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

6 May 2024

AsclepiX Therapeutics, Inc., a clinical-stage biopharmaceutical company specializing in computational biology from Johns Hopkins to develop peptides for treating retinal diseases, has announced the completion of enrollment in the DISCOVER trial (NCT05859776). The trial for AXT107 (gersizangitide) has enrolled fifteen patients. The primary objectives 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 administered suprachoroidally. Secondary endpoints include efficacy measures like central subfield thickness (CST) and best-corrected visual acuity (BCVA). So far, there have been no safety concerns following a single injection of AXT107.

AsclepiX Therapeutics, expressed gratitude to the team and sites involved for their dedication, collaboration, and precise execution in enrolling patients. He attributed the rapid enrollment to the partnership with principal investigators Drs. David Almeida, William Bridges, Sabin Dang, and David Lally, recognizing their pivotal role in reaching this milestone for patients.

AXT107, AsclepiX’s lead clinical candidate, works through a novel mechanism by inhibiting neovascularization, reducing vascular permeability, and suppressing vascular inflammation. Administered as a microparticulate suspension suitable for suprachoroidal injection, AXT107 aims to sustain biological activity with a single injection, exceeding current standards of care.

AXT107 inhibits pro-angiogenic vascular endothelial growth factor receptor 2 (VEGFR2) and activates the vessel-stabilizing receptor tyrosine kinase (Tie2), both validated pathways for treating retinal vascular diseases. AXT107 interacts with integrin αvβ3 and integrin α5β1 to modulate these pathways. Formulated as a microparticulate suspension suitable for intraocular injection, AXT107’s Tie2 effects complement its anti-VEGF action, potentially leading to greater vision improvement, reduced vascular permeability, and inflammation suppression. Its inherent low aqueous solubility suggests substantial durability when administered intraocularly, promising to alleviate the treatment burden associated with current standards of care.

 

Source: globenewswire.com