Nacuity Pharmaceuticals Announces First Patient Dosed in Global Confirmatory Phase 3 Trial of NPI-001 (N-acetylcysteine amide) Tablets for the Treatment of Retinitis Pigmentosa Associated with Usher Syndrome

SLO-RP Preserve trial sites actively enrolling

FORT WORTH, Texas, Oct. 28, 2026 (GLOBE NEWSWIRE) -- Nacuity Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing treatments for retinitis pigmentosa, cataracts and other diseases caused by oxidative stress, today announced that the first patient has been dosed in the global, confirmatory Phase 3 SLO-RP Preserve clinical trial of NPI-001 for the treatment of retinitis pigmentosa (RP) associated with Usher Syndrome. The Inherited Retinal Degeneration Clinic at the Retina Foundation of the Southwest in Dallas, TX, and other sites in the US and Australia are actively enrolling additional patients.

RP associated with Usher syndrome is a rare, progressive inherited retinal disease that leads to irreversible vision loss and currently has no approved therapies that slow photoreceptor degeneration. SLO-RP Preserve is designed to evaluate whether NPI-001 can slow disease progression by reducing photoreceptor loss.

“We are highly encouraged by the positive results achieved in our Phase 2 study, which reinforce our motivation and commitment to advancing this important clinical program,” said Jami Kern, MBA, Ph.D., Chief Clinical Officer at Nacuity. “Our team is working diligently to move the study forward as quickly as possible, while maintaining our commitment to rigorous science and patient safety.”

The 24-month, randomized, double-masked study (NCT07710196) will enroll up to 80 adult participants who will self-administer an NPI-001 or a placebo tablet twice a day orally and complete nine in-clinic visits over approximately two years.

“We’re excited that the first patient has been dosed in this important confirmatory study,” said Mark Pennesi, MD, Ph.D., Chief Medical Officer and Director of the Inherited Retinal Degeneration Center at the Retina Foundation and SLO-RP Preserve principal investigator. “Patients living with RP associated with Usher syndrome face progressive vision loss with limited treatment options. Building on the encouraging findings observed to date, we look forward to further evaluating the potential of NPI-001 to slow disease progression and preserve vision in this Phase 3 trial.”

NPI-001 is a proprietary, GMP-grade formulation of N-acetylcysteine amide (NACA) tablets being developed to address diseases driven by oxidative stress.

“Dosing the first patient in our first Phase 3 trial marks a significant milestone for Nacuity and, more importantly, for the Usher syndrome community,” said Halden Conner, Chairman, CEO and Co-Founder of Nacuity. “We look forward to advancing NPI-001 through this confirmatory study as we work toward delivering a potential disease-modifying therapy for patients with RP associated with Usher syndrome. We’re grateful for our continued collaboration with the Retina Foundation of the Southwest and to the investigators, patients and families making this study possible.”

The SLO-RP Preserve trial will enroll patients across multiple sites in the United States and Australia. To learn more, please visit preservevisionstudy.com.

About NPI-001

NPI-001 is a proprietary, GMP-grade formulation of N-acetylcysteine amide (NACA) tablets being developed to target oxidative stress associated with diseases such as retinitis pigmentosa. Preclinical studies indicate that NPI-001 boosts glutathione, the body’s most powerful endogenous antioxidant, to stop chemically aggressive oxygen molecules from damaging retinal cells. NPI-001 is a stable tablet dosage form, easy for patients to self-administer, with convenient packaging options, and well-established manufacturing processes. In addition to Fast Track designation, NPI-001 has also been granted Breakthrough Therapy and Orphan Drug designations for RP, which provides seven years of U.S. FDA regulatory exclusivity for the product upon regulatory approval. NPI-001 is currently being evaluated in a global, confirmatory Phase 3 trial called SLO-RP Preserve.

About Nacuity Pharmaceuticals, Inc.

Nacuity Pharmaceuticals is a clinical-stage leader in innovative treatments for oxidative stress. The company’s powerful, targeted therapies aim to attenuate oxidative tissue damage, a driver of blinding eye diseases and a broad spectrum of serious chronic conditions. Nacuity has three highly differentiated clinical programs ongoing for retinitis pigmentosa, cataract and cystinosis. Nacuity has operations in Fort Worth, TX, USA, and Australia, and extensive managerial and scientific domain expertise as well as backing from Foundation Fighting Blindness (https://www.fightingblindness.org) and its venture arm Gund Vision Fund (https://gundvisionfund.org/). For more information, please visit www.nacuity.com.

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Media Contact:
Gina Mangiaracina
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gmangiaracina@6degreespr.com