AC Immune’s active-immunotherapy candidate, ACI-35.030, now renamed JNJ-2056, has been granted FDA Fast Track designation for Alzheimer’s disease treatment. This pivotal development highlights the therapy’s potential to significantly benefit patients with Alzheimer’s by targeting the pathologic form of the Tau protein, phosphorylated Tau (pTau). The newly initiated Phase 2b clinical trial, ReTain, aims to recruit participants with preclinical Alzheimer’s disease who have yet to show clinical symptoms, representing a groundbreaking approach in treating this condition.
The Phase 2b ReTain trial is a randomized, multicenter, double-blind, placebo-controlled study, potentially enabling registration. The trial will assess the clinical effect of active immunization with JNJ-2056. Approximately 500 participants with preclinical Alzheimer’s (cognitively normal but Tau positive) will be randomized to receive either JNJ-2056 or placebo via intramuscular injections over four years. The primary endpoint is cognitive decline measured by the Preclinical AD Cognitive Composite 5 (PACC-5) score, while secondary endpoints include the effect on Tau pathology propagation as measured by Tau PET imaging.
JNJ-2056’s potential to revolutionize Alzheimer’s treatment
JNJ-2056, developed from AC Immune’s SupraAntigen® platform, has shown in clinical studies to induce a robust polyclonal antibody response against key pathological forms of Tau. This investigational candidate aims to enhance the formation of protective antibodies against pTau, potentially reducing or preventing disease progression in early Alzheimer’s stages. By inhibiting the seeding and spreading of pathological Tau, JNJ-2056 could delay or prevent cognitive impairment or other clinical symptoms in individuals with preclinical Alzheimer’s disease.
JNJ-2056 is being developed through a global license, development, and commercialization agreement with Janssen Pharmaceuticals, a Johnson & Johnson company. The ReTain trial, fully funded and conducted by Janssen, underscores the strong collaboration between the two companies. This partnership leverages AC Immune’s innovative research and Janssen’s robust clinical development capabilities to advance Alzheimer’s treatment.
AC Immune’s commitment to neurodegenerative disease research
AC Immune SA is a clinical-stage biopharmaceutical company leading in precision medicine for neurodegenerative diseases. With its clinically validated technology platforms, SupraAntigen® and Morphomer®, AC Immune drives a diversified pipeline of first- and best-in-class assets. The company’s commitment to developing new mechanisms of action and innovative therapeutics is evident in its broad portfolio, including sixteen therapeutic and diagnostic programs, five in Phase 2 and one in Phase 3 clinical trials.
The Fast Track designation of JNJ-2056 by the FDA offers opportunities for more efficient development and regulatory review, potentially accelerating the availability of this innovative treatment. AC Immune, alongside its partners, continues to pioneer advancements in Alzheimer’s disease treatment, aiming to provide safe, simple-to-use therapies for the millions affected by this debilitating condition. This development represents a significant step towards improving patient outcomes and reducing the global burden of Alzheimer’s disease.
Resource: AC Immune, July 25, 2024
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