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A Phase 1b/2a, Open-label, Dose Escalation Study to Evaluate the Safety and Clinical Activity of Intramuscular Doses of BB-301 Administered to Subjects With Oculopharyngeal Muscular Dystrophy With Dysphagia

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Trial Profile

A Phase 1b/2a, Open-label, Dose Escalation Study to Evaluate the Safety and Clinical Activity of Intramuscular Doses of BB-301 Administered to Subjects With Oculopharyngeal Muscular Dystrophy With Dysphagia

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Dec 2025

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At a glance

  • Drugs BB 301 (Primary)
  • Indications Oculopharyngeal muscular dystrophy
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Benitec Biopharma

Most Recent Events

  • 15 Nov 2025 According to a Benitec Biopharma media release, the company hosted a webcast to discuss the positive interim clinical study results from its Phase 1b/2a trial of BB-301 on Monday November 3, 2025
  • 03 Nov 2025 According to a Benitec Biopharma media release, the company will provide an update on the 6 treated patients from Cohort 1 of its Phase 1b/2a Clinical Study in a webcast to be held on November 3, 2025 at 8:00 am EST.
  • 03 Nov 2025 According to a Benitec Biopharma media release, based on positive interim results from cohort 1, the U.S. FDA has granted Fast Track designation for the treatment of OPMD with dysphagia.

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