Annovis Bio has received approval to open additional European clinical trial sites for the Phase III study of buntanetap to treat Parkinson’s disease (PD).
The approval will add 48 additional clinical trial sites in five European Union (EU) countries including Germany, Spain, Poland, Italy, and Hungary.
With 50 clinical trial sites open in the US, the company is currently enrolling participants for the Phase III trial.
The double-blind, randomised, placebo-controlled trial has been designed for assessing the tolerability, safety, and efficacy of buntanetap in early-stage PD patients.
In the trial, patients are being treated with 10mg and 20mg of buntanetap or a placebo, in addition to their standard of care, for six months.
The sites will enrol participants in the initial cohort of early PD patients.
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An interim analysis is expected in the second quarter of this year, if there is a sufficient number of participants who have received two months of therapy.
Annovis Bio founder, president, and CEO Maria Maccecchini said: “We are pleased to significantly expand our geographic reach with the addition of these EU sites that gives us the ability to efficiently enrol European patients in our study.”
The company stated that the interim analysis will be used for determining whether its original estimates for patient enrolment in the trial, of 150 patients in each arm, will be sufficient for observing a statistically significant treatment effect in the active arms and the control arm following six months of treatment.
It noted that the Phase III trial builds on the previous, proof-of-concept data obtained from the Phase IIa trial.
In the Phase IIa trial, buntanetap-treated patients demonstrated statistically significant improvements in motor function and coding speed, as measured by MDS-UPRDS Part III and WAIS Coding scores.