AC Immune SA Reports Interim Data for Down Syndrome Trial
Ticker: ACIU · Form: 6-K · Filed: Dec 10, 2024 · CIK: 1651625
| Field | Detail |
|---|---|
| Company | Ac Immune SA (ACIU) |
| Form Type | 6-K |
| Filed Date | Dec 10, 2024 |
| Risk Level | medium |
| Pages | 2 |
| Reading Time | 2 min |
| Sentiment | neutral |
Sentiment: neutral
Topics: clinical-trial-data, biotech, down-syndrome, press-release
TL;DR
AC Immune SA drops interim safety data for Down syndrome drug ACI-24.060.
AI Summary
On December 10, 2024, AC Immune SA announced interim safety and tolerability data from its ABATE Phase 1b/2 trial for ACI-24.060, an immunotherapy targeting amyloid beta in individuals with Down syndrome. The analysis included data from the first two cohorts receiving low-dose and mid-dose treatments.
Why It Matters
This trial investigates a novel approach to potentially treat conditions associated with amyloid beta, which could have implications for neurodegenerative diseases.
Risk Assessment
Risk Level: medium — The company is reporting early-stage trial data, which carries inherent uncertainty regarding efficacy and future development success.
Key Players & Entities
- AC Immune SA (company) — Registrant
- ACI-24.060 (drug) — Investigational immunotherapy
- Down syndrome (condition) — Target patient population
- December 10, 2024 (date) — Date of press release
FAQ
What specific safety or tolerability data was reported in the interim analysis?
The filing states that interim safety and tolerability data was reported, but does not provide specific details within the provided text.
What is the mechanism of action for ACI-24.060?
ACI-24.060 is an active immunotherapy designed to target toxic forms of amyloid beta (Abeta), specifically covering Abeta 1-15 while excluding Abeta T-cell epitopes.
How many cohorts of patients were included in the interim analysis?
The interim analysis was based on data from the first two cohorts of individuals with Down syndrome.
What is the trial phase for ACI-24.060 in individuals with Down syndrome?
The trial is a Phase 1b/2 study.
What is the filing date and period of report for this 6-K?
The filing was made on December 10, 2024, and the period of report is also December 10, 2024.
Filing Stats: 490 words · 2 min read · ~2 pages · Grade level 10.9 · Accepted 2024-12-10 08:23:56
Filing Documents
- dp221876_6k.htm (6-K) — 13KB
- dp221876_ex9901.htm (EX-99.1) — 20KB
- image_001.jpg (GRAPHIC) — 2KB
- 0000950103-24-017481.txt ( ) — 37KB
From the Filing
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of December, 2024 Commission file number: 001-37891 AC IMMUNE SA (Exact Name of Registrant as Specified in Its Charter) EPFL Innovation Park Building B 1015 Lausanne, Switzerland (Address of Principal Executive Offices) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F Form 40-F On December 10, 2024, AC Immune SA issued a press release reporting interim safety and tolerability data from the ABATE Phase 1b/2 trial of ACI-24.060 in individuals living with Down syndrome (DS). Targeting toxic forms of amyloid beta (Abeta), ACI-24.060 is an active immunotherapy covering Abeta 1-15 (excluding Abeta T-cell epitopes). The interim analysis was based on data from the first two cohorts of individuals with DS receiving low-dose and mid-dose ACI-24.060. DS subjects in the interim analysis have been treated for up to one year, with no serious adverse events related to the study drug and no case of amyloid-related imaging abnormalities (ARIA) observed in this study population. The ongoing ABATE study (NCT05462106) is a randomized, double-blind, placebo-controlled Phase 1b/2 trial assessing the safety, tolerability, immunogenicity and pharmacodynamic effects of the investigational immunotherapy. The study was specifically designed to support parallel development in individuals with prodromal Alzheimer’s disease (AD) and non-demented adults with DS, a vulnerable population predisposed to developing AD. ACI-24.060 has received Fast Track designation from the U.S. FDA for the treatment of AD. The Company previously reported positive interim safety, tolerability, and immunogenicity from the AD cohorts of the ABATE trial, which supported the treatment with ACI-24.060 in individuals with DS in ABATE. The trial will now start to evaluate the high dose of ACI-24.060 in additional patients with DS. Recruitment of individuals with DS continues at ABATE trial sites in the U.S., U.K., and Spain. A copy of the press release is attached as Exhibit 99.1 to this Report on Form 6-K. This Report on Form 6-K (other than Exhibit 99.1 hereto) shall be deemed to be incorporated by reference into the registration statements on Form F-3 (File Nos. 333-227016, 333-249655 and 333-277940) and Form S-8 (File Nos. 333-213865, 333-216539 and 333-233019) of AC Immune SA and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished. EXHIBIT INDEX Exhibit Number Description 99.1 Press Release dated December 10, 2024 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. AC IMMUNE SA By: /s/ Andrea Pfeifer Name: Andrea Pfeifer Title: Chief Executive Officer By: /s/ Christopher Roberts Name: Christopher Roberts Title: Chief Financial Officer Date: December 10, 2024