Just over 1 year since we last reported a clinical update on VRDN-001, Viridian Therapeutics, Inc.’s lead investigational candidate for chronic thyroid eye disease (TED), the company announced patient enrollment has concluded for the phase 3 THRIVE-2 trial.
Let’s start with Viridian.
The Massachusetts-based biopharmaceutical company is using antibody and protein engineering to develop:
- Differentiated candidates for autoimmune diseases (such as TED)
- Anti-neonatal Fc receptor (FcRn)-targeting candidates (for other autoimmune disorders)
And zeroing in on TED…
Two candidates are currently undergoing clinical research:
- VRDN-001 (administered via intravenous [IV] infusion)
- Dosing: Five, 30-minute infusions
- Administered 3 weeks apart
- Dosing: Five, 30-minute infusions
- VRDN-003 (self-administered via subcutaneous [SC] injection)
- Dosing: Every 4 or 8 weeks
- Clinical update: Two phase 3 trials (REVEAL-1 and REVEAL-2) are expected to be initiated in August 2024.
- Dosing: Every 4 or 8 weeks
And what are they?
Anti-insulin-like factor-1 receptor (IGF-IR) monoclonal antibodies that block cell surface receptor activity.
- Their potential: For reducing tissue swelling and inflammation associated with TED.
- Note: Both transmembrane receptors also play key roles in development, metabolism, and immune regulations—and are known as clinically and validated targets for TED treatment
Talk about VRDN-001’s clinical status.
As we reported in July 2023, the company released preliminary positive data from a placebo-controlled, proof-of-concept phase 1/2 study evaluating the potential for VRDN-001 to deliver rapid improvement of symptoms among chronic TED patients—including proptosis.
The findings: VRDN-001 was found to be generally well-tolerated, demonstrating a favorable safety and tolerability profile consistent with previously-reported 6-week data for patients with active TED.
Any other trials to know about?
Yes! The first phase 3 trial VRDN-001 is being clinical studied in: THRIVE (NCT05176639).
A topline data readout from that multiple-ascending dose (MAD) study is currently on track for September 2024, Viridian reported.
Now give me the rundown on THRIVE-2.
The randomized, double-masked, placebo-controlled safety, tolerability, and efficacy study (NCT06021054) has enrolled a total of 188 participants (exceeding the initial 159-patient target due to high demand).
Participant criteria: Aged 18+, diagnosed with chronic TED, with a clinical activity score (CAS) of (0-7) item scale for the study eye
The study setup: A five-dose treatment arm of VRN-001 10 mg/kg will be compared to a placebo, with each dose administered 3 weeks apart
And what’s being measured?
The primary outcome measure is proptosis responder rate in the study eye, as measured by a reduction of proptosis of ≥2 mm from baseline at 3 weeks following the fifth dose infusion.
Measured at Week 15, secondary outcome measures include:
- Change from baseline in proptosis in the study eye
- Clinical activity responder rate in the study
- Change from baseline in CAS in the study eye
- Overall Response Rate (ORR) in the study eye
- Diplopia resolution rate
So when might data be expected from this study?
Per Clinical Trials, the THRIVE-2 study is expected to conclude in September 2025.
In the meantime, however, keep an eye out for that topline data from the original THRIVE study in September 2024.