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On September 9, Apellis announced the top-line results obtained in two phase 3 clinical trials, DERBY and OAKS, in the research pegcetacoplan targeting the complement C3 protein
.
Two trials evaluated the efficacy and safety of pegcetacoplan in 1258 adult patients with age-related macular degeneration (AMD) with geographic atrophy (GA) through intravitreal injection of pegcetacoplan
GA is an advanced form of AMD, and AMD is the main cause of blindness
.
GA disease affects the central part of the retina called the macula, which is responsible for central vision
GA occurs because of the excessive activation of the complement cascade in the immune system, and complement C3 is an effective target for precise regulation of complement activation
.
Pegcetacoplan is a C3 targeted therapy that has previously been granted Fast Track status by the US FDA for the treatment of GA
▲The mechanism of action of Pegcetacoplan (APL-2) (Image source: Apellis official website)
The test results showed that the OAKS test reached the primary endpoint
.
That is, at 12 months, compared with the control group, pegcetacoplan administered once a month or once every two months significantly reduced the growth of GA lesions by 22% (p=0.
A scheduled analysis combining the data of the two trials showed that at 12 months, compared with the control group, the administration of pegcetacoplan once a month or every two months reduced the growth of GA lesions by 17% (p<0.
0001) and 14% (p=0.
0012)
.
Moreover, in the pre-analysis of the primary endpoint, pegcetacoplan showed greater utility in patients with extrafoveal lesions at baseline
.
GA patients usually present with lesions outside the fovea first, and then progress to the fovea where central vision is affected
Note: The original text has been deleted
Reference materials:
[1] Apellis Announces Top-Line Results from Phase 3 DERBY and OAKS Studies in Geographic Atrophy (GA) and Plans to Submit NDA to FDA in the First Half of 2022.
