AsclepiX Therapeutics Completes Enrollment in DISCOVER Trial for Neovascular Age-Related Macular Degeneration (nAMD)

2024-05-06

临床研究

The DISCOVER Phase 1/2a trial is an open-label, single ascending dose, 9-month study that will evaluate the safety and bioactivity of AXT107 (gersizangitide) injected suprachoroidally in patients with nAMD The trial was initiated in December 2023 to evaluate the safety, tolerability, and biologic activity of AXT107, with topline results expected in Q2 2025 BETHESDA, Md., May 06, 2024 (GLOBE NEWSWIRE) -- AsclepiX Therapeutics, Inc., a clinical-stage biopharmaceutical company leveraging computational biology from Johns Hopkins to identify and develop peptides for improved treatments of retinal diseases, today announced the completion of enrollment into the DISCOVER trial (NCT05859776). Fifteen patients have completed enrollment in the trial for AXT107 (gersizangitide). The objectives of the trial are to evaluate the safety and tolerability of three dose strengths of AXT107 [125 µg (n=3), 250 µg (n=3), and 500 µg (n=9)] and to determine the bioactivity and duration of action when injected suprachoroidally. Secondary endpoints will include efficacy as assessed by central subfield thickness (CST) and best-corrected visual acuity (BCVA). Following a single injection of AXT107, to date, no patient has shown any remarkable safety findings. “I would like to thank the team and sites for their unwavering commitment, collaborative spirit, and meticulous execution they brought to the enrollment of the DISCOVER trial,” said Robert J. Dempsey, Chief Executive Officer, AsclepiX Therapeutics. “Rapid enrollment was a tribute to the partnership of our principal investigators Drs. David Almeida, William Bridges, Sabin Dang, and David Lally who played a critical role in achieving this significant milestone for patients.” AsclepiX’s lead clinical candidate, integrin regulating peptide AXT107, has a novel mechanism of action that inhibits neovascularization, reduces vascular permeability, and suppresses vascular inflammation. Given as a microparticulate suspension suitable for suprachoroidal injection, AXT107 is designed to maintain sustained biological activity with one injection well beyond the current standard of care. About AXT107 AXT107 inhibits pro-angiogenic vascular endothelial growth factor receptor 2 (VEGFR2) and activates the vessel stabilizing receptor tyrosine kinase (Tie2), the two validated pathways for the treatment of retinal vascular diseases. Both pathways are mediated by the interaction of AXT107 with integrin αvβ3 and integrin α5β1. AXT107 is formulated as a microparticulate suspension suitable for intraocular injection. The Tie2 effects of AXT107 complement those of the anti-VEGF action, with the potential to have greater improvement in vision gains as well as reduction of vascular permeability and suppression of inflammation. Due to its inherent low aqueous solubility, AXT107 administered intraocularly can potentially provide substantial durability, which could dramatically reduce the treatment burden associated with the current standard of care. About AsclepiX Therapeutics, Inc. AsclepiX Therapeutics, Inc. is a clinical-stage biopharmaceutical company using computational biology to identify potent peptide regulators of vascular homeostasis with the lead candidate, AXT107, in retinal diseases. AsclepiX was founded by Johns Hopkins University School of Medicine researchers, initially licensing their groundbreaking portfolio of vascular homeostatic peptides and technologies. For more information, please visit: AsclepiX Media Contact: Christie Markowitz cmarkowitz@asclepix.com Source: AsclepiX Therapeutics, Inc.

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