Annovis Bio, Inc. (Annovis) is a late-stage drug platform company developing innovative
therapies for neurodegenerative disorders such as Alzheimer’s disease (AD) and
Parkinson’s disease (PD). We conduct clinical trials to evaluate the safety and efficacy
of our investigational product buntanetap. Annovis encourages awareness of and
participation in our clinical trials. For information regarding Annovis-sponsored clinical
trials, please visit www.clinicaltrials.gov. Our current focus is to complete our ongoing
clinical trials to demonstrate safety and efficacy in order to obtain regulatory approval
and provide widespread availability of our investigational product buntanetap. Prior to
regulatory approval by the U.S. Food and Drug Administration (FDA), patients gain
access to investigational treatments, such as buntanetap, by participating in clinical
trials.
Expanded access, also called compassionate use, enables some patients with serious
or life-threatening diseases, who would not have otherwise met the enrollment criteria
for the clinical trials in progress, to gain access to investigational treatments. Currently,
Annovis does not offer an expanded access program. We believe that access to our
investigational product candidate should be limited to controlled clinical trials until such
time as their safety, tolerability and effectiveness have been determined and confirmed
by regulatory authorities. Accordingly, while clinical trials are ongoing, we believe
participation in our clinical trials is the only safe and appropriate way to access our
investigational product candidate.