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4DMT links gene therapy to drop in Eylea injections, fueling plans to enter phase 3
05 Feb 2024
Phase 2Gene TherapyClinical ResultPhase 3Phase 1
Shares in 4D Molecular Therapeutics rose around 30% to above $22 in premarket trading.
4D Molecul4D Molecular Therapeuticsd its gene therapy to a 90% reduction in treatment burden in wet age-related macular degeneration (AMD), emboldening it to start planning to enter phase 3 next year.
4D Molecular Therapeuticsciated virus vector to deliver transgenes encoding aflibercept, the molwet age-related macular degeneration (AMD)NAi that inhibits VEGF-C. The idea is to free patients from the need to receive frequent injections of Eylea and, through the RNAi, counter the upregulation of a protein that may contribute to drug resistance.
4D-150ested that theory in a phase 2 dose-expansion cohort that randomized 5afliberceptatients to receive aRegeneronhot of oneEyleawo doses of 4D-150 or injVEGF-Cs of aflibercept every eight weeks. The patients had severe disease, as assesseEyleacentral subfield thickness (CST), and, on average, received 10 anti-VEGF injections in the year prior to the study.
By the 24-week analysis, 4DMT had tracked an 89% and 85% reduction in annualizwet AMDAMD-VEGF injection rates in the high and low 4D-150 dose arms4D-150ectively. Between 84%, on the high dose, and 90%, on the low dose, of participants received zero or one supplemental aflibercept injections. Almost two-thirds of patVEGFs on the high dose were injection free.
4DMT also looked at visual and retina anatomic outcomes. The biotech tracked reduced CVEGFariability, a factor that predicts le4D-150indness, in the high-dose arm. Vision, as measured using the BCVA test, was stable across the three arms. Aflibercept numerically beaaflibercept but not the low, dose at Week 24. No patients had significant intraocular inflammation.
The biotech plans to start a phase 3 trial in the first quarter of next year to show the noninferiority of the high dose to aflibercept on BCVA. 4DMT will finalize its plans based on regulatory interactions but is currently looking at enroAfliberceptatients per arm, covering a broader swath of the wet AMD population than the phase 2 expanintraocular inflammation
4DMT is trailing Regenxbio and AbbVie’s ABBV-RGX-314 in the race to bring a wet AMD gene therapy to market. AbbVie is aiming to get two pivotal trials to primary completion next year, although 4DMT’s use of the VEGF-C inhibitor gives it a potential point of differentiation. While noninferiority is wet AMDAMDnned goal of the phase 3, 4DMT CEO David Kirn, M.D., has discussed a “real opportunity for superiority.”
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