AC Immune Reports Positive Interim Results from Phase 2 Trial of ACI-7104.056 Active Immunotherapy in Early Parkinson’s Disease
AC Immune (NASDAQ: ACIU) announced positive interim results from its Phase 2 VacSYn trial of ACI-7104.056, an active immunotherapy for early Parkinson's disease. The treatment showed significant efficacy, inducing anti-a-synuclein antibody levels 16-fold higher than placebo after 3 immunizations, with a 100% patient response rate. The trial reported positive safety data with only minor side effects including injection site reactions (49%) and headaches (18%). The study may expand to Part 2 with up to 150 patients in H1 2025, focusing on motor symptoms and biomarkers for potential pivotal study transition.
AC Immune (NASDAQ: ACIU) ha annunciato risultati intermedi positivi dal suo trial di Fase 2 VacSYn relativo a ACI-7104.056, una immunoterapia attiva per il morbo di Parkinson in fase iniziale. Il trattamento ha mostrato un'efficacia significativa, inducendo livelli di anticorpi anti-a-sinucleina 16 volte superiori rispetto al placebo dopo 3 immunizzazioni, con un tasso di risposta dei pazienti del 100%. Il trial ha riportato dati di sicurezza positivi, con solo effetti collaterali minori, tra cui reazioni nel sito di iniezione (49%) e mal di testa (18%). Lo studio potrebbe espandersi nella Parte 2 con fino a 150 pazienti nel primo semestre del 2025, concentrandosi sui sintomi motori e sui biomarcatori per una potenziale transizione a uno studio cruciale.
AC Immune (NASDAQ: ACIU) anunció resultados interinos positivos de su ensayo de Fase 2 VacSYn para ACI-7104.056, una inmunoterapia activa para la enfermedad de Parkinson en etapas tempranas. El tratamiento mostró una eficacia significativa, induciendo niveles de anticuerpos anti-a-sinucleina 16 veces superiores al placebo tras 3 inmunizaciones, con una tasa de respuesta del 100% entre los pacientes. El ensayo reportó datos de seguridad positivos, con solo efectos secundarios menores, incluyendo reacciones en el sitio de inyección (49%) y dolores de cabeza (18%). El estudio podría expandirse a la Parte 2 con hasta 150 pacientes en el primer semestre de 2025, enfocándose en síntomas motores y biomarcadores para una posible transición a un estudio pivotal.
AC Immune (NASDAQ: ACIU)는 초기 파킨슨병에 대한 능동 면역요법인 ACI-7104.056의 2상 VacSYn 시험에서 긍정적인 중간 결과를 발표했습니다. 이 치료법은 3회의 면역화 후 위약보다 16배 높은 항체 수준을 유도하며, 100%의 환자 반응률을 보였습니다. 시험에서는 경미한 부작용으로 주사 부위 반응(49%)과 두통(18%)이 보고되는 긍정적인 안전성 데이터를 확인했습니다. 이 연구는 2025년 상반기에 최대 150명의 환자로 2부로 확대될 수 있으며, 운동 증상 및 잠재적인 주요 연구 전환을 위한 바이오마커에 집중할 예정입니다.
AC Immune (NASDAQ: ACIU) a annoncé des résultats intermédiaires positifs de son essai de Phase 2 VacSYn concernant ACI-7104.056, une immunothérapie active pour la maladie de Parkinson à un stade précoce. Le traitement a montré une efficacité significative, induisant des niveaux d'anticorps anti-a-synucleine 16 fois plus élevés que le placebo après 3 immunisations, avec un taux de réponse des patients de 100%. L'essai a rapporté des données de sécurité positives, avec seulement des effets secondaires mineurs, y compris des réactions au site d'injection (49%) et des maux de tête (18%). L'étude pourrait s'étendre à la Partie 2 avec jusqu'à 150 patients au premier semestre 2025, en se concentrant sur les symptômes moteurs et les biomarqueurs pour une transition potentielle vers une étude pivot.
