SparingVision Announces Presentation of SPVN06 Safety Data at the Macula Society 48th Annual Meeting
- Favorable safety profile of SPVN06 observed in Phase I including nine patients with severe advanced retinitis pigmentosa
- Trial advances into Phase II extension phase, with two highest doses of SPVN06, following DSMB positive recommendation
Paris, 13 February, 2025 – SparingVision (“the Company”), a clinical-stage genomic medicine company transforming the treatment of retinal disease, announces that Professor Isabelle Audo, one of the Principal Investigators of the PRODYGY Phase I/II clinical trial, presented the latest safety data, which showed a favorable safety profile of SPVN06, at the Macula Society 48th Annual Meeting, held February 12-15, 2025, in Charlotte Harbor, Florida, USA.
Results showed new, comprehensive safety data across all three dose-escalation cohorts, representing the most complete analysis of SPVN06 safety to date. The data demonstrated that administration of increasing doses of SPVN06 investigational gene therapy to nine patients with severe advanced retinitis pigmentosa maintains a favorable safety profile, with extended follow-up periods now reaching up to 1.5 years after injection for the low-dose (n=3), 1 year for the medium-dose cohorts (n=3), and between 3 and 9 months for the high-dose cohort (n=3).
Daniel Chung, Chief Medical Officer at SparingVision, said:
“The comprehensive safety data presented today reinforces the favorable safety profile of SPVN06 observed across all dose cohorts and multiple timepoints in the PRODYGY study. These results support our progression into the next phase of clinical development as we continue working to develop potential new treatment options for patients with retinitis pigmentosa.”
In all cohorts at all dose levels, no significant intraocular inflammation or immune response was reported, as well as no serious adverse events (SAEs), dose-limiting toxicities, or study discontinuations. Ocular adverse events observed were mostly moderate or mild in intensity, and procedure related.
Following comprehensive review of safety and tolerability data across all three dose cohorts, the independent Data Safety Monitoring Board (DSMB) recommended advancement to Phase II of the PRODYGY trial.
Phase II of PRODYGY, which will be conducted at six specialized clinical centers in the USA and France, will enroll and randomize 24 patients with intermediate retinitis pigmentosa, across three arms: high dose (n=9), medium dose (n=9) and one control arm of uninjected patients (n=6).
NOTES TO EDITORS
Contacts:
Investors: Nathalie Trepo (nathalie.trepo@sparingvision.com)
Media: ICR Healthcare (sparingvision@icrhealthcare.com)
DISCLAIMER
Dr. Jose-Alain Sahel and UPMC have a financial interest in SparingVision.
About SparingVision
SparingVision is a genomic medicines company with a mission to translate pioneering science into vision saving treatments. Leveraging its unparalleled understanding of retinal diseases, SparingVision has built a compelling portfolio of synergistic cutting-edge gene therapy and genome editing treatments for inherited retinal diseases (IRDs). Both of 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), a group of IRDs which are a leading cause 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
About SPVN06
SPVN06 is a proprietary, mutation-agnostic, AAV vector based investigational gene therapy approach comprised of one neurotrophic factor (Rod derived Cone Viability Factor, RdCVF) and one enzyme reducing oxidative stress (Rod derived Cone Viability Factor Long form, RdCVFL). Acting synergistically, RdCVF and RdCVFL aim at slowing or stopping the degeneration of cone photoreceptors, which inevitably leads to blindness in patients with rod-cone dystrophies (RCD). SparingVision’s primary disease target is retinitis pigmentosa (RP), one of the most common inherited retinal diseases that affects an estimated two million patients worldwide. There is currently no treatment approved to treat patients with RP independently of their genetic background. This approach is potentially applicable to many more diseases, where the loss of rods is known to be an early signal of the disease, notably Geographic Atrophy (GA) secondary to dry Age-related Macular Degeneration (AMD). SPVN06 is the result of world-leading ophthalmology research by SparingVision founders José-Alain Sahel and Thierry Léveillard at the Paris Vision Institute.
About PRODYGY
PRODYGY (Promising ROd-cone DYstrophy Gene therapY) 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 retinitis pigmentosa due to a mutation in the RHO, PDE6A, or PDE6B gene. Further information on the PRODYGY trial can be found on www.ClinicalTrials.gov(CT identifier: NCT05748873).