Iveric Bio, Inc. announced the release of data from an exploratory time-to-event analysis from the GATHER clinical development program assessing vision loss reduction with the use of avacincaptad pegol (ACP).
Tell me more about ACP.
As a novel investigational complement C5 inhibitor — overactivity of C5 protein and the complement system are thought to have a significant role in scarring and vision loss associated with geographic atrophy (GA) secondary to AMD. By targeting C5 protein, ACP may decrease activity in the complement system that leads to retinal cell degeneration and, as a result, slow GA progression.
Didn’t I just hear news about it?
You did! Iveric Bio announced last month that the FDA accepted its new drug application (NDA) submission of ACP, granted it Priority Review, and set a Prescription Drug User Fee Act (PDUFA) date for August 19, 2023.
The FDA also previously granted the compound breakthrough designation in November 2022.
What happened in the GATHER trials?
The GATHER1 and GATHER2 phase 3 clinical trials evaluated the safety and efficacy of 2 mg monthly intravitreal injections of ACP compared to sham.
Twelve-month data from the trials found ACP to be the only investigational product for treating GA that achieved its pre-specified 12-month primary endpoint, with efficacy rates observed up to 35%.
See here for details.
How about in this post-hoc analysis?
New data has found an up to 59% reduction in vision loss rate with ACP 2 mg when compared to sham treatment at 12 months, as defined by a loss of ≥15 letters Early Treatment Diabetic Retinopathy Study (EDTRS) in best-corrected visual acuity (BCVA) from baseline measured at any two consecutive visits up to month 12.
How does this compare to the GATHER trials?
The findings are independently on par with both the GATHER1 and GATHER2 trials, including a reduction of 44% (Hazard Ratio 0.56 with 95% CI, 0.15-2.06) and 59% (Hazard Ratio 0.41 with 95% CI, 0.17-1.00), respectively, in the rate of vision loss with ACP 2 mg.
An analysis of both GATHER trials found that ACP 2 mg-treated patients had a 56% reduction in rate of vision loss—when compared to sham-treated patients—during the first 12 months of treatment of GA secondary to AMD.