Aviceda Therapeutics has dosed the first patient in a phase 2 trial assessing its lead intravitreal ocular asset AVD-104 for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Give me a rundown on AVD-104.
AVD-104 is glyco-immune therapeutic (GIT) and sialic-acid coated nanoparticle that targets a specific area of the innate immune response relating to AMD in order to potentially prevent dysregulated activity and activate cellular machinery within retinal tissue back into a reparative state.
Unlike previous treatments that shut down humoral components of the innate immune response in order to target AMD, AVD-104 focuses on the cellular and humoral aspects of inflammatory processes within AMD in an effective and well-tolerated delivery system.
Wait .. didn’t we just hear about this?
Within the last 3 months, yes! In April 2023, the FDA cleared Aviceda’s investigational new drug (IND) application for AVD-104, which paved the way for the company to move forward with this phase 2 trial.
Of note, the company also submitted (in March 2023) a Fast Track Designation application to the FDA for its lead asset, per the FDA’s request.
Any prior data on it?
Yes, there is … but only on non-human primates and rabbits.
Dose-ranging studies reported positive data (with the potential for 4 to 6-month dosing).
Now tell me about this phase 2 study.
The phase 2 SIGLEC trial (NCT05839041) has enrolled 210 patients (ages 55 and older) and is divided into two parts:
- Part 1 → Open-label, multicenter, dose escalation (experimental)
- Part 2 → Double-masked, randomized, multicenter (active comparator)
Let’s talk about this first part.
Part 1 includes (potentially, according to Clinical Trials) 24 participants receiving a single intravitreal injection of AVD-104 at one of three escalating doses; all patients will be followed for 3 months for safety observation.
Further, participants will have the opportunity to receive high-dose monthly injections of AVD-104 (and be followed for safety), but only once 50% of patients in part 2 of the study reach the 6-month mark.
Speaking of part 2 …
Part 2 includes three groups: Low-dose AVD-104 (n = 70), high-dose AVD-104 (n = 70), and sham injections (n = 70).
- High dose → Monthly injections for the first 12 months; for months 13-24, 50% of the group will be randomized to every-other-month injections, while 50% will continue monthly injections.
- Low dose → Monthly injections for all 24 months.
- Sham → Monthly injections for all 24 months.
What’s being measured?
Two primary outcomes:
- Part 1 → Number of patients who experience a dose-limiting toxicity corresponding to a category of 3 or greater (on the National Cancer Institute Common Terminology Criteria for Adverse Events) for a 3-month period.
- Part 2 → Rate of change in GA area at month 12, as measured by fundus autofluorescence (FAF).
- Secondary outcome: change from baseline in best-corrected visual acuity (BCVA) at month 12, as assessed with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity.
Anything to know about this first patient dosing?
According to Aviceda, the patient was dosed by Ashkan M. Abbey, MD, of the Texas Retina Associates in Dallas, Texas.
What’s next?
Per Clinical Trials, the phase 2 study is slated for completion by July 2026. Stay tuned for data updates in the meantime!
Significance?
AVD-104 has the potential to be the first therapy that could address the underlying causes of AMD.