New clinical site added and early safety signals observed in trial for treatment of ocular disease caused by oxidative stress
First cohort is expected to achieve full enrollment by third quarter 2023
FORT WORTH, TX – July 11, 2023 - Nacuity Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing treatments for retinitis pigmentosa, cataracts and other ocular diseases caused by oxidative stress, today announced that a clinical trial site has been added to its Phase 1/2 clinical trial evaluating NPI-002, a proprietary antioxidant molecule delivered via a sustained release intravitreal implant, for the delay of cataract progression in patients undergoing vitrectomy.
The first part of the Phase 1/2 randomized, controlled, masked clinical trial assessing the safety and efficacy of NPI-002 in delaying cataract progression in patients undergoing vitrectomy is currently underway at The Royal Adelaide Hosipital (RAH) in Adelaide, South Australia, with four participants enrolled and three patients who have been screened awaiting vitrectomy. Promising safety signals have been observed in the initial subjects. An additional enrolling clinical site - PersonalEYES - has been recently activated.
“While cataracts are the leading cause of blindness worldwide, patients remain underserved as no approved drug therapies to slow progression currently exist, and the only treatment option is surgery,” said Robert Casson, MBBS (Hons), DPhil, principal investigator of the trial and Professor, Royal Adelaide Hospital. “Oxidative stress plays a critical role in the onset and progression of cataracts and may be reduced using NPI-002, a differentiated antioxidant therapy.”
The first cohort is expected to achieve full enrollment by the third quarter of 2023, with full enrollment of 30 patients across all sites targeted by the end of 2023. Clinical proof of concept data is expected by mid 2024.
“Cataracts adversely affect a person’s quality of life, causing blurry vision, glare and faded colors. Unfortunately, patients over the age of 50 who undergo vitrectomy surgery experience accelerated cataract progression,” said Nancy Holekamp, M.D., Director of Retina Services at Pepose Vision Institute in Chesterfield, MO, and member of Nacuity’s Scientific Advisory Board. “With this in mind, we designed the Phase 1/2 trial of NPI-002 to confirm and build upon the encouraging preclinical data and to ultimately offer patients a novel, safe and efficacious treatment option to slow the progression of cataracts.”
Patients undergoing vitrectomy are highly likely to develop significant cataracts after their surgery and the majority of them require cataract surgery within a year of the vitrectomy. Delaying that subsequent surgery can improve surgical outcomes and alleviate the stress of having two ocular surgeries in a short period of time.
“With two of our lead candidates advancing through clinical proof-of-concept trials, this is a pivotal time of progress and growth for Nacuity,” said Halden Conner, Chairman, CEO, and Co-Founder of Nacuity Pharmaceuticals. “Our clinical programs are focused on treating retinitis pigmentosa and other eye diseases in which oxidative stress plays a significant role, including cataracts. We are encouraged by the early safety signals seen in this first cohort of our NP-2 trial and look forward to expanding the trial with the addition of a new site and reporting proof-of-concept data in 2024.”
For more information about the Phase 1/2 clinical trial of NPI-002, please visit clinicaltrials.gov (Identifier: NCT05026632).
NPI-002 is a novel, differentiated, slow-release, small molecule being developed to slow cataract progression. For the treatment of cataract, a sterile intravitreal implant containing NPI-002 has been developed, along with a precision delivery system. In vitro and in vivo studies showed vitreal elution over time and revealed no cytotoxicity with NPI-002. In ex-vivo rat and porcine lenses, NPI-002 inhibited oxidative-induced cataracts. NPI-002 is currently being evaluated in a Phase 1/2 proof-of-concept clinical trial in Australia (NCT05026632).
About Nacuity Pharmaceuticals
Nacuity Pharmaceuticals is a clinical-stage leader in innovative treatments for oxidative stress. The company’s powerful, targeted therapies aim to stop 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 in retinitis pigmentosa, cataracts and cystinosis with the potential to be first-of-a-kind therapies and gateways to wider applications. Based in Fort Worth, TX, the company has extensive managerial and scientific domain expertise as well as backing from Foundation Fighting Blindness (https://www.fightingblindness.org/) and its venture arm RD Fund (https://www.retinaldegenerationfund.org). For more information, please visit www.nacuity.com.