4D Molecular Therapeutics (NASDAQ:FDMT) shares are trading higher after the company released interim data from the Phase 2 PRISM clinical trial evaluating intravitreal 4D-150 in wet age-related macular degeneration (wet AMD) patients.
Data presented at the Angiogenesis, Exudation, and Degeneration 2024 Conference consisted of 24-week landmark results from the PRISM clinical trial’s randomized Phase 2 Dose Expansion cohort.
A single intravitreal dose of 4D-150 demonstrated favorable safety results through the data cutoff date (all ophthalmic exams through up to 48 weeks of follow-up):
No significant intraocular inflammation
- High dose: None
- 97% (38 of 39 pts) completed the 20-week prophylactic topical corticosteroid taper on schedule
- Low dose: Single eye at week 16 had 1+ anterior mixed (pigmented & white blood) cells, resolved by next visit and completed prophylactic topical corticosteroid taper by week 26
- All patients are currently off steroids.
- No 4D–150–related serious adverse events (SAEs) or study eye SAEs, with no hypotony, endophthalmitis, retinal vasculitis, choroidal effusions, or retinal artery occlusions, were observed.
High dose 4D-150 resulted in an 89% reduction in the annualized anti-VEGF injection rate; 84% of patients received 0 or 1 injection, and 63% were injection-free through 24 weeks; visual acuity and central subfield thickness were both stable vs. Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) Eylea ( aflibercept).
4D-150 was well tolerated with a favorable safety profile when evaluated through up to 48 weeks of follow-up: no significant inflammation was observed (including no Grade ≥1+ inflammation in high-dose patients), and all patients remained off topical steroids.
The company plans to start the first Phase 3 study in the first quarter of 2025.
Safety results were maintained in all 15 patients treated to date (up to 104 weeks of follow-up) with no new inflammation or change in steroid status.
Price Action:Â FDMT shares are up 71.58% at $30.00 on the last check Monday.
Photo by Amanda Dalbjörn on Unsplash
