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Trials |  |
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- | gersizangitide (AXT107) / Asclepix
Enrollment closed: DISCOVER: Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD) (clinicaltrials.gov) - May 5, 2024
P1/2, N=15, Active, not recruiting, Sponsor: AsclepiX Therapeutics, Inc.
Recruiting --> Active, not recruiting
- gersizangitide (AXT107) / Asclepix
Trial termination: CONGO: Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema (clinicaltrials.gov) - Mar 22, 2024
P1/2, N=6, Terminated, Sponsor: AsclepiX Therapeutics, Inc.
Recruiting --> Active, not recruiting Completed --> Terminated; Adverse Events
- gersizangitide (AXT107) / Asclepix
Trial termination: SHASTA: Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - Mar 22, 2024
P1/2, N=3, Terminated, Sponsor: AsclepiX Therapeutics, Inc.
Completed --> Terminated; Adverse Events Completed --> Terminated; Adverse Events
- || gersizangitide (AXT107) / Asclepix
Enrollment open: DISCOVER: Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD) (clinicaltrials.gov) - Dec 29, 2023
P1/2, N=15, Recruiting, Sponsor: AsclepiX Therapeutics, Inc.
Completed --> Terminated; Adverse Events Not yet recruiting --> Recruiting
- || gersizangitide (AXT107) / Asclepix
New P1/2 trial: DISCOVER: Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD) (clinicaltrials.gov) - May 16, 2023
P1/2, N=15, Not yet recruiting, Sponsor: AsclepiX Therapeutics, Inc.
- ||| gersizangitide (AXT107) / Asclepix
Trial completion, Enrollment change: SHASTA: Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - Nov 17, 2022
P1/2, N=3, Completed, Sponsor: AsclepiX Therapeutics, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | N=18 --> 3
- ||| gersizangitide (AXT107) / Asclepix
Trial completion, Enrollment change: CONGO: Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema (clinicaltrials.gov) - Nov 17, 2022
P1/2, N=6, Completed, Sponsor: AsclepiX Therapeutics, Inc.
Active, not recruiting --> Completed | N=18 --> 3 Active, not recruiting --> Completed | N=18 --> 6
- | gersizangitide (AXT107) / Asclepix
Trial completion date, Trial primary completion date: CONGO: Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema (clinicaltrials.gov) - Jul 20, 2022
P1/2, N=18, Active, not recruiting, Sponsor: AsclepiX Therapeutics, Inc.
Active, not recruiting --> Completed | N=18 --> 6 Trial completion date: Jul 2022 --> Oct 2022 | Trial primary completion date: Jul 2022 --> Oct 2022
- | gersizangitide (AXT107) / Asclepix
Enrollment closed: SHASTA: Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - Apr 29, 2022
P1/2, N=18, Active, not recruiting, Sponsor: AsclepiX Therapeutics, Inc.
Trial completion date: Jul 2022 --> Oct 2022 | Trial primary completion date: Jul 2022 --> Oct 2022 Recruiting --> Active, not recruiting
- | gersizangitide (AXT107) / Asclepix
Enrollment closed: CONGO: Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema (clinicaltrials.gov) - Apr 29, 2022
P1/2, N=18, Active, not recruiting, Sponsor: AsclepiX Therapeutics, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- | Journal: The emerging role of the angiopoietin-Tie pathway as therapeutic target for treating retinal diseases. (Pubmed Central) - Mar 3, 2022
Further clinical trials are necessary to define the role of agents targeting Ang/Tie in future clinical practice. Among the investigational drugs targeting the Ang/Tie pathway, faricimab has shown promising results in phase II/III trials and in the near future may represent a viable treatment option for the management of exudative macular diseases.
- AXT107 / Asclepix
[VIRTUAL] AXT107 an Inhibitor of Neovascularization, Vascular Leakage, and Inflammation, Is Well-Tolerated and Could Potentially Be Dosed Once a Year to Treat Retinal Vascular Diseases () - May 13, 2021 - Abstract #ARVO2021ARVO_3447;
PK and ocular distribution studies in rabbit and minipig showed that AXT107 formed a gel upon intravitreal injection that stayed below the visual axis releasing AXT107 slowly over the course of the study with a half-life of 180 days. The released AXT107 was found to be present at efficacious levels in the retina and choroidal tissues.
- | AXT107 / Asclepix
Journal: Suppression of Ocular Vascular Inflammation through Peptide-Mediated Activation of Angiopoietin-Tie2 Signaling. (Pubmed Central) - Mar 5, 2021
AXT107 also decreased the levels of pro-inflammatory TNF receptor 1 (TNFR1) without affecting levels of the more protective TNFR2. These data suggest that AXT107 may provide multiple benefits in the treatment of retinal/choroidal and other vascular diseases by suppressing inflammation and promoting vascular stabilization.
- AXT107 / Asclepix
[VIRTUAL] AXT107, a Gel Forming Peptide that Inhibits VEGFR2 Signaling and Activates Tie2 Signaling for the Treatment of Retinal Vascular Diseases () - Feb 11, 2021 - Abstract #Macula2021Macula_171;
- AXT107 / Asclepix
[VIRTUAL] AXT107, an Inhibitor of Integrins ?v?3 and ?5?1 that Blocks VEGF Signaling, Activates Tie2, and Suppresses Inflammation, Inhibits Ocular Neovascularization and Vascular Leakage () - Feb 11, 2021 - Abstract #Macula2021Macula_89;
- || gersizangitide (AXT107) / Asclepix
New P1/2 trial: SHASTA: Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - Feb 9, 2021
P1/2, N=18, Recruiting, Sponsor: AsclepiX Therapeutics, Inc.
- | Journal: Anti-Integrin therapy for retinovascular diseases. (Pubmed Central) - Feb 3, 2021
Preclinical candidates include SB-267268, AXT-107, JNJ-26076713, Cilengitide and Lebecetin, which exhibit a decrease in retinal permeability, angiogenesis and/or choroidal neovascularization (CNV)...Anti-integrin agents tackle the multi-factorial nature of DR and AMD and show promise as injectable and topical agents in preclinical and early clinical studies. Integrin inhibition has potential to serve as primary therapy, adjunctive therapy to anti-vascular endothelial growth factor agents, or secondary therapy in refractory cases.
- | gersizangitide (AXT107) / Asclepix
New P1/2 trial: CONGO: Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema (clinicaltrials.gov) - Jan 5, 2021
P1/2, N=18, Recruiting, Sponsor: AsclepiX Therapeutics, Inc.
- || faricimab (RG7716) / Roche, AXT107 / Asclepix
Review, Journal: The Tie2 signaling pathway in retinal vascular diseases: a novel therapeutic target in the eye. (Pubmed Central) - Oct 20, 2020
Tie2 activation only modestly impacts angiogenesis on its own but significantly potentiates VEGF suppression. Co-regulation of the VEGF and Tie2 signaling pathways has the potential to improve functional and structural outcomes in eyes with retinal vascular diseases.
- | AXT107 / Asclepix
Journal: A collagen IV-derived peptide disrupts α5β1 integrin and potentiates Ang2-Tie2 signaling. (Pubmed Central) - May 13, 2020
The potentiation of Tie2 activation by Ang2 even extended in to mouse models in which AXT107 induced Tie2 phosphorylation in a model of hypoxia and inhibited vascular leakage in an Ang2-overexpression transgenic model and an LPS-induced inflammation model. Since Ang2 levels are very high in ischemic diseases, such as diabetic macular edema, neovascular age-related macular degeneration, uveitis, and cancer, targeting α5β1 with AXT107 provides a novel and potentially more effective approach to treat these diseases.