AC Immune's ACI-19626 PET tracer shows increased uptake in ALS patients, indicating potential for early diagnosis in neurodegenerative diseases.
Quiver AI Summary
AC Immune SA has presented new preliminary Phase 1 data on its TDP-43 PET tracer, ACI-19626, at the 2026 TDP43 Summit, showing increased uptake in the brains of patients with amyotrophic lateral sclerosis (ALS). The data indicate that ACI-19626 is effective in detecting TDP-43 pathology in ALS patients, particularly in brain regions associated with the disease, such as the brain stem and precentral gyrus. Previously reported findings also indicated high tracer uptake in patients with genetically defined frontotemporal dementia (FTD). The tracer demonstrates good safety and tolerability, suggesting its suitability for human brain imaging and potential use in pharmacodynamic analysis of TDP-43-targeting therapies. AC Immune's CEO emphasized the tracer's promise for early diagnosis and intervention in neurodegenerative diseases, reinforcing the company's commitment to precision medicine. The ongoing trial aims to include further patient cohorts, underscoring the potential for significant advancements in biomarker development for these complex conditions.
Potential Positives
- Presentation of new Phase 1 data on ACI-19626 at a significant summit reinforces AC Immune's position as a leader in neurodegenerative disease research.
- Increased uptake of the TDP-43 PET tracer in ALS patients suggests strong potential for early diagnosis and intervention in neurodegenerative diseases.
- Positive safety and tolerability profile of ACI-19626 supports its development for clinical applications in brain imaging and therapeutic analysis.
- Demonstrated potential for ACI-19626 to aid in precision medicine approaches, enhancing AC Immune's therapeutic pipeline and impact in the field.
Potential Negatives
- Data presented is preliminary and from an ongoing Phase 1 trial, which may not reflect the final efficacy or safety of ACI-19626, raising concerns about the reliability of the results.
- The mention of “higher uptake” in PET scans requires further validation, and initial results may not translate to clinical relevance, potentially affecting investor and market confidence.
- Forward-looking statements highlight significant risks and uncertainties that could lead to actual results differing materially from expectations, which may create skepticism about future developments.
FAQ
What is ACI-19626 and its significance in ALS?
ACI-19626 is a first-in-class TDP-43 PET tracer showing increased uptake in ALS patients, aiding early diagnosis of neurodegenerative diseases.
How does ACI-19626 perform in detecting TDP-43 pathology?
The tracer has shown significantly higher uptake in ALS patients compared to healthy controls, indicating its effectiveness in detecting TDP-43.
What were the results of the Phase 1 trial presented at the summit?
The Phase 1 trial data showed that ACI-19626 detected higher TDP-43 pathology in key brain regions of ALS patients.
What implications does this data have for precision medicine?
These findings underline ACI-19626's potential for enabling early diagnosis and intervention in multiple neurodegenerative diseases through precision medicine.
What is the current status of the ACI-19626 trial?
The ongoing Phase 1 trial includes healthy volunteers and patients with FTD, ALS, or LATE, with a Part 2 expansion underway.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
AC Immune Presents New Phase 1 Data Indicating Higher Uptake of TDP-43 PET Tracer ACI-19626 in Patients with ALS
- Presentation at 2026 TDP43 Summit shows ACI-19626 detects TDP-43 pathology in patients with amyotrophic lateral sclerosis (ALS)
- Previously reported data also showed detection of TDP-43 in patients with genetically defined frontotemporal dementia (FTD)
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Underlines potential for precision medicine enabling early diagnosis and intervention in multiple neurodegenerative diseases
Lausanne, Switzerland, May 22, 2026 -- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today announced the presentation of new preliminary data from a Phase 1 trial of its first-in-class TDP-43 positron emission tomography (PET) tracer ACI-19626 showing increased uptake in the brains of patients with amyotrophic lateral sclerosis (ALS).
The results presented at the 2026 TDP43 Summit in Madison, Wisconsin, demonstrate that PET scans with ACI-19626 showed tracer uptake significantly higher in key regions of the brain in patients with ALS compared to healthy controls. Specifically, tracer uptake was higher in the brain stem (* see image below) and precentral gyrus, where TDP-43 pathology is expected to accumulate based on post-mortem neuropathology studies and on clinical symptoms. Previously reported data showed significantly higher tracer uptake in disease-relevant subcortical and cortical regions in patients with genetic frontotemporal dementia (FTD).
ACI-19626 continues to show good safety and tolerability, a dosimetry profile within accepted limits, and rapid brain uptake and washout, indicating a pharmacokinetic (PK) profile suitable for human brain imaging and potentially pharmacodynamic analysis of therapeutics targeting TDP-43 pathology.
Dr. Andrea Pfeifer, CEO of AC Immune SA , commented: “These data in ALS patients provide further evidence of ACI-19626’s potential to detect pathological TDP-43 in the brains of patients with TDP-43 proteinopathies. Early diagnosis is essential for early intervention, and the data generated so far on ACI-19626 further underline the promise of the AC Immune pipeline and our technology to enable a precision medicine approach to multiple neurodegenerative diseases.”
The ongoing Phase 1, first-in-human trial ( Clinicaltrials.gov : NCT06891716 ) has two parts. Part 1 investigating ACI-19626 in healthy volunteers and patients with genetic FTD is completed. The Part 2 expansion has started and may include up to 30 patients with FTD, ALS or LATE.
The 2026 Summit Advancing TDP43 Biomarkers is hosted by the University of Wisconsin–Madison and the Wisconsin Alzheimer’s Disease Research Center’s (ADRC) Consortium for Clarity in ADRD Research Through Imaging (CLARiTI).
* Post-hoc analysis from expert third-party independent of the study (for informational purposes only and does not constitute official, final data)
About TDP-43
TDP-43 is the main component in inclusions found in the brains of people with FTD, ALS and limbic-predominant age-related TDP-43 encephalopathy (LATE), as well as a co-pathology in Alzheimer’s disease (AD) and Parkinson’s disease (PD). These conditions share many of the same clinical signs and symptoms, making differential diagnosis a difficult and lengthy process in the absence of reliable biomarkers.
About AC Immune SA
AC Immune SA is a clinical-stage biopharmaceutical company and a global leader in precision prevention for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its pipeline of first- and best-in-class assets, which currently features a range of therapeutic and diagnostic programs, including candidates in Phase 2 and Phase 3 development. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >$4.5 billion in potential milestone payments plus royalties.
SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CA, CN, CH, EU, GB, JP, KR, NO, RU and SG.
The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release.
For further information, please contact:
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SVP, Investor Relations & Corporate Communications
Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: [email protected] |
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International Media
Chris Maggos Cohesion Bureau Phone: +41 79 367 6254 Email: [email protected] |
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 Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.
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