A clinical site has been added to Nacuity Pharmaceuticals’ phase 1/2 clinical trial assessing NPI-002 for the delay of cataract progression in patients undergoing vitrectomy, the company announced.
Let’s start with NPI-002.
NPI-002 is a proprietary, small-molecule antioxidant delivered via a sterile, sustained-release intravitreal implant to slow cataract progression.
The investigational asset is an analog to Nacuity’s lead candidate, NPI-001—an oral dosage treatment for retinitis pigmentosa (RP) in Usher syndrome—currently being assessed in the SLO-RP phase 1/2 clinical trial (click here for details).
Gotcha. Is there any clinical data on it yet?
Per Nacuity, NPI-002 has demonstrated activity against cataracts —peroxide- and glucose oxidase-induced, specifically—in ex-vivo isolated rat and pig lenses.
Gotcha. So tell me about this study.
For the first part of the randomized, controlled, masked, interventional proof-of-concept phase 1/2 clinical trial (NCT05026632), so far a total of four patients have been enrolled and three patients have been screened and awaiting vitrectomy.
How were patients selected?
Per Clinical Trials, inclusion criteria included patients (age 18+) and:
- Indicated for vitrectomy
- With a natural lens in place at time of vitrectomy
- With some cataract present, as assessed pre-op
How is NPI-002 being administered?
Patients are receiving either a single NPI-002 implant inserted during vitrectomy, two NPI-002 implants inserted during vitrectomy, or no implant inserted during vitrectomy.
What’s being measured?
The lone outcome measure is lens densitometry, as measured by change from baseline at 6 months .
So where is this being conducted?
Since its launch in January 2022, the study has been conducted at The Royal Adelaide Hospital (RAH) in Adelaide, South Australia.
A new enrolling site has also been activated recently: PersonalEYES.
And what’s next?
Per Nacuity, the first cohort is expected to complete enrollment (n = 30) by Q3 2023, with clinical proof-of-concept-data anticipated by mid-2024 (April 2024, according to Clinical Trials).