Benitec Biopharma has enrolled the first oculopharyngeal muscular dystrophy (OPMD) patient in the OPMD natural history (NH) phase of the BB-301 clinical development programme.
The study is the six-month, pre-treatment observation period for each OPMD patient before giving BB-301 to treat OPMD-related dysphagia.
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The participants will be eligible for BB-301 Phase Ib/IIa treatment study enrolment after completing radiographic and clinical evaluations for six months for the NH Study.
Benitec stated that the OPMD NH study will enable the characterisation of OPMD patient disposition at baseline.
It will also evaluate subsequent rates of dysphagia progression by using quantitative radiographic measures including total pharyngeal residue, the dynamic imaging grade of swallowing toxicity scale (DIGEST), pharyngeal area at maximum constriction (PhAMPC), vallecular residue, and other pharyngeal residue.
It will also measure the Pharyngeal Construction Ratio (PCR), and normalised residue ratio scale (NRRSv, NRRSp).
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By GlobalDataBenitec Biopharma executive chairman and CEO Jerel Banks said: “Following the initiation of OPMD patient screening at the lead clinical site in the United States in the fourth quarter of 2022, the Principal Investigator of the OPMD NH Study reported high enrollment interest from potential study subjects.
“The formal initiation of the OPMD NH Study represents a major milestone for Benitec, and the enrollment of the first patient supports our central clinical development goal of administering the first dose of BB-301 in 2023.
“We continue to work with regulators globally to open additional sites in geographies outside of the United States.”
The company stated that the NH Study will also include clinical measures of oropharyngeal dysphagia, global swallowing capacity, and two distinct patient-reported outcome instruments that target the evaluation of oropharyngeal dysphagia.
