AC Immune Reports Further Positive Interim Results from Phase 2 Trial of ACI-7104.056 Active Immunotherapy in Early Parkinson’s Disease
AC Immune (NASDAQ: ACIU) has reported positive interim results from its Phase 2 VacSYn clinical trial of ACI-7104.056, an active immunotherapy for early Parkinson's disease. The treatment has demonstrated significant efficacy, producing anti-α-synuclein antibody levels over 20-fold higher than placebo after 4 immunizations.
The trial's Part 1 involves over 30 patients randomized at a 3:1 ratio (treatment:placebo). Key findings show that antibody responses were effectively induced at week 6 after 2 immunizations and were further enhanced with additional doses. The treatment has shown a favorable safety profile with no serious adverse events reported, with only mild side effects including injection site reactions and headaches.
Based on upcoming interim results in 2025, including pharmacodynamic and biomarker data, the company may proceed with Part 2 of the trial, expanding to up to 150 patients. This phase will evaluate disease progression through motor and non-motor symptoms, along with digital, imaging, and fluid biomarkers.
AC Immune (NASDAQ: ACIU) ha riportato risultati intermedi positivi dal suo trial clinico di Fase 2 VacSYn per ACI-7104.056, un'immunoterapia attiva per il Parkinson in fase iniziale. Il trattamento ha dimostrato un'efficacia significativa, producendo livelli di anticorpi anti-α-sinucleina oltre 20 volte superiori rispetto al placebo dopo 4 immunizzazioni.
La Parte 1 dello studio coinvolge oltre 30 pazienti randomizzati in un rapporto di 3:1 (trattamento:placebo). I risultati chiave mostrano che le risposte anticorpali sono state efficacemente indotte alla settimana 6 dopo 2 immunizzazioni e sono state ulteriormente potenziate con dosi aggiuntive. Il trattamento ha mostrato un profilo di sicurezza favorevole, senza eventi avversi gravi segnalati, con solo lievi effetti collaterali, tra cui reazioni nel sito di iniezione e mal di testa.
In base ai risultati intermedi attesi nel 2025, compresi i dati farmacodinamici e sui biomarcatori, l'azienda potrebbe procedere con la Parte 2 dello studio, espandendosi fino a 150 pazienti. Questa fase valuterà la progressione della malattia attraverso sintomi motori e non motori, insieme a biomarcatori digitali, di imaging e fluidi.
AC Immune (NASDAQ: ACIU) ha reportado resultados interinos positivos de su ensayo clínico de Fase 2 VacSYn para ACI-7104.056, una inmunoterapia activa para la enfermedad de Parkinson en etapas tempranas. El tratamiento ha demostrado una eficacia significativa, produciendo niveles de anticuerpos anti-α-sinucleína más de 20 veces superiores al placebo después de 4 inmunizaciones.
La Parte 1 del ensayo involucra a más de 30 pacientes aleatorizados en una proporción de 3:1 (tratamiento:placebo). Los hallazgos clave muestran que las respuestas de anticuerpos se indujeron de manera efectiva en la semana 6 después de 2 inmunizaciones y se mejoraron con dosis adicionales. El tratamiento ha mostrado un perfil de seguridad favorable sin eventos adversos graves reportados, con solo efectos secundarios leves, incluyendo reacciones en el sitio de inyección y dolores de cabeza.
Basado en los próximos resultados interinos en 2025, incluidos datos farmacodinámicos y de biomarcadores, la empresa podría proceder con la Parte 2 del ensayo, expandiéndose hasta 150 pacientes. Esta fase evaluará la progresión de la enfermedad a través de síntomas motores y no motores, junto con biomarcadores digitales, de imagen y de fluidos.
AC Immune (NASDAQ: ACIU)는 초기 파킨슨병에 대한 활성 면역요법인 ACI-7104.056의 2상 VacSYn 임상 시험에서 긍정적인 중간 결과를 보고했습니다. 이 치료법은 4회 면역 접종 후 위약 대비 20배 이상 높은 항-α-시뉴클레인 항체 수준을 생성하는 데 상당한 효능을 보여주었습니다.
