Pipeline

COMPLETED PHASE 3 STUDIES

Parkinson’s Study

A total of 471 patients completed Phase 3 study in early Parkinson’s disease. The results showed that buntanetap improved MDS-UPDRS Part II, Part III, Part II+III and Total scores in patients with a >3-year diagnosis as well as in patients with Postural Instability and Gait Difficulties (PIGD). Moreover, we noticed that cognition (MMSE) worsened over 6 months in placebo Parkinson's patients, whereas for buntanetap-treated patients cognitive decline was completely stopped.

Alzheimer’s Study

The study was completed with 345 patients, of which 90 were identified as having mild AD (MMSE 21-24). These 90 AD patients showed dose-dependent, statistically significant improvements from placebo in the two higher concentrations (15mg, p=0.042; 30mg, p=0.015) and all doses showed significant improvement over baseline (7.5mg, p= 0.013; 15mg p=0.001; 30mg p<0.001).

The data further showed that APOE4 carriers respond well to the drug improving by 3 - 4 points in ADAS-Cog11, similar to the response seen in non-carriers.

Improved cognition in mild AD patients (a) and, specifically, in APOE4 carriers (b)

For additional information see – News Releases

COMPLETED PHASE 2 STUDIES

Two Phase 2a studies in AD patients demonstrated an improvement in cognitive functions over baseline after 20-28 days of treatment with buntanetap.

In the Phase 2a Discover study, 60mg of buntanetap given for 20 days showed a strong trend in improving ADAS-Cog11 score, while in Phase 2a AD/PD study, 80mg buntanetap given over 25 days showed clinically significant improvement (p=0.04) in ADAS-Cog11 by 4.4 points from baseline and 3.3 points over placebo (MMSE 18-28).

Improved cognition (a) and speed/accuracy (b) in Alzheimer's

Data from 14 AD patients showed that ADAS-Cog11 improved by 4.4 points from baseline in the buntanetap-treated group, a statistically significant improvement of 30% (p<0.05). At 25 days, the treated group was also 3.3 points better than the placebo. The WAIS coding, which measured speed in movement and thinking, showed a statistically significant 23% improvement in AD patients treated with buntanetap compared to baseline.

Improved movement (a) and speed/accuracy (b) in Parkinson's

All buntanetap treatment groups combined showed statistically significant improvement in the MDS-UPDRS Part III and WAIS coding test. In this study, patients receiving 10mg and 20mg of buntanetap were the best performing groups. (* p<0.05; ** p<0.01; *** p<0.001).

Publication: Fang et al., 2022