AC Immune Opens New Centers in Phase 1b/2 Trial Evaluating ACI-24 Targeting Abeta in Alzheimer’s Disease and Down Syndrome
- Interim analysis expected around year-end 2022, informing Phase 2 start
- Trial progressing with regulatory clearances in the
UK and also now inSpain - Planned submission of
U.S. Investigational New Drug application in Q1 2023 - Continues progress towards prevention of neurodegenerative diseases
LAUSANNE,
Dr.
ABATE is an ongoing two-part, multicenter, placebo-controlled phase 1b/2 trial evaluating the safety, tolerability, immunogenicity and pharmacodynamic effect of ACI-24.060. The biomarker-based design of the ABATE trial, with multiple interim analyses, will enable early and informed decision-making with rapid de-risking of the study and a safe transition into the more vulnerable DS population. Only patients with prodromal AD are enrolled in part 1, while part 2 focuses on individuals living with DS.
Prof. Johannes Streffer, CMO of
The first interim analysis of the Phase 1b part of the study is expected around the end of 2022, enabling progression into Phase 2 in individuals with DS. The combination of the two study populations, which display striking similarities in their biomarker patterns, provides important learnings between prodromal AD and individuals with DS, a population at extreme risk of developing AD. The trial design provides multiple opportunities to accelerate development, in terms of expansion of this study and the initiation of pivotal and prevention trials.
References:
- Vukicevic et al, An amyloid beta vaccine that safely drives immunity to a key pathological species in Alzheimer’s disease: pyroglutamate amyloid beta,
Brain Communications , Volume 4, Issue 1, 2022 - Sol et al, Biomarker-based development for optimized ACI-24, a novel candidate vaccine for the treatment and prevention of Alzheimer’s disease, in-person-poster, AAIC congress,
San Diego, CA , USA,July 31, 2022
About the ABATE Phase 1b/2 Study
The ABATE study is a phase 1b/2, multicenter, adaptive, double-blind, randomized, placebo-controlled study to assess the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer’s disease and in adults with Down syndrome. All participants in the trial must have brain Abeta pathology confirmed by a positron emission tomography (PET) scan. The trial begins with a dose escalation phase in AD patients, during which various doses/dosing regimens can be evaluated. Upon identification of an optimal dose and dosing regimen, the trial is planned to advance to an expansion phase in patients with AD and the initiation of the cohort in non-demented individuals living with DS.
About ACI-24.060
ACI-24.060, derived from AC Immune’s SupraAntigen® platform, induces a strong polyclonal antibody response that matures and is maintained against both oligomeric and pyroglutamate-Abeta species, key pathological forms of Abeta believed to drive Abeta plaque formation and disease progression1,2. Importantly, antibodies against pyroglutamate Abeta have been shown to efficiently promote clearance of existing plaques in patients. ACI-24.060 is designed to enhance the formation of broad-spectrum protective antibodies with the same safety and tolerability previously demonstrated in the ACI-24 program in Phase 1 and 2 trials. This investigational candidate has the potential to efficiently inhibit plaque formation and increase plaque clearance, and thereby may reduce or prevent disease progression.
About
SupraAntigen® is a registered trademark of
For further information, please contact:
Media Relations Phone: +41 21 345 91 34 Email: saoyuth.nidh@acimmune.com |
Investor Relations Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com |
LaVoieHealthScience Phone: +1 609 516 5761 Email: slewis@lavoiehealthscience.com |
U.S. Investors Phone: +1 212 915 2577 Email: cdavis@lifesciadvisors.com |
Forward looking statements
This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the
Source: AC Immune SA