Policy & Regulation
Annovis Bio reveals patient enrolment update for Phase three buntanetap study
26 January 2023 -

Annovis Bio, Inc. (NYSE: ANVS), a US-based clinical-stage drug platform company addressing neurodegenerative diseases, announced on Wednesday a patient enrolment update for the firm's ongoing Phase three study of buntanetap intended to treat Parkinson's disease (PD).

The firm expects to have a sufficient number of patients who have received two months of therapy to carry out an interim analysis in the second quarter of 2023 based on the present enrolment. The aim of the interim analysis is to determine if the firm's original estimates for patient enrolment in the Phase three trial, which includes 150 patients per arm, will be sufficient to observe a statistically significant treatment impact in both scales between the active arms and the control arm of the study after six months of treatment.

The ongoing Phase three trial, a randomised, double-blind, placebo-controlled trial, is assessing the efficacy, safety, and tolerability of buntanetap in subjects with early-stage Parkinson's disease. Patients are being administered with 10mg buntanetap, 20mg buntanetap or placebo, in addition to their standard of care, for six months. The primary endpoint will be Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and III, and the secondary endpoints will be total MDS-UPDRS and Participant Global Impression of Change. The exploratory endpoints will be assessed through the Wechsler Adult Intelligence Scale, plasma biomarkers and Mini-Mental State Examination.