AC Immune (NASDAQ: ACIU) gab positive vorläufige Ergebnisse aus seiner Phase-2-Studie VacSYn zu ACI-7104.056, einer aktiven Immuntherapie gegen frühe Parkinson-Krankheit, bekannt. Die Behandlung zeigte eine signifikante Wirksamkeit, mit einer Induktion von Anti-alpha-Synuclein-Antikörpern, die 16-mal höher als im Placebo waren, nach 3 Immunisierungen, und einer 100%igen Patientenansprechrate. Die Studie berichtete von positiven Sicherheitsdaten mit nur geringen Nebenwirkungen, einschließlich Reaktionen an der Injektionsstelle (49%) und Kopfschmerzen (18%). Die Studie könnte in Teil 2 mit bis zu 150 Patienten im ersten Halbjahr 2025 ausgeweitet werden, mit dem Fokus auf motorische Symptome und Biomarker für den potenziellen Übergang zu einer pivotalen Studie.
- 100% patient response rate to the target antigen
- 16-fold higher antibody levels compared to placebo
- FDA Fast Track designation obtained
- Strong safety profile with only minor side effects
- Potential expansion to larger Phase 2 trial with 150 patients
- Additional clinical efficacy data still pending
- Further interim results and expansion decision delayed until H1 2025
Insights
The interim Phase 2 results for ACI-7104.056 show remarkable promise in early Parkinson's disease treatment. The 16-fold increase in anti-α-synuclein antibodies compared to placebo and 100% response rate are particularly impressive biomarkers. The safety profile appears strong, with only mild side effects like injection site reactions and headaches.
The adaptive trial design is strategically sound, allowing for efficient progression to Part 2 based on interim results. The comprehensive biomarker evaluation plan, including motor symptoms, digital metrics and imaging, will provide robust efficacy data. The FDA Fast Track designation adds regulatory momentum, potentially accelerating the development timeline.
However, investors should note these are early results from just 30 patients and the true clinical benefit in slowing disease progression remains to be demonstrated in the larger Part 2 study planned for up to 150 patients.
AC Immune Reports 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 antibody levels on average 16-fold higher than placebo after 3 immunizations
100% of patients receiving ACI-7104.056 responded against the target antigen- ACI-7104.056 is well tolerated with no clinically relevant safety issues reported to date
Lausanne, Switzerland, November 14, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today announced positive interim safety and 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 are encouraged by these initial Phase 2 safety and immunogenicity data on our ACI-7104.056 active immunotherapy being studied in early Parkinson’s disease. The level of immunogenicity after only 3 months of treatment as well as the continued positive safety profile, reinforces the best-in-class characteristics of our clinically validated anti-a-syn active immunotherapy for the treatment of Parkinson’s disease. We look forward to sharing further updates in H1 2025 including the decision to expand into Part 2 of the VacSYn study.”
Dr. Pfeifer added, “As a leader in active immunotherapies for neurodegenerative diseases with two FDA Fast Track designated candidates, an important recognition of their promise, we are delighted with these initial VacSYn data. They further support the approach of using active immunotherapies to target the hallmark pathological proteins of neurodegenerative diseases, such as a-synuclein in Parkinson’s disease, before irreversible damage occurs.”
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-7104.56 or placebo at a ratio of 3:1. To date, no clinically relevant safety issues have been reported other than transient injection site reactions (
Interim results show positive antibody responses were effectively induced against the target antigen at week 6 after 2 immunizations and were strongly boostable. Treatment with ACI-7104.056 induced an increase in anti-a-syn antibodies on average 16-fold higher than the placebo background level after three immunizations.
Based on further interim results to be reported in H1 2025 including pharmacodynamic data, AC Immune may decide to initiate Part 2 of VacSYn with up to 150 patients. Patients from Part 2 will also be evaluated for 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 sixteen therapeutic and diagnostic programs, including five in Phase 2 development and one in Phase 3. 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 | U.S. Investors Christina Tartaglia Precision AQ Phone: +1 212 362 1200 Email: christina.tartaglia@precisionaq.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.
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