AC Immune's PI-2620 Tau-PET Diagnostic in Phase 3 Gets Fast Track for Three Neurodegenerative Conditions

AC Immune SA, a clinical-stage biopharmaceutical company known for its precision therapeutics targeting neurodegenerative diseases, announced that its Tau positron emission tomography (PET) diagnostic, PI-2620, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). This designation applies to PI-2620's clinical development in three neurodegenerative conditions: Alzheimer's disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD).

The FDA’s Fast Track program is designed to expedite the development and review processes for drugs that address serious medical conditions and meet unmet medical needs. This recognition highlights the growing emphasis within the medical community on the importance of early and accurate diagnosis of neurodegenerative diseases. Improved diagnostic capabilities may lead to better patient outcomes as new treatments continue to emerge.

PI-2620 is a next-generation PET imaging agent currently in Phase 3 clinical development for detecting Tau pathology specifically in Alzheimer's disease. It is also being researched for its diagnostic potential in other neurodegenerative conditions by various academic institutions and pharmaceutical trials. Accurate imaging of Tau proteins, which are a hallmark of diseases including AD, PSP, CBD, and frontotemporal lobar dementia (FTLD), could significantly enhance disease diagnosis and patient care.

Dr. Andrea Pfeifer, CEO of AC Immune, remarked that the Fast Track designation for PI-2620 underscores its potential in diagnosing Alzheimer’s and other neurodegenerative diseases. Early diagnosis is crucial for effective treatment before irreversible damage occurs, which aligns with AC Immune’s strategy of precision prevention. The FDA had previously granted Fast Track status to two of AC Immune’s active immunotherapies: ACI-35.030 and ACI-24.060, which are in Phase 2 development targeting phospho-Tau and Abeta, respectively. The recognition for PI-2620 further validates AC Immune’s innovative drug discovery and development platform.

PI-2620 was discovered and developed through a collaboration between AC Immune and Life Molecular Imaging (LMI), which holds the exclusive, worldwide license for its research, development, and commercialization. The PET imaging agent has demonstrated robust brain uptake and rapid clearance from non-target regions, offering a broad imaging window between 30 and 90 minutes post-injection for Alzheimer's disease. It also boasts excellent reproducibility between initial and follow-up scans. The absence of significant off-target binding allows PI-2620 to detect and quantify early Tau deposits in the brain, a critical feature for diagnosing neurodegenerative diseases. The agent is currently being investigated in several clinical studies as a targeted radiopharmaceutical for detecting Tau accumulations in the brain. PI-2620 also shows promise for diagnosing non-Alzheimer’s tauopathies like PSP and corticobasal syndrome (CBS).

AC Immune is a leader in precision prevention for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and rare neurodegenerative conditions caused by misfolded proteins. The company’s technology platforms, SupraAntigen® and Morphomer®, support a diverse pipeline of therapeutic and diagnostic programs, including several in advanced clinical stages. AC Immune has established strategic partnerships with leading global pharmaceutical companies, securing significant non-dilutive funding to advance its proprietary programs. The company has the potential to receive over $4.5 billion in milestone payments and royalties from these partnerships.

In summary, the Fast Track Designation from the FDA for PI-2620 underscores its potential to revolutionize the early diagnosis and treatment of neurodegenerative diseases, reinforcing AC Immune’s position as a leader in precision medicine for these conditions.