SparingVision Doses First Patient in NYRVANA RP Trial

SparingVision has officially dosed the first patient in its NYRVANA clinical trial, a first-in-human study evaluating SPVN20, an investigational gene therapy for patients with advanced retinitis pigmentosa (RP). This milestone marks a significant advancement in the company's clinical pipeline aimed at treating inherited retinal diseases with no current curative options.

About the NYRVANA Trial

The NYRVANA trial is a multicenter, open-label, dose-escalation Phase 1/2 study designed to evaluate the safety, tolerability, and preliminary efficacy of a single intravitreal injection of SPVN20. While the initial study duration is 6 months, participants will be followed for long-term outcomes over a 5-year period.

SparingVision has confirmed that safety and efficacy data from the study will be collected and analyzed throughout 2026 and 2027, offering critical insights into the therapeutic potential of SPVN20.

SPVN20: A Gene-Agnostic, Intravitreal AAV-Based Therapy

SPVN20 is a gene-agnostic gene therapy candidate, meaning it is designed to treat RP regardless of the specific genetic mutation. Administered through a single intravitreal injection, SPVN20 uses an AAV vector to deliver a gene encoding a human G protein-gated inwardly rectifying potassium (GIRK) channel.

This mechanism targets dormant cone photoreceptors, which have lost their light-converting ability but remain structurally intact. By reintroducing functional GIRK channels, SPVN20 aims to reestablish a natural physiological pathway of vision, enabling these dormant cones to regain their ability to convert light into electrical signals that the brain interprets as vision. The therapy is also designed to potentially restore aspects of color vision.

Importantly, this approach focuses on reactivating existing retinal cells rather than replacing them, a strategy that aligns with the company’s commitment to preserving and restoring native retinal function.

Clinical Expansion and Scientific Foundation

The trial began in Belgium, with plans to expand recruitment to France and Ireland. According to SparingVision, the Clinical Trial Application (CTA) for NYRVANA was supported by a comprehensive nonclinical data package, which demonstrated SPVN20-mediated light-evoked responses and functional rescue in cone photoreceptors across multiple in vitro, ex vivo, and in vivo models.

Executive Commentary

Stéphane Boissel, CEO of SparingVision, emphasized the broader significance of the trial launch:

“The initiation of NYRVANA represents a pivotal milestone for SparingVision and validates the therapeutic potential of our gene-agnostic gene therapy portfolio, offering a comprehensive approach to treat a variety of retinal diseases at different stages. With two clinical programs now advancing in parallel, we are moving closer to our mission of transforming outcomes for patients with blinding retinal diseases.”

Kali Stasi, Chief Medical Officer at SparingVision, elaborated on SPVN20’s mechanism of action:

“With SPVN20, we are taking this progress forward by reactivating dormant cones—the dedicated photoreceptor cells of the retinal circuit located at the start of the visual transmission pathway, which utilize the naturally occurring photosensitive protein opsin. This approach maximizes the chances of restoring central visual function that closely mirrors natural cone-mediated vision through a more physiological mechanism, improving the lives of these patients with no current treatment available.”

Looking Ahead

SparingVision also announced plans to explore the therapeutic synergy between SPVN20 and SPVN06, the company’s two lead assets, as a combined treatment under development named SPVN30. This combination product aims to address a broader population of RP patients, leveraging complementary mechanisms to expand clinical impact.