시험의 1부는 30명 이상의 환자가 3:1 비율(치료:위약)로 무작위 배정됩니다. 주요 발견은 2회 면역 접종 후 6주에 항체 반응이 효과적으로 유도되었으며 추가 용량으로 더욱 강화되었다는 것입니다. 이 치료법은 심각한 부작용이 보고되지 않은 우호적인 안전 프로필을 보여주었으며, 주사 부위 반응 및 두통과 같은 경미한 부작용만 있었습니다.
2025년의 중간 결과, 약리역학 및 바이오마커 데이터를 포함하여, 회사는 2부 시험을 진행할 수 있으며, 최대 150명의 환자로 확대할 수 있습니다. 이 단계에서는 운동 및 비운동 증상을 통해 질병 진행을 평가하고, 디지털, 영상 및 체액 바이오마커를 포함할 것입니다.
AC Immune (NASDAQ: ACIU) a rapporté des résultats intermédiaires positifs de son essai clinique de Phase 2 VacSYn pour ACI-7104.056, une immunothérapie active pour la maladie de Parkinson précoce. Le traitement a démontré une efficacité significative, produisant des niveaux d'anticorps anti-α-synucléine plus de 20 fois supérieurs à ceux du placebo après 4 immunisations.
La Partie 1 de l'essai implique plus de 30 patients randomisés dans un ratio de 3:1 (traitement:placebo). Les résultats clés montrent que les réponses anticorporelles ont été efficacement induites à la semaine 6 après 2 immunisations et ont été encore renforcées par des doses supplémentaires. Le traitement a montré un profil de sécurité favorable, sans événements indésirables graves signalés, avec seulement des effets secondaires légers, y compris des réactions au site d'injection et des maux de tête.
En fonction des résultats intermédiaires à venir en 2025, y compris les données pharmacodynamiques et sur les biomarqueurs, l'entreprise pourrait procéder à la Partie 2 de l'essai, en s'étendant à jusqu'à 150 patients. Cette phase évaluera la progression de la maladie à travers des symptômes moteurs et non moteurs, ainsi que des biomarqueurs numériques, d'imagerie et de fluides.
AC Immune (NASDAQ: ACIU) hat positive Zwischenresultate aus seiner Phase-2-VakSYn-Studie zu ACI-7104.056, einer aktiven Immuntherapie für die frühe Parkinson-Krankheit, berichtet. Die Behandlung hat eine signifikante Wirksamkeit gezeigt und erzeugte nach 4 Immunisierungen über 20-fach höhere Antikörperspiegel gegen α-Synuclein als das Placebo.
Teil 1 der Studie umfasst über 30 Patienten, die im Verhältnis 3:1 (Behandlung:Placebo) randomisiert wurden. Wichtige Ergebnisse zeigen, dass die Antikörperreaktionen nach 2 Immunisierungen in der Woche 6 effektiv induziert wurden und durch zusätzliche Dosen weiter verstärkt wurden. Die Behandlung hat ein günstiges Sicherheitsprofil gezeigt, ohne dass schwerwiegende unerwünschte Ereignisse berichtet wurden, lediglich leichte Nebenwirkungen wie Reaktionen an der Injektionsstelle und Kopfschmerzen traten auf.
Basierend auf den bevorstehenden Zwischenresultaten im Jahr 2025, einschließlich pharmakodynamischer und Biomarker-Daten, könnte das Unternehmen mit Teil 2 der Studie fortfahren und auf bis zu 150 Patienten ausweiten. Diese Phase wird den Krankheitsverlauf durch motorische und nicht-motorische Symptome sowie digitale, bildgebende und Flüssigkeits-Biomarker bewerten.
- Treatment shows strong efficacy with 20-fold higher antibody levels vs placebo
- Excellent safety profile with no serious adverse events reported
- Successful antibody response amplification with repeated immunizations
- Potential expansion to larger Phase 2 trial with 150 patients
- Phase 2 trial still in early stages with only 30 patients
- Final efficacy data and biomarker results not yet available
- Additional trial results pending until later in 2025
Insights
AC Immune's interim Phase 2 data for ACI-7104.056 provides encouraging early signals in their Parkinson's disease program. The 20-fold increase in anti-α-synuclein antibody levels compared to placebo after four immunizations demonstrates strong target engagement, a critical initial hurdle for any immunotherapy approach.
