SparingVision Completes Dosing in Gene-Agnostic Therapy Trial for Retinitis Pigmentosa (RP)

SparingVision has completed patient dosing in its Phase I/II PRODYGY clinical trial evaluating SPVN06, an investigational gene therapy designed to preserve cone-mediated vision in people with retinitis pigmentosa (RP). All 27 patients who received SPVN06 continue to demonstrate a favorable safety profile, with initial efficacy data expected in 2027.

Unlike traditional gene therapies that target specific genetic mutations, SPVN06 could help RP patients at any stage at which cone photoreceptors remain functional, regardless of the gene variants causing their vision loss. The therapy works by protecting cone photoreceptors, the light-sensing cells responsible for central vision, visual acuity, and color perception.

"By sustaining the natural function of photoreceptors, SPVN06 has the unique potential to preserve visual acuity and color vision in degenerative retinal diseases such as RP, regardless of genetic mutation or cause of the disease," said Dr. Kali Stasi, Chief Medical Officer of SparingVision.

The PRODYGY trial enrolled 33 participants: 27 received SPVN06 at varying doses, and 6 were randomized to an untreated control group. The study is evaluating both safety and exploratory efficacy endpoints, including functional, anatomical, and quality-of-life outcomes.

SparingVision is employing advanced AI-powered machine learning tools alongside traditional statistical analyses to evaluate the trial data comprehensively. These analytical approaches will help identify efficacy signals and inform the design of a pivotal registration trial planned for 2027.

Beyond RP, SPVN06's cone-preserving mechanism could have applications in other retinal conditions where cone photoreceptor loss leads to blindness, including age-related macular degeneration (AMD) and other inherited retinal diseases.

SparingVision is supported through the venture arm of the Foundation, the RD Fund, which invests in emerging therapies, including clinical proof of concept trials. The Foundation also provided several years of research grant funding for the preclinical development of SPVN06.