4D Molecular Therapeutics completes enrollment in expansion stage of phase 2 wet AMD trial
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Key takeaways:
- 4D Molecular Therapeutics completed enrollment in the expansion stage of the PRISM trial.
- There have been no reports of significant safety events or inflammation with 4D-150.
4D Molecular Therapeutics completed enrollment in the phase 2 dose expansion stage of the PRISM clinical trial investigating 4D-150 for wet age-related macular degeneration, according to a press release.
“We believe, if approved, 4D-150’s differentiated clinical profile has the potential to greatly reduce the high treatment burden of current standard-of-care anti-VEGF therapies in wet AMD. This standard of care includes frequent injections, as often as monthly for certain patients,” David Kirn, MD, co-founder and CEO of 4DMT, told Healio. “4D-150 has the potential to meet that need with a single injection, which could significantly decrease or even eliminate the need for ongoing injections for controlling the disease.”
The expansion stage is investigating the safety and efficacy of 4D-150 in 50 participants with wet AMD randomly assigned 2:2:1 to 3E10 vg/eye of 4D-150, 1E10 vg/eye of 4D-150 or aflibercept.
To date, there have been no reports of treatment-emergent inflammatory cells of grade 1 or higher or deviations from the 20-week protocol-specified corticosteroid eye drop taper. In addition, hypotony, vasculitis and treatment-related serious adverse events have not been reported.
“We are working relentlessly with the FDA and investigators to bring this potentially transformative therapy to the market as quickly as possible, with initial discussions with the FDA on phase 3 pivotal trial design for 4D-150 for patients with wet AMD in Q4 2023, and we expect to provide an update on pivotal trial plans in Q1 2024,” Kirn told Healio.
Editor’s note: This article was updated on July 18, 2023, to add comments from David Kirn, MD.
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