Drugs / fosgonimeton
fosgonimeton
also known as
ATH-1017 · ATH-1017 FREE ACID · ATH-1017 sodium · FOSGONIMETON SODIUM · NDX-1017 · NDX-1017 FREE ACID · NDX-1017 sodium
Small molecule targets HGF, MET via activation
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT05511558 | Jul → Oct 2022 | — | LeonaBio | Completed | No outcome recorded |
| Phase 1 | NCT03298672 | Oct 2017 → Sep 2019 | Alzheimer disease | LeonaBio | Completed | Met primary |
| Phase 22 trials · 2 missed | ||||||
| Phase 2 | NCT04831281 | Jan 2022 → Apr 2023 | Lewy body dementia, Parkinson disease | LeonaBio | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT04491006 | Nov 2020 → May 2022 | Alzheimer disease | LeonaBio | Completed | Missed primary |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT04886063 | Jun 2021 → Oct 2024 | Alzheimer disease | LeonaBio | Terminated | No outcome recorded |
| Phase 2/3 | NCT04488419 | Sep 2020 → Jul 2024 | Alzheimer disease | LeonaBio | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2024-09-03 | LeonaBio | Results Athira Pharma Announces Topline Results from Phase 2/3 LIFT-AD Clinical Trial of Fosgonimeton for Mild-to-Moderate Alzheimer’s Disease leonabio.com ↗
LIFT-AD trial did not meet primary endpoint of GST and key secondary endpoints of cognition (ADAS-Cog11) and function (ADCS-ADL23) |
| 2024-07-31 | LeonaBio | Results Athira Pharma Presents Preclinical Data Demonstrating New Insights into the Mechanism by Which Fosgonimeton Protects Neurons from Alzheimer’s Disease-Related Pathology at the Alzheimer’s Association International Conference (AAIC) 2024 leonabio.com ↗
We also demonstrated that the neuroprotective ability of fosgonimeton against amyloid-β-induced toxicity in primary neurons is maintained in the presence of lecanemab, and, in some conditions, the combination of fosgonimeton and lecanemab led to numerically higher levels of neuroprotection |
| 2024-04-11 | LeonaBio | Results Athira Pharma Announces Publication of Preclinical Data Highlighting Fosgonimeton Treatment in Models of Alzheimer’s Disease leonabio.com ↗ |
| 2024-03-08 | LeonaBio | Results Athira Pharma Presents Clinical and Preclinical Data Supporting Therapeutic Potential of Fosgonimeton in Alzheimer’s and Parkinson’s Diseases at AD/PD™ 2024 International Conference leonabio.com ↗
Results from exploratory SHAPE Phase 2 trial show encouraging safety and pro-cognitive measures with fosgonimeton treatment and underscore confidence in Phase 2/3 LIFT-AD trial with data anticipated in the second half of 2024 |
| 2023-12-12 | LeonaBio | Results Athira Pharma Announces Encouraging Results from SHAPE Phase 2 Clinical Trial of Fosgonimeton for the Treatment of Parkinson's Disease Dementia and Dementia with Lewy Bodies leonabio.com ↗
These findings support the potential of targeting HGF system positive modulation as a broadly applicable strategy for treating neurodegenerative diseases. |
| 2023-11-15 | LeonaBio | Results Athira Pharma Presents Preclinical Data Highlighting Fosgonimeton’s Neuroprotective Effects Against Amyloid-β-Induced Pathological Alterations and Neuroinflammation in Models of Alzheimer’s Disease leonabio.com ↗
Our latest data demonstrate consistent neuroprotective effects of fosgonimeton and provide insights into the mechanisms by which it preserves neurons from degeneration and reduces neuroinflammation. |
| 2023-07-17 | LeonaBio | Results Athira Pharma Presents Phase 2 Clinical Data Correlating Improvements in Biomarkers of Neurodegeneration and Neuroinflammation with Improvements in Measures of Cognition and Function in Alzheimer’s Disease leonabio.com ↗ |
| 2023-04-25 | LeonaBio | Results Athira Pharma Presents New Clinical and Preclinical Data at the American Academy of Neurology (AAN) 2023 Annual Meeting leonabio.com ↗
