Allegro Ophthalmics, LLC, has received approval from the FDA, under a special protocol assessment (SPA), for the design of a phase 2b/3 clinical trial of its first-in-class drug risuteganib (Luminate; ALG-1001) for the treatment of intermediate, non-exudative age-related macular degeneration (dry AMD).
Give me a refresh on risuteganib.
Risuteganib is an integrin-regulating therapy formulated to regulate and reduce mitochondrial dysfunction involved in intermediate dry AMD.
By targeting multiple pathways, the molecule aims to reduce the burden of oxidative stress and potentially restore retinal homeostasis.
What does this agreement mean for Allegro?
The assessment stipulates that the FDA must agree to the crucial elements of the overall design protocol—which includes entry criteria, dose selection, endpoints, and planned analyses—are appropriate and acceptable for a study to support a marketing application in the future.
What is the trial’s design based on?
The trial’s design is modeled off of the company’s completed U.S. phase 2a study (NCT03626636), which was a prospective, randomized, double-masked, placebo-controlled, multicenter trial that assessed the safety and efficacy of 1.0 mg risuteganib vs sham intravitreally injected in intermediate dry AMD patients.
What were the outcomes in that study?
Risuteganib was determined to be safe and had no reported drug-related serious adverse events.
The study met its primary endpoint: 48% of risuteganib-treated patients (Week 28) and 7% of sham-treated patients (Week 12) gaining ≥ 8 letters from baseline (p=0.013)
Tell me about this phase 2b/3 trial now.
The study is expected to evaluate risuteganib efficacy (52 weeks) and safety (through 96 weeks), with patients receiving 5 intravitreal injections 12 weeks apart followed by continued treatment throughout the study’s follow-up safety part.
What else will it be assessing?
The primary endpoint will be the improvement in both patient groups’ best-corrected visual acuity (BCVA) at 52 weeks.
To predict BCVA response to treatment, investigators will use threshold optical coherence tomography (OCT) screening to assist in predicting study outcomes and identifying which patients could potentially benefit the most from treatment.
What’s next?
Now we wait! Stay tuned for updates from Allegro regarding the potential initiation of the phase 2b/3 trial in the near future.