A phase two clinical study of a new compound known as ALP-2 offers new hope for vision maintenance of patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD).
GA lesion growth in patients given injections of the compound, developed by Apellis Pharmaceuticals, either monthly or every other month for 12 months, was reduced by 29 per cent and 20 per cent respectively, compared to control patients.
The 246 patient Phase 2 multicentre, randomised, single-masked, sham-controlled clinical trial of APL-2 in patients with GA (known as the FILLY trial) was sponsored by Apellis Pharmaceuticals. It was conducted at 40 clinical sites, located in the United States, Australia and New Zealand.
At 12 months, APL-2, administered monthly via intravitreal injection, showed a 29 per cent (p=0.008) reduction in the rate of GA lesion growth compared to sham. With every other month administration, a 20 per cent (p=0.067) reduction was observed. Additionally, in a post hoc analysis, a greater effect was observed during the second six months of the study: a reduction in growth rate of 47 per cent (p<0.001) with monthly administration, and a reduction of 33 per cent (p=0.01) with every other month administration.
The most frequently reported adverse events in the study were associated with the injection procedure
The most frequently reported adverse events in the study were associated with the injection procedure. A higher incidence of exudative AMD was observed in the treatment groups, predominantly in subjects with a history of exudative AMD in the fellow eye, and was managed with the administration of standard-of-care therapies.
Principal Investigator Robyn Guymer from CERA and the University of Melbourne said she was delighted with the results. “In the past decade, we have made tremendous advances in treating one of the late complications of AMD which is called wet AMD, where blood vessels leak in the back of the eye and destroy vision rapidly,” said Professor Guymer.
“Now we are directing our attention to treating the other irreversible late complication of AMD, called dry AMD or geographic atrophy (GA).”
Professor Cedric Francois, founder and chief executive officer of Apellis said, “In addition to demonstrating a statistically significant slowing of disease over 12 months, APL-2’s effect appears to increase in the second six months of the study, slowing down the rate of degeneration by almost half. We plan to move forward with Phase 3 studies as soon as possible.”
David Boyer, MD, of Retina-Vitreous Associates Medical Group, said, “These results are very exciting for all people afflicted with dry AMD with geographic atrophy. It is currently an untreatable condition, and the reduction of the progression of atrophy in this trial offers new hope for vision maintenance for our patients.”
Based on the positive results, Apellis plans to proceed with Phase 3 studies as soon as possible.