To recap, what we know from our findings to-date is that OCU400 has a favorable safety and tolerability profile in patients. Positive trends are observed in all set visual [Indiscernible] instability and improvement factors, which details that 83% of subjects demonstrated stabilization or improvement in the treated eye either on BCVA,LLVA or MLNT scores from baseline. 75% of subjects show stabilization or improvement in treated eyes and MLMT scores from baseline. 86% of RHO mutation subjects experienced either stabilization or improvement in MLMT scores from baseline, among which 29% demonstrated three lux luminescence level improvement, demonstrating the gene agnostic mechanism of action of OCU400. The RHO mutation affects more than 10,000 people in the U.S. alone.
Based on this data, we are highly enthusiastic about the future of OCU400 and the vision-saving potential it may provide to RP and LCA patients. The execution of critical elements of the OCU400 Phase 1/2 trial, including the completion of dosing of RP and LCA patients sets the stage for us to execute a Phase 3 clinical trial for both indications in 2024 upon FDA concurrence. OCU410, our modified gene therapy candidate for dry age-related macular degeneration, AMD, is a potential one-time curative therapy with a single subretinal injection that targets multiple pathways causing dry AMD, including lipid metabolism, inflammation, oxidative stress, and complement activation. Unlike other currently market products targeting a single pathway, complement activation.
We are currently enrolling patients in the Phase 1/2 OMPD study to assess the safety and efficacy of OCU410 for geographic atrophy secondary to dry AMD. Geographic atrophy, an advanced form of dry age-related macular degeneration, affects approximately 1 million people in the United States alone. From a competitive standpoint, we believe OCU410 is differentiated among other therapies available and in development for geographic atrophy and dry AMD by its frequency of administration, one-time versus multiple injections per year, reduced side effects from structural impact, strong safety profile, its mechanism for restoring homeostasis and preserving the conditions that promote self-help. The slide demonstrates how OCU410 utilizes an AAV delivery platform for the retinal delivery of RORA gene.
In preclinical studies, OCU410 demonstrated efficacy in regulating multiple pathways involved with the disease, including lipid metabolism, reducing drusen inflammation, regulation of inflammation, suppressing information, oxidative stress, improving cell survival, membrane attack complex — complement, restoring anti-complement protein. On this slide, we have captured a proposed program design for OCU410. In 63 adult subjects, 50 or older, with geographic atrophy, secondary to dry AMD, we will observe the treatment effect of our single unilateral subretinal injection OCU410, starting with safety and efficacy in patients. We’re employing a three-plus-three design with a low, medium, and high dose in addition to a dose expansion exercise using a one-to-one-to-one design, randomizing subjects to either two treatment groups or dose levels or one control group.
Using a similar approach, our orphan drug designated OCU410ST modifier gene therapy platform of Stargardt disease leverages nuclear hormone receptors to modulate cell activity and utilize this and AIV delivery platform for retinal delivery of the RAR-related orphan receptor A. OCU410 delivery and preclinical studies of Stargardt disease demonstrated a structural and functional improvement. In the OCU410ST Phase 1/2 trial, we intend to treat and investigate 42 subjects, 30 of which are adults, and 12 are children with Stargardt disease. The adult inclusion criteria look at adult patients between 18 to 65 and pediatrics between six to 17. We’re employing a three-plus-three design with a low, medium, and high dose cohort in addition to your dose expansion exercise using a one-to-one-to-one design, randomizing subjects to either two treatment groups per dose levels or one control group.
Our team’s diligent efforts resulted in NIAID selecting OCU400 for inclusion in a project next-gen Phase 1 clinical trial of our mucosal vaccine candidates for COVID-19 likely to be initiated in the first-half of 2024. From our own development efforts, we observed vaccine-induced high neutralizing and effector responses during preclinical studies on OCU500. We believe the inhaled route of administration has the potential to be the holy grail for broad and durable protection from severe diseases and can suppress the transmission rate. As a refresher, Project NextGen, a multi-government agency initiative overseen by NIAID, is a $5 billion multi-government agency initiative to develop the next generation of vaccines and therapeutics to combat the spread of COVID-19.
