Anavex Life Sciences Corp (AVXL)

[abew4me]

Baseline Characteristics from Evoke and Evoke+: Two Phase 3 Randomized Placebo-controlled Trials of Oral Semaglutide in Patients with Early Alzheimer’s Disease

[The results from these two P3 trials are expected by the end of Oct/Nov. Since this drug is already approved for Obesity and Diabetes, I'm sure doctors will start prescribing it immediately if the results are positive...so keep an eye out for this announcement. IMO this is our only competition]

Objective:
We report the preliminary baseline characteristics in the ongoing phase 3 evoke and evoke+ trials investigating the safety and efficacy of oral semaglutide for early AD.

Background:
Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), is approved for use in type 2 diabetes (T2D) or obesity.
Design/Methods:
evoke (NCT04777396) and evoke+ (NCT04777409) are multicenter, randomized, double-blind, placebo-controlled trials. Eligible individuals were 55–85 years, amyloid-positive, with mild cognitive impairment (MCI) due to AD and Mini-Mental State Examination (MMSE) score =22. Participants were randomized 1:1 to once-daily oral semaglutide 14 mg (titrated from 3 mg for the initial 4 weeks and 7 mg for the following 4 weeks) or placebo plus standard of care for 156 weeks (104 weeks + 52-week extension). The primary endpoint is change in the CDR – Sum of Boxes (CDR-SB). Baseline characteristics of enrolled patients were compiled after completion of enrollment on September 8, 2023. Trials are ongoing, data may be subject to minor changes until database lock.

Results:
evoke and evoke+ enrolled 1,855 and 1,835 participants each; data from 118 randomized participants from evoke+ are not included here. Mean (SD) age was 71.8 (7.1) and 72.6 (7.1) years; 53.0% and 51.8% of participants were female; most participants (76.6%) were White; 59.7% and 54.5% were in receipt of AD medication. Mean (SD) CDR-SB score was 3.7 (1.5) and 3.7 (1.6); ADCS-ADL-MCI score was 39.4 (7.3) and 38.9 (7.5); 72.5% and 68.7% of participants had a CDR global score of 0.5.

Conclusions:
evoke and evoke+ are the first large-scale phase 3 trials to investigate the disease-modifying potential of semaglutide in early AD. Both studies recruited a very similar population.

https://www.neurology.org/doi/10.1212/WNL.0000000000205079