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APL-2 Meets Primary Endpoint In AMD Patients With Geography Atrophy
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The C3 inhibitor showed a 29% reduction in geography atrophy over a 1-year period.
APL-2, a complement C3 inhibitor, has met its primary endpoint in its phase 2 clinical trial, reducing the rate of geographic atrophy (GA) associated with age-related macular degeneration (AMD).
At the 1-year mark, the intravitreal APL-2 injection showed a 29% reduction in GA lesion growth rates (p=0.008) when compared to the sham injection arm. A 20% reduction (p<0.001) was noted with every other month injections.
When analyzed post hoc, APL-2 performed better as time went on, showing a reduction in growth rate of 47% (p<0.001) with a monthly administration, and a reduction of 33% (p=0.01) with every other month administration in the second 6 months of the study.
“We are very excited about the results of this study,” Cedric Francois, MD, PhD, founder and chief executive officer of Apellis, said in a statement. “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.”
The drug, manufactured by Apellis Pharmaceuticals, did see some adverse events, but the most frequently reported were related to the injection procedure. Exudative AMD occurred at a higher rate in the treatment group, most predominately in patients with a history of exudative AMD in the fellow eye. It was managed with standard-of-care therapies.
“These results are very exciting for all people afflicted with dry AMD with geographic atrophy,” David Boyer (pictured), MD, of Retina-Vitreous Associates Medical Group, said in a statement. “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.”
Boyer told MD Magazine that the C3 inhibitor is “extremely exciting” with a “proven mode of action,” highlighting its potential for the treatment of geography atrophy.
