SparingVision Presents PRODYGY data and Research Update in Two Oral Presentations at ASGCT 2025
- Favorable safety profile and preliminary signs of efficacy observed in patients with severe advanced RP in ongoing Phase I/II PRODYGY trial
- Company also unveils novel triplex dPCR assay to improve detection and quantification of replication-competent AAV genomes in gene therapy products
Paris, 19 May 2025 – SparingVision (“the Company”), a clinical-stage genomic medicine company transforming the treatment of retinal disease, has presented on the podium updated safety data and new preliminary efficacy findings from its lead candidate, SPVN06, as well as a novel method to quantify replication-competent AAV genomes (rcAAVs) at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting taking place from 13-17 May 2025 in New Orleans, Louisiana, USA.
At time of data cutoff, a total of 11 patients had been treated in the PRODYGY Phase I/II study. Nine patients with severe advanced RP treated in Phase I with increasing doses of SPVN06 continue to show a favorable safety profile up to 1.5 years after dosing. No significant intraocular inflammation or immune responses were observed, and there were no serious adverse events, no dose-limiting toxicities, and no trial discontinuations. In step two of the trial (Phase II), which is ongoing in patients with intermediate advanced RP, preliminary safety data from the first two sentinel patients also showed a favorable safety profile one month after subretinal injection.
Preliminary efficacy data from Phase I of the PRODYGY study showed better outcomes in some of the treatment eyes as measured by Best Corrected Visual Acuity (BCVA) at two consecutive timepoints (six months apart) in three of the first six patients with severe advanced Retinitis Pigmentosa (RP) who had received the low or medium dose of SPVN06 and reached at least one year of follow-up at the time of data cutoff. The efficacy measurement in the open label, Phase I study will continue regularly, including for the high dose cohort which was not part of the analysis.
Daniel Chung, Chief Medical Officer of SparingVision, commented: “We are pleased to see that SPVN06 continues to demonstrate a favorable safety profile. We are also encouraged by the preliminary efficacy signals obtained from Phase I, although it is still too early to draw conclusions given the severity of the patients’ disease and the short follow-up period prior to data cutoff. We will continue to monitor closely safety and efficacy from the Phase I as we wait for Phase II data readout in 2026.”
Also presented at ASGCT was SparingVision’s triplex digital PCR (dPCR) assay, designed to detect and quantify rcAAVs, gene therapy product-related impurities that can arise during AAV manufacturing. Current rcAAV detection methods are often inconsistent and serotype-dependent. SparingVision’s new assay enables unbiased quantification across AAV serotypes, with the potential to enhance quality control and safety monitoring in the development of AAV-based gene therapies such as SPVN06.
Mehdi Gasmi, Chief Scientific Officer and Chief Technology Officer of SparingVision commented: “The development of our triplex dPCR assay represents a significant step forward in the unbiased detection and quantification of rcAAVs, significantly enhancing the quality control process and safety of AAV-based gene therapies like SPVN06. We look forward to continuing working with a broader consortium and the regulators to fully develop the potential of this new method.”
NOTES TO EDITORS
Contacts:
Investors: Nathalie Trepo (nathalie.trepo@sparingvision.com)
Media: ICR Healthcare (sparingvision@icrhealthcare.com)
About SparingVision
SparingVision is a clinical-stage genomic medicines company with a mission to translate pioneering science into vision saving treatments. Leveraging its unparalleled understanding of retinal diseases, SparingVision has built the world’s most compelling portfolio of synergistic cutting-edge gene therapy and genome editing treatments for blinding retinal diseases. Its most advanced products, SPVN06 and SPVN20 look to go beyond single gene correction therapies to deliver new mutation agnostic treatments for Retinitis Pigmentosa (RP) and geographic atrophy secondary to dry-AMD, two leading causes of blindness globally. The Company also has a strategic collaboration with Intellia Therapeutics (NASDAQ:NTLA) to develop novel genome editing-based treatments for ocular disease utilizing CRISPR-Cas9 technology.
SparingVision is a spin-off from the Paris Vision Institute and backed by high-quality investors including 4BIO Capital, Adbio Partners, Bpifrance, Retinal Degeneration Fund, the venture arm of the Foundation Fighting Blindness, Fondation Voir & Entendre, Intellia Therapeutics, UPMC Enterprises, Jeito Capital and Ysios Capital.
Visit www.sparingvision.com for more and follow us on LinkedIn and X @SparingVision