Detailed Phase II results are expected in the first half of 2024. Credit: Net Vector / Shutterstock.

4D Molecular Therapeutics (4DMT) has provided a timeline for the development of 4D-150 to treat wet age-related macular degeneration (wet AMD).

4D-150 is an intravitreal vector-based therapy developed using the therapeutic vector evolution platform as an adeno-associated virus vector to deliver an anti-VEGF transgene that expresses both aflibercept and a VEGF-C inhibitory RNAi, to treat wet AMD.

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According to GlobalData, the current market for wet AMD treatment is dominated by anti-VEGF therapies Roche and Novartis’ Lucentis (ranibizumab), Roche and Chugai’s Avastin (bevacizumab), and Regeneron and Bayer’s Eylea (aflibercept).

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The multicentre, randomised Phase I/II PRISM trial (NCT05197270) has completed enrolment for the open-label Phase II dose expansion stage. The trial will assess the safety and efficacy of 4D-150 at two dose levels in 50 patients.

The interim reported data demonstrated no treatment-related adverse reactions. Detailed results are expected in the first half of 2024, as per the company’s press release.

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4DMT plans to start Phase III trial discussions with the US’ FDA in Q4 2023, with a trial update planned for Q1 2024.

4DMT CEO David Kirn also provided updates on their other pipeline candidates, stating: “We believe that 4D-150’s differentiated profile has the potential to also drive rapid enrolment in our diabetic macular oedema (DME) programme, and we expect to enrol our first patient in the Phase II SPECTRA trial in Q3 2023.

“We remain committed to the advancement of our large market ophthalmology product candidates, including 4D-150 for wet AMD and DME, as well as 4D-175 for geographic atrophy.”

There have been an increasing number of trials for wet AMD, with GlobalData forecasting the AMD market to expand to $19.8bn in 2028.

The other Phase I/II pipeline drugs include a single-dose aerosol drug (4D-710) for cystic fibrosis, a gene vector (4D-110) for choroideremia, gene therapy (4D-125) for X-linked retinitis pigmentosa. Along with 4D-310, gene therapy, for the treatment of classic (severe) Fabry disease cardiomyopathy, that has received a Fast Track Designation from the US FDA in 2020.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva. 

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