We are pleased to report that a post hoc analysis showed statistically significant improvements in Mini-Mental State Exam (MMSE) scores in patients treated with fosgonimeton without concomitant acetylcholinesterase inhibitors (AChEIs) in the exploratory six month Phase 2 ACT-AD trial |
| 2023-03-28 | LeonaBio | Results Athira Pharma Presents Preclinical Data Supporting Therapeutic Potential of Fosgonimeton for Alzheimer’s and Parkinson’s Diseases at AD/PD™ 2023 International Conference leonabio.com ↗
These findings include notable neuroprotective, neurotrophic, and anti-inflammatory effects, as well as reduction of disease-related protein pathologies following multiple and varied challenges in models of Alzheimer’s and Parkinson’s. |
| 2022-12-21 | LeonaBio | Results Athira Pharma Announces Publication of Fosgonimeton Preclinical Results in Neurotherapeutics leonabio.com ↗
Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced the publication of preclinical data demonstrating the neuroprotective, neurotrophic and procognitive effects of fosgonimeton (ATH-1017) in preclinical models. |
| 2022-11-29 | LeonaBio | Results Athira Pharma Highlights Therapeutic Potential of Fosgonimeton in Presentation of Additional Biomarker Data in Mild-to-Moderate Alzheimer’s Disease Patients from ACT-AD Phase 2 Study at CTAD Conference leonabio.com ↗ |
| 2022-11-21 | LeonaBio | Results Athira Pharma to Present Additional Biomarker Data from ACT-AD Phase 2 Study of Fosgonimeton at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) Conference leonabio.com ↗
Fosgonimeton demonstrates improvement on diverse biomarkers of neurodegeneration |
| 2022-11-16 | LeonaBio | Results Athira Pharma Presents Preclinical Data Supporting Therapeutic Potential of HGF/MET Platform at Neuroscience 2022 Conference leonabio.com ↗
The data presented at Neuroscience 2022 show that fosgonimeton (ATH-1017) promotes neuroprotection, reduces alpha-synuclein aggregation in vitro, and improves motor performance in animal models of Parkinson’s disease. |
| 2022-10-17 | LeonaBio | Results Athira Pharma Advances Phase 2/3 LIFT-AD Clinical Study of Fosgonimeton in Mild-to-Moderate Alzheimer’s Patients Following Independent, Unblinded Interim Analysis leonabio.com ↗
Results support potential clinically meaningful activity of fosgonimeton without background therapy and mitigate program risk |
| 2022-08-03 | LeonaBio | Results Athira Pharma Presents Data from ACT-AD Phase 2 Proof-of-Concept Clinical Study of Fosgonimeton in Mild-to-Moderate Alzheimer’s Patients at the Alzheimer's Association International Conference 2022 leonabio.com ↗
While the primary outcome analysis (mITT, MMRM) did not reach statistical significance, these data have given us meaningful insights into fosgonimeton’s potential effects. |
| 2022-08-02 | LeonaBio | Results Athira Pharma Presents Preclinical Data at the Alzheimer's Association International Conference 2022 leonabio.com ↗
The first poster presentation: “Fosgonimeton, a novel, small molecule positive modulator of the HGF/MET system is neuroprotective in primary neuron culture” (Poster #: 65874) demonstrated that fosgo-AM, the active metabolite of Athira’s lead pipeline candidate, fosgonimeton (ATH-1017), promotes neurotrophic effects and offers protection against neurological insults central to neurodegeneration. |
| 2022-06-22 | LeonaBio | Results Athira Pharma Announces Topline Results from ACT-AD Phase 2 Proof of Concept Study of Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease leonabio.com ↗
Primary endpoint of change in biomarker ERP P300 latency was not statistically significant for the full study population as combination of fosgonimeton and standard-of-care (AChEIs) given together showed potential diminished effect of fosgonimeton |
