PRODYGY Trial: SparingVision Advances to Final Dose of SPVN06 for RP

SparingVision, a genomic medicine company specializing in retinal disease treatments, has achieved a significant milestone in its Phase I/II clinical trial for SPVN06, a novel gene therapy for retinitis pigmentosa (RP). The trial has successfully reached the final dose level in the dose-escalation phase, following a positive endorsement from the Data Safety Monitoring Board (DSMB). This advancement is a step towards the controlled phase of the study, which is expected to commence in the second quarter of 2024.
The SPVN06 therapy is designed to halt or reduce the progression of rod-cone dystrophy (RCD) in patients, irrespective of their genetic makeup. The company is initially targeting mid-stage RP, a major cause of inherited blindness. The DSMB's recommendation to proceed to the highest dose level was based on the favorable safety and tolerability observed in patients who received the initial and medium doses of SPVN06. Upon completing the final cohort, SparingVision plans to enter the trial's controlled phase, which will involve additional clinical sites in the United States and is aimed at evaluating two doses of SPVN06 against an untreated control group. The primary endpoint for the PRODYGY trial is projected for the latter half of 2025.
Stéphane Boissel, CEO of SparingVision, expressed optimism regarding the safety profile of SPVN06 and the potential to extend its evaluation to geographic atrophy (GA), another significant cause of blindness. The company is encouraged by the safety data and is considering initiating Investigational New Drug (IND)-enabling studies for GA in 2024.
The PRODYGY trial is a multicenter study designed to assess the safety, tolerability, and preliminary efficacy of a single subretinal injection of SPVN06 in adult patients with RCD due to specific gene mutations. The trial is divided into two parts: an open-label dose-escalation phase and a controlled, double-masked, randomized extension phase. The study aims to recruit 33 patients in total.
SparingVision is a global leader in ophthalmology, offering new hope for millions affected by retinal diseases. The company's product portfolio includes SPVN06 and SPVN20, which provide gene-agnostic treatments for Retinitis Pigmentosa. SparingVision also collaborates with Intellia Therapeutics to develop novel genome editing treatments using CRISPR-Cas9 technology. The company is backed by a consortium of international investors and is a spin-off from the Paris Vision Institute.