Beacon Therapeutics Announces Positive 3-Month Data from Phase 2 DAWN Trial of laru-zova (AGTC-501) in Patients with X-Linked Retinitis Pigmentosa (XLRP)

• To date, laru-zova has been well-tolerated by all participants in the Phase 2 DAWN study.
• Data show promising early improvements in low luminance visual acuity (LLVA), a critical measure of visual function.
• Data build confidence in laru-zova as a potential treatment for patients with XLRP.
• Pivotal Phase 2/3 VISTA trial for laru-zova in XLRP is currently enrolling.

Excerpt from the Press Release:

LONDON and CAMBRIDGE, Mass., Dec. 6, 2024 /PRNewswire/ — Beacon Therapeutics Holdings Limited (‘Beacon Therapeutics’ or ‘the Company’), a leading ophthalmic gene therapy company with a purpose to save and restore the vision of patients with blinding retinal diseases, today announced the presentation of 3-month interim safety and efficacy results of the Phase 2 DAWN trial in patients with XLRP at the FLORetina-ICOOR Meeting 2024 in Florence, Italy.

Key presentation highlights:

• The three-month data show that laru-zova has been well-tolerated by all participants.
• No study agent-related treatment emergent adverse events (TEAEs) were reported, including no ocular inflammatory adverse events.
• Data also show promising early improvements in LLVA, a critical measure of visual function.
• The benefit-risk profile supports on-going clinical development for the treatment of patients with XLRP caused by RPGR mutations.

DAWN is a non-randomized, open-label study of laru-zova in participants with XLRP who have previously been treated with a full-length AAV-vector based gene therapy targeting the RPGR protein. The purpose of DAWN is to assess two different doses of laru-zova for efficacy, safety and tolerability in the untreated eye of participants who previously received gene therapy for XLRP.

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