4D Molecular Therapeutics (NASDAQ:FDMT) stock is trading lower on Thursday after the company released interim follow-up data from the Phase 1/2 PRISM clinical trial and 4FRONT Phase 3 study design.
Robust and durable treatment burden reduction was observed in all PRISM populations studied with the planned Phase 3 dose of 3E10 vg/eye of 4D-150.
83% overall reduction in annualized injections, 52% received 0 or 1 injection, and 44% injection-free in Phase 1/2a Severe study compared to Phase 2b Broad study with observations of 89%, 80%, and 70% injection-free, respectively.
In Phase 2b, recently diagnosed patients, a 98% overall reduction in annualized injections, 100% received 0 or 1 injection, and 87% injection-free was observed.
In June, 4D Molecular Therapeutics unveiled interim 24-week data from the Population Extension cohort of its PRISM Phase 2 Clinical Trial.
The trial evaluates intravitreal 4D-150 in a broad wet AMD patient population.
Central Subfield Thickness (CST): sustained anatomic control with fewer fluctuations.
4D-150 continues to be well tolerated with a favorable safety profile
The rate of 4D-150 intraocular inflammation (IOI) is numerically similar to that reported for approved anti-VEGF agents.
- Wet AMD:2.8% (2 of 71) had 4D-150–related IOI at any time point, and two patients had transient 1+ vitreous cells
- 99% (70 of 71) completed steroid prophylaxis taper on schedule and 97% (69 of 71) remained off steroids completely.
- Diabetic Macular Edema (DME; SPECTRA trial): No patients treated at any dose (n=22) have experienced IOI events at any time.
In February this year, 4D Molecular Therapeutics released interim data from the Phase 2 PRISM clinical trial evaluating intravitreal 4D-150 in wet age-related macular degeneration (wet AMD) patients.
The company plans for a global 4FRONT Phase 3 development program comparing a single dose of 4D-150 3E10 vg/eye to on-label Regeneron Pharmaceuticals Inc.'s (NASDAQ: REGNP Eylea (aflibercept) 2mg Q8 weeks. The trial is expected to start in the first quarter of 2025, with around 500 participants.
Price Action: FDMT stock is down 18.80% at $13.66 at the last check on Thursday.
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