Benitec Biopharma ((BNTC)) announced an update on their ongoing clinical study.
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Benitec Biopharma is conducting a study titled ‘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.’ The study aims to assess the safety, optimal dosage, and effectiveness of BB-301 in improving dysphagia symptoms in patients with Oculopharyngeal Muscular Dystrophy (OPMD).
The intervention being tested is BB-301, a genetic treatment delivered via intramuscular injections into specific throat muscles. It is designed to address the genetic cause of OPMD by delivering a gene of interest that produces a beneficial protein and short hairpin RNAs targeting the disease-causing mutant gene.
This interventional study follows a single-group model with no masking, focusing on treatment as its primary purpose. It involves dose escalation and expansion phases, enrolling up to 30 subjects to determine the best dose and evaluate clinical activity.
The study began on December 15, 2023, with the primary completion and estimated completion dates yet to be announced. The latest update was submitted on February 3, 2025, indicating ongoing recruitment.
The study’s progress could influence Benitec Biopharma’s stock performance, as positive outcomes might boost investor confidence and market position. The gene therapy market is competitive, with advancements potentially impacting industry dynamics.
The study is ongoing, with further details available on the ClinicalTrials portal.