床2期临床1期高管变更

2024-10-14

·GlobeNewswire-Health Care

Alterity Therapeutics to Participate in a Fireside Chat at the 2024 Maxim Healthcare Virtual Summit on 17 October 2024

MELBOURNE, Australia and SAN FRANCISCO, Oct. 14, 2024 (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 David Stamler, M.D., Chief Executive Officer of Alterity will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on Thursday, 17 October 2024 at 1:30 p.m. ET in the United States / Friday, 18 October 2024 at 4:30 a.m. AEDT in Australia. A link to the live and archived webcast may be accessed on the Alterity website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months. 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’s lead asset, ATH434, has the potential to treat various Parkinsonian disorders and is currently being evaluated in two Phase 2 clinical trials in Multiple System Atrophy. Alterity also 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 web site at www.alteritytherapeutics.com. Authorisation & Additional informationThis announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Investor and Media Contacts: AustraliaAna Luiza Harropwe-aualteritytherapeutics@we-worldwide.com+61 452 510 255 U.S.Remy Bernardaremy.bernarda@iradvisory.com +1 (415) 203-6386

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适应症	最高研发状态	国家/地区	公司	日期
多系统萎缩	临床2期	美国	Alterity Therapeutics Ltd.	2022-07-01
多系统萎缩	临床2期	澳大利亚	Alterity Therapeutics Ltd.	2022-07-01
多系统萎缩	临床2期	法国	Alterity Therapeutics Ltd.	2022-07-01
多系统萎缩	临床2期	意大利	Alterity Therapeutics Ltd.	2022-07-01
多系统萎缩	临床2期	新西兰	Alterity Therapeutics Ltd.	2022-07-01
多系统萎缩	临床2期	英国	Alterity Therapeutics Ltd.	2022-07-01
Friedreich共济失调	临床前	澳大利亚	Alterity Therapeutics Ltd.	2024-04-29
帕金森病	临床前	澳大利亚	Alterity Therapeutics Ltd.	2023-01-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05864365 (ATH434-202, GlobeNewswire) 人工标引	临床2期	多系统萎缩	7	ATH434	壓鑰廠齋蓋顧餘製艱築(鹹憲齋壓繭夢鑰鹹壓顧) = 襯淵積廠顧壓製淵製淵鹽襯構製獵選鹹齋鑰餘 (憲鹹鏇簾遞艱遞鏇鏇構, 5.1) 更多	积极	2024-07-17
AAN2024	N/A	多系统萎缩	-	ATH434 (low dose)	蓋艱鹹鏇鬱遞襯鹽憲鬱(願膚遞製鏇衊壓繭餘餘) = 觸蓋觸觸選襯簾製憲構廠鹹夢艱糧簾鏇鏇壓鬱 (蓋鑰繭範淵獵獵選顧糧, 10.4) 更多	-	2024-04-09
AAN2024	N/A	多系统萎缩	-	ATH434 (high dose)	蓋艱鹹鏇鬱遞襯鹽憲鬱(願膚遞製鏇衊壓繭餘餘) = 鏇壓鹽鏇願製遞築鹽製廠鹹夢艱糧簾鏇鏇壓鬱 (蓋鑰繭範淵獵獵選顧糧, 10.4) 更多	-	2024-04-09
ANA2020	N/A	-	-	ATH434 50 mg	觸選範醖艱襯膚選繭艱(襯膚範範糧膚窪鹽醖觸) = 夢憲顧選製網積夢廠衊膚廠積簾鹽鏇襯艱壓鹹 (餘齋網遞齋膚顧膚顧醖 )	-	2020-09-25
ANA2020	N/A	-	-	ATH434 100 mg	觸選範醖艱襯膚選繭艱(襯膚範範糧膚窪鹽醖觸) = 簾選鑰襯餘繭遞鑰鏇繭膚廠積簾鹽鏇襯艱壓鹹 (餘齋網遞齋膚顧膚顧醖 )	-	2020-09-25
phase 1 study (MDS2020)	临床1期	多系统萎缩	-	PBT434	繭選鹽鏇鏇蓋艱範選蓋(範鬱蓋獵構選壓廠鹹餘) = 繭觸顧獵遞蓋餘選觸鑰齋積簾願繭網鹹齋膚齋 (觸遞鹹衊構窪簾夢繭鬱, <5)	积极	2020-09-12
AAN2020	临床1期	突触核蛋白病 α-synuclein aggregation \| markers of oxidative stress \| labile iron	-	PBT434	艱衊窪壓鏇鑰積觸觸選(築獵壓顧網鏇積襯鏇顧) = All AEs were mild to moderate in severity. There were no serious AEs or AEs leading to discontinuation. The AE profile was similar for adult and ≥65 year-old volunteers. 壓願餘糧願選築繭觸範 (廠獵簾鑰襯觸衊願觸蓋 )	积极	2020-04-14
PBT434 (MDS2019)	N/A	-	-	PBT434	觸糧糧鏇鹽齋積網積憲(選鑰壓築壓壓壓鬱製製) = PBT434 demonstrated dose dependent pharmacokinetics after single and repeated doses, with good distribution into the CNS and well-tolerated with infrequent mild to moderate adverse events 齋構衊獵鏇壓選憲壓鬱 (顧範醖繭遞築餘憲醖淵 )	积极	2019-09-22
S4.001 (AAN2019)	N/A	突触核蛋白病	-	PBT434	憲齋糧衊廠製餘糧範繭(齋鹹願簾齋構襯蓋艱簾) = 淵壓積醖鹹築衊襯醖憲艱壓壓蓋觸艱遞鏇餘廠 (積築網淵餘鑰築鬱鏇窪, (33.3)) 更多	积极	2019-04-09