| 2022-03-20 | LeonaBio | Results Athira Pharma Presents Study Overview and Baseline Data from ACT-AD Phase 2 Trial of Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease at the 2022 AD/PD™ Congress leonabio.com ↗
The preliminary baseline ERP P300 latency is 381 milliseconds. |
| 2022-03-02 | LeonaBio | Results Athira Pharma Presents Preclinical Data of Fosgonimeton (ATH-1017) and ATH-1020 at the American Society for Experimental Neurotherapeutics (ASENT) Annual Meeting leonabio.com ↗
These in vitro findings with the active metabolite of fosgonimeton demonstrate the mechanism of action is through positive modulation of HGF/MET. |
| 2022-02-22 | LeonaBio | Results Athira Pharma Announces Publication of Phase 1 Results for Fosgonimeton (ATH-1017) in The Journal of Alzheimer's Disease leonabio.com ↗
today announced the peer-reviewed publication of data from a Phase 1 clinical trial of fosgonimeton (ATH-1017) in The Journal of Alzheimer's Disease. |
| 2021-11-10 | LeonaBio | Results Athira Pharma Presents Overview and Update from ACT-AD and LIFT-AD Trials of ATH-1017 in mild-to-moderate Alzheimer’s Disease at CTAD Conference leonabio.com ↗ |
| 2019-12-09 | LeonaBio | Results Athira Pharma Presents Positive Data for NDX-1017 in Alzheimer's Patients at 2019 Clinical Trials on Alzheimer's Disease (CTAD) Conference leonabio.com ↗
The company presented promising initial results using noninvasive biomarkers to evaluate effects of NDX-1017 on brain activity in Alzheimer's disease. |
| 2019-07-16 | LeonaBio | Results Athira Pharma Presents Preliminary Results from Phase 1 Trial of NDX-1017 at Alzheimer's Association International Conference 2019 (AAIC) leonabio.com ↗
Results from the Phase 1a and Phase 1b portions of the trial in 72 healthy young and elderly individuals demonstrated that NDX-1017 is safe and well-tolerated at multiple dose levels. |
All press releases naming this drug 39 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fosgonimeton | “This study is designed to evaluate the safety and treatment effects of fosgonimeton (ATH-1017) in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with...” NCT04831281 ↗4“This study is designed to evaluate treatment effects of ATH-1017 (fosgonimeton) in mild to moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks.” NCT04491006 ↗ “Fosgonimeton is a small-molecule positive modulator of the HGF system that has demonstrated neurotrophic and pro-cognitive effects in preclinical models of dementia.” PMID 38599894 ↗ Apr 2024 “Fosgonimeton is a small-molecule positive modulator of the HGF system that has demonstrated neurotrophic and pro-cognitive effects in preclinical models of dementia.” PMID 38599894 ↗ Apr 2024 |
| Known as | ATH-1017 | “The objective of this study is to determine the safety and tolerability of fosgonimeton (ATH-1017) in subjects with mild to moderate Alzheimer's disease who completed the...” NCT04886063 ↗ |
| Known as | ATH-1017 FREE ACID | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095419 ↗ |
| Known as | ATH-1017 sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095419 ↗ |
| Known as | FOSGONIMETON SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095419 ↗ |
| Known as | NDX-1017 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03298672 ↗ |
| Known as | NDX-1017 FREE ACID | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095419 ↗ |
| Known as | NDX-1017 sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095419 ↗ |
| Action | Activate | “Positive Modulator of HGF/MET” PMID 35180125 ↗ 2022 |
| Modality | Small molecule | “Fosgonimeton is a small-molecule positive modulator of the HGF system” PMID 38599894 ↗ Apr 2024 |
| Route | Subcutaneous | “via subcutaneous injection” NCT03298672 ↗ |
| Target | HGF | “Modulator of HGF/MET” PMID 35180125 ↗ 2022 |
| Target | MET | “Modulator of HGF/MET” PMID 35180125 ↗ 2022 |