Sylentis, a PharmaMar Group company, begins a new Phase II trial with SYL1801 for patients with Age-Related Macular Degeneration
2022-11-23 · PharmaMar · original pharmamar.com ↗
Sylentis, a PharmaMar Group Company (MSE:PHM), has announced today the recruitment of the first patient in a new Phase II dose-ranging trial with its compound SYL1801, for the treatment of patients with neovascular Age-related Macular Degeneration (AMD). This is a randomized, double-blind Phase II trial with three parallel groups in which different dose levels will be administered to each cohort of subjects. The study has been initiated already and will enroll a total of 90 patients at different centers in several European countries. The primary endpoint of the trial is to evaluate the effect on visual acuity of SYL1801 at all three doses, administered as a daily drop for 6 weeks in patients with neovascular AMD. In addition, secondary endpoints on disease progression and safety of SYL1801 will be evaluated. SYL1801 represents a potential breakthrough in the development of innovative drugs through gene silencing technology based on RNA interference (RNAi): its administration in the form of eye drops blocks the synthesis of the NRARP receptor (Notch-Regulated Antichiral Repeat Domain Proteins), which is involved in choroidal neovascularization (AMD pathology) and could change the standard of care for this disease. Currently, neovascular AMD is treated with regular eye injections of anti-VEGF agents, a very uncomfortable procedure for patients and a large investment in resources for healthcare systems. The application of SYL1801 in the form of eye drops could be a new therapeutic option for the treatment of retinal diseases involving a neovascularization processes. Age-Related Macular Degeneration (AMD) It is estimated that the number of individuals with AMD will reach 288 million in 2040. AMD is the leading cause of irreversible visual impairment in the elderly population of developed countries, accounting for 8% of all cases of blindness worldwide. The overall prevalence of AMD among 45-85 year olds is 8.7%.
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