AsclepiX Therapeutics Completes DISCOVER Trial Enrollment for Wet AMD Treatment
AsclepiX Therapeutics has successfully completed the enrollment for the DISCOVER trial (NCT05859776), which evaluates the safety and tolerability of three different doses of AXT107 (gersizangitide) in patients with wet Age-related Macular Degeneration (AMD).
Trial Design and Objectives
The trial includes 15 participants who are receiving doses of 125 µg (n=3), 250 µg (n=3), or 500 µg (n=9) of AXT107. This study aims to assess not only the safety and tolerability but also the bioactivity and duration of action of AXT107 when administered suprachoroidally. Secondary endpoints of the study include the efficacy measured by central subfield thickness (CST) and best-corrected visual acuity (BCVA). Remarkably, no significant safety issues have been observed following the single injection of AXT107.
Robert J. Dempsey, the Chief Executive Officer of AsclepiX Therapeutics, expressed his gratitude for the team's effort in a recent press release. “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,” Dempsey said. He highlighted the rapid enrollment as a testament to the partnership with the principal investigators, Drs. David Almeida, William Bridges, Sabin Dang, and David Lally, who have been instrumental in reaching this pivotal milestone for patients.
Novel Treatment Approach
AXT107, the leading clinical candidate from AsclepiX, introduces a novel approach to treatment by regulating integrin peptides. This mechanism effectively inhibits neovascularization, reduces vascular permeability, and suppresses vascular inflammation. Designed as a microparticulate suspension for suprachoroidal injection, AXT107 aims to maintain sustained biological activity with a single injection, significantly extending beyond the current standard of care in wet AMD treatment.
About Wet AMD
Wet age-related macular degeneration is a chronic eye disorder that represents one of the leading causes of vision loss in older adults. This condition is characterized by the growth of abnormal blood vessels under the macula, the part of the retina responsible for clear, central vision. These vessels are fragile and leak fluid and blood, leading to swelling and damage to the macula. As a result, wet AMD causes a rapid loss of central vision, which is crucial for activities like reading, driving, and recognizing faces.
Unlike its counterpart, dry AMD, which progresses more slowly, wet AMD can lead to significant visual impairment within a short period. Current treatments focus on inhibiting the growth of these abnormal blood vessels, typically through regular injections of anti-VEGF (vascular endothelial growth factor) drugs into the eye, which help reduce vessel permeability and slow the progression of the disease.
