Strong enrollment in Phase 3 trial demonstrates continued execution
Interim analysis expected in 2Q 2023
Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis, commented: "We are very pleased with the pace of enrollment in our Phase 3 study, which is designed to assess the safety and efficacy of buntanetap in early-stage Parkinson's patients. Buntanetap is a highly differentiated and potentially ground-breaking therapy that has been designed to inhibit the production of multiple neurotoxic proteins which are associated with several neurodegenerative conditions, including Parkinson's disease and Alzheimer's disease. We look forward to providing an interim data analysis from the study in the second quarter of 2023, which will enable us to optimize our patient enrollment for the study."
Based on the current enrollment, the Company anticipates having a sufficient number of patients who have received two months of therapy to conduct an interim analysis in the second quarter of 2023. The purpose of the interim analysis is to determine if the Company's original estimates for patient enrollment in the Phase 3 trial (150 patients per arm) will be sufficient to observe a statistically significant treatment effect in both scales between the active arms and the control arm of the study after six months of treatment.
More specifically, the interim analysis could confirm that 150 patients is the optimal number, or it could inform that less patients are needed (the efficacy is better than expected) or that more patients are needed (the efficacy is less than expected). The boundaries of the extent to which we will decrease or increase the number of patients is +/- 25% or between 112 and 200 patients per arm.
The ongoing Phase 3 trial is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap in patients with early-stage Parkinson's disease. Patients are being treated with 10mg buntanetap, 20mg buntanetap or placebo, on top of their standard of care, for six months. Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and III will be used as primary endpoints, while total MDS-UPDRS and Participant Global Impression of Change will be secondary endpoints. In addition, Wechsler Adult Intelligence Scale, plasma biomarkers and Mini-Mental State Examination will be evaluated as exploratory endpoints.
The Company's Phase 3 trial in PD builds upon earlier, proof-of-concept data from a Phase 2a study which demonstrated that patients treated with buntanetap showed statistically significant improvements in both motor function and coding speed, as measured by MDS-UPRDS Part III and WAIS Coding scores.1 Additionally, no clinically significant adverse events were observed in the Phase 2a study and its pharmacokinetics were found to be in line with levels measured earlier in humans.
1 Fang et al: Buntanetap Proves Promising in Both Alzheimer's and Parkinson's Patients; J Prevention Alzheimer Disease 10-2022
Buntanetap (previously known as ANVS401 or Posiphen) is an oral translational inhibitor of neurotoxic aggregating proteins (TINAPs), which mode of action leads to a lower level of neurotoxic proteins and consequently less toxicity in the brain. In a Phase 2a clinical trial in Alzheimer's disease (AD) and Parkinson's disease (PD) patients, buntanetap was shown to be well-tolerated and safe, and its pharmacokinetics were found to be in line with levels measured earlier in humans, meeting both the primary and secondary endpoints. Additionally, exploratory endpoints were also met, as treatment with buntanetap resulted in statistically significant improvement in motor function in PD patients and cognition in AD patients. Presently buntanetap is being studied in a Phase 3 early PD study and in a Phase 2/3 study in AD patients.
About Annovis Bio, Inc.
Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. (Annovis) is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's disease (AD), Parkinson's disease (PD), and other chronic neurodegenerative diseases. We believe that we are the only company developing a drug for AD and PD that inhibits more than one neurotoxic protein and, thereby, improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. Annovis conducted two Phase 2 studies: one in AD patients and one in both AD and PD patients. In the AD/PD study buntanetap showed improvements in cognition and memory in AD as well as body and brain function in PD patients.
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