Most significantly, the reported boostability of the immune response with repeated immunizations suggests potential for sustained and increasing antibody levels over time. This characteristic is particularly valuable for neurodegenerative conditions requiring long-term treatment.
The safety profile appears favorable with no serious adverse events related to treatment reported to date - an important consideration as immunotherapy approaches can sometimes trigger concerning immune reactions. The mild injection site reactions and headaches are typical and manageable adverse events for vaccines.
However, these results primarily demonstrate successful immunogenicity rather than clinical efficacy. For AC Immune, a company with a relatively modest
Investors should note that further data expected later in 2025 will be crucial in determining whether these promising immunological responses translate to meaningful impacts on disease biomarkers and ultimately clinical outcomes.
AC Immune Reports Further Positive Interim Results from Phase 2 Trial of ACI-7104.056 Active Immunotherapy in Early Parkinson’s Disease
- Active immunotherapy with ACI-7104.056 induces high anti-a-synuclein (a-syn) antibody levels on average over 20-fold higher than placebo after 4 immunizations
- Repeated immunizations amplify the anti-a-syn antibody response, supporting boostability and the potential to further increase antibody titers
- ACI-7104.056 is well tolerated with no safety issues reported to date
Lausanne, Switzerland, April 2, 2025 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today announced additional interim safety and positive immunogenicity data from the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate, for the treatment of patients with early Parkinson’s disease (PD).
Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “We continue to be encouraged by the data emerging from the Phase 2 VacSYn trial of ACI-7104.056 active immunotherapy in early Parkinson’s disease. These additional interim safety and immunogenicity data after 6 months of treatment underscore the good safety profile and reinforce the best-in-class characteristics of ACI-7104.056 for the treatment of Parkinson’s disease. We look forward to sharing further updates later in 2025.”
VacSYn is an adaptive, placebo-controlled, and biomarker-based Phase 2 study in patients with early PD, consisting of two parts with a seamless transition. Part 1 includes initial analyses from over 30 patients randomized to receive ACI-7104.056 or placebo at a ratio of 3:1. To date, in the blinded, pooled active and placebo groups, no serious adverse event considered related to the study drug has been reported. The most common adverse events are mild and transient injection site reactions and headaches, generally of mild severity.
Interim results show positive antibody responses were effectively induced against the target antigen at week 6 after 2 immunizations and were further boosted by each additional immunization. Treatment with ACI-7104.056 induced an increase in anti-a-syn antibodies on average over 20-fold higher than the placebo background level after four immunizations.
Based on further interim results to be reported later in 2025 including pharmacodynamic and biomarker data, AC Immune may decide to initiate Part 2 of VacSYn with up to 150 patients. Further exploratory endpoints for patients in Part 2 will include the evaluation of the progression of motor and non-motor symptoms of the disease, as well as digital, imaging, and fluid biomarkers. The aim is to establish early proof-of-concept and identification of disease-specific biomarkers for rapid transition into a pivotal study.
About ACI-7104.056
ACI-7104.056 is an optimized formulation of its clinically validated anti-a-syn predecessor active immunotherapy which generated a target-specific antibody response against pathological oligomeric a-syn to inhibit spreading and downstream neurodegeneration in early Parkinson’s disease. The accumulation of alpha-synuclein protein aggregates has been shown to cause inflammatory stress in cells and contribute to the degeneration of neurons in the brain. It has been known to play a key role in the development of neurodegenerative diseases such as Parkinson’s Disease. Previous clinical studies showed the predecessor candidate produced a strong and boostable antibody response with evidence of target engagement and a signal of clinical efficacy.
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 broad and diversified 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 >
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 CN, CH, GB, JP, KR, NO and RU.
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:
| Head of Investor Relations & Corporate Communications Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com | International Media Chris Maggos Cohesion Bureau Phone: +41 79 367 6254 Email: chris.maggos@cohesionbureau.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 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.
Attachment
FAQ
What are the key results of ACIU's Phase 2 VacSYn trial for Parkinson's treatment?
How many patients are enrolled in ACIU's Phase 2 VacSYn trial Part 1?
What is the safety profile of ACIU's ACI-7104.056 in the Phase 2 trial?
When will ACIU report additional Phase 2 VacSYn trial results?
How many patients could be included in Part 2 of ACIU's VacSYn trial?
