The US Food and Drug Administration (FDA) has granted fast track designation to Life Molecular Imaging’s (LMI) tau positron emission tomography (PET) imaging diagnostic, PI-2620.
The designation has been granted for the clinical application of PI-2620 for tau PET imaging in Alzheimer’s disease, progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD).
PI-2620 PET imaging is a technique whereby a patient is injected with a small amount of PI-2620 tracer, which subsequently travels through the bloodstream and binds to any tau proteins in the brain.
From there, patients undergo a PET scan that detects signals emitted by PI-2620. The resultant PET images show if there are tau deposits in the brain and in which regions they are located, thereby aiding in the diagnosis and monitoring of the progression of Alzheimer’s and other neurodegenerative conditions in which tau deposits have been implicated.
PI-2620 is currently under investigation in a Phase III trial (NCT05641688) by LMI to assess the efficacy and safety of PET imaging with PI-2620 for the detection of tau deposits in subjects