Buntanetap showed dose-dependent and statistically significant improvements in cognition in the overall enrolled PD population. Parkinson’s patients with substantial cognitive decline exhibited a very pronounced improvement.
Buntanetap showed statistical improvement in the MDS-UPDRS Part II, Part III, Part II+III and Total scores in Parkinson’s patients with a >3-year diagnosis.
Buntanetap showed the same statistical improvement in MDS-UPDRS Part II, Part III, Part II+III and Total scores in Parkinson’s patients with Postural Instability and Gait Difficulties (PIGD).
Buntanetap’s activity resulted in statistically significant improvements in all primary and secondary endpoints in the specified populations as well as in cognition.
These findings will be discussed in more detail on today's webcast at 4:30 PM ET. Register here.
FDA and Endpoint Clarification: Recent questions regarding the primary and secondary endpoints in MDS-UPDRS scores warrants additional explanation. Initially, Annovis chose MDS-UPDRS Part II+III as the primary endpoint. However, based on FDA feedback, MDS-UPDRS Part II alone was deemed more appropriate for reflecting clinically relevant changes (Goetz et al., 2023). Consequently, we adjusted our primary endpoint to MDS-UPDRS Part II, with MDS-UPDRS Part III as a key secondary endpoint. Our results met both primary and secondary endpoints in the specified subgroups.
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