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A Phase 1/2, First-in-Human, Open-label, Assessor-Masked, Randomized, Controlled, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Subretinal Injection of SB-007 in Subjects With Stargardt Disease (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ATP Binding Cassette Subfamily A Member 4 (ABCA4) Gene

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Trial Profile

A Phase 1/2, First-in-Human, Open-label, Assessor-Masked, Randomized, Controlled, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Subretinal Injection of SB-007 in Subjects With Stargardt Disease (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ATP Binding Cassette Subfamily A Member 4 (ABCA4) Gene

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 Jan 2026

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At a glance

  • Drugs SB 007 (Primary)
  • Indications Stargardt disease
  • Focus Adverse reactions; First in man
  • Acronyms ASTRA
  • Sponsors Splice Bio

Most Recent Events

  • 13 Jan 2026 According to a Splice Bio media release, company has dosed first patient in the part B dose-expansion portion (treated at Oxford University Hospitals NHS Foundation Trust in Oxford, England) of phase 1/2 ASTRA clinical trial, evaluating SB-007 for the treatment of Stargardt disease caused by ABCA4 mutations.
  • 11 Jun 2025 According to Splice Bio media release, company announced the close of a $135 million Series B financing co-led by new investors EQT Life Sciences and Sanofi Ventures, with participation from Roche Venture Fund, as well as all existing investors. The funding will be used to advance interventional Phase 1/2 ASTRA study.
  • 19 Mar 2025 Status changed from planning to recruiting, according to SpliceBio media release.

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