Annovis Bio’s share price increased by 100% following positive Phase III data. Credit: rafapress via Shutterstock.

Annovis Bio has shared delayed data from its Phase III trial showing that its lead candidate buntanetap (previously ANVS401 or Posiphen) improved cognition in patients with Parkinson’s disease.

The Pennsylvania, US-headquartered company shared data focused on a subgroup analysis, touting significant improvements in both MDS-UPDRS Part II, Part III and Phase II+III scores for the 20mg buntanetap dose compared to placebo and baseline in patients diagnosed more than three years ago.

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Another subgroup analysis highlighted significant improvements on MDS-UPDRS Part II, Part III, Part II+III, and total scores in patients with postural instability and gait difficulty (PIGD). This subset of patients is associated with faster disease progression.

The company’s share price closed 76% higher than the previous day following the 2 July announcement. 

The company had initially selected MDS-UPDRS Part II+III as the primary endpoint, but ultimately focused on Part II only following US Food and Drug Administration (FDA) feedback, as this was “deemed more appropriate for reflecting clinically relevant changes.” Consequently, MDS-UPDRS Part III was made a secondary outcome measure. Buntanetap met both of these endpoints in patients who have been diagnosed for more than three years.

This data is long-awaited, with Annovis previously reporting that it would be published in January 2024. In January the biotech said the timeline had been delayed due to “ongoing data cleaning efforts to ensure accuracy and reliability of the study results.”

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The trial (NCT05357989) enrolled 523 patients who received either 10mg or 20mg of buntanetap or placebo. Buntanetap inhibits the formation of neurotoxic proteins like amyloid beta, tau, alpha-synuclein, and TDP43. It aims to reverse neurodegeneration in Parkinson’s and Alzheimer’s by improving synaptic transmission and reducing neuroinflammation.

The company shared data from a Phase II/III clinical trial of buntanetap in Alzheimer’s disease (NCT05686044) in April 2024. This 320-patient trial failed to meet a co-primary endpoint, leading to a drop in company’s share price. Additionally, Annovis announced that there had been a patient screening issue, sharing that the initial recruitment for the trial did not include pre-screening for Alzheimer’s biomarkers in the plasma. Annovis plans to move onto a Phase III trial regardless of this data.

In the announcement accompanying the data, Annovis’ CEO Maria Maccecchini said: “These compelling data reinforce our commitment to advancing buntanetap into a longer study, which will allow us not only to verify observed symptomatic improvements but also to explore buntanetap’s disease-modifying properties.”