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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: 22 Sep 2026

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At a glance

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

Most Recent Events

  • 15 Sep 2026 According to a Benitec Biopharma media release, all six Cohort 1 (low dose BB-301) patients have completed the full 12-month post-treatment follow-up period, and Cohort 2 (high dose BB-301) is fully enrolled with all three patients having been safely treated.
  • 15 Sep 2026 According to a Benitec Biopharma media release, interim clinical results from this trial have been accepted for late-breaking presentation at the Annual Congress of the European Society of Gene and Cell Therapy (ESGCT) in Hamburg, Germany taking place on October 27-30, 2026
  • 14 May 2026 According to a Benitec Biopharma media release, key interim clinical study results were presented at the 2026 MDA Clinical & Scientific Conference.

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