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SparingVision Reaches Final Dose Escalation Step in PRODYGY Trial with SPVN06 for retinitis pigmentosa
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According to the company, favorable safety and tolerability profiles were observed with the first 2 SPVN06 doses across 6 patients. The exploration of SPVN06 in geographic geographic atrophy is set to begin in 2024.
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SparingVision announced a key advancement in its PRODYGY Phase I/II clinical trial (NCT05748873) for SPVN06, the company’s lead gene-agnostic investigational gene therapy for the treatment of retinitis pigmentosa (RP).
According to a news release,1 the trial has now progressed to the final dose cohort of the dose-escalation phase (Part 1). This positive recommendation from the Data Safety Monitoring Board (DSMB) represents a further step towards the commencement of the controlled part of the study (Part 2) anticipated to start in Q2 2024, in line with study development timelines.
The company noted that SPVN06 is a gene therapy approach aimed at stopping or slowing disease progression in patients affected by rod-cone dystrophy, (RCD), regardless of their genetic background. SparingVision is initially focusing on mid-stage RP, one of the leading inherited causes of blindness globally.1
Moreover, the company noted the progress of the PRODYGY trial to the 3rd cohort at the highest dose of SPVN06 follows an earlier positive recommendation from the DSMB to dose the second cohort at the medium dose in August 2023. The 2 positive recommendations received to date from the DSMB were based on the favorable safety and tolerability profiles observed in patients treated with the lower (first cohort) and medium (second cohort) doses of SPVN06. After completion of the third and final cohort in Part 1, the company plans to advance the PRODYGY trial to Part 2, a 3-arm controlled, double-masked, randomized extension phase investigating 2 doses of SPVN06 and 1 untreated arm, with additional clinical sites opening in the United States.1
The primary endpoint of the PRODYGY Phase I/II trial is expected to be reached in the second half of 2025, twelve months after the last patient in Part 2 is dosed, according to the news release.
Stéphane Boissel, president and CEO of SparingVision, noted the company is encouraged by the strong safety and tolerability profile of SPVN06 demonstrated so far.
“This milestone not only allows us to progress to the highest dose and, pending further DSMB positive recommendation, start Part 2 in Q2 2024; it also gives us the added confidence to expand the evaluation of SPVN06 to geographic atrophy (GA), another significant blinding condition” Boissel said in the news release. “We are excited about the future as we continue to advance our portfolio of pioneering genomic medicines to save sight.”
With the encouraging safety data gathered in PRODYGY so far and supported by a body of evidence and KOL insights, SparingVision believes in the strong potential of SPVN06 in other retinal diseases for which cone preservation is the landmark for stopping disease progression. The Company intends to explore the benefits of its gene therapy for the treatment of geographic atrophy (GA), with a view to potentially initiating Investigational New Drug (IND)-enabling studies for GA in 2024.1
PRODYGY trial
According to the company, PRODYGY is a multicentric Phase I/II trial to assess the safety, tolerability as well as preliminary efficacy and quality-of-life following a single subretinal injection of SPVN06 in the worst-seeing eye of adult patients with RCD due to a mutation in the RHO, PDE6A, or PDE6B gene. The study aims to recruit a total of 33 patients in two parts:
- Part 1: open-label, dose-escalation phase including three cohorts of three patients with severe advanced RCD, to determine two recommended best-tolerated doses for Part Two.
- Part 2: controlled, double-masked, randomized extension phase including 24 patients with intermediate-advanced RP, divided into three cohorts: six untreated subjects and 18 patients receiving one of the two recommended doses determined in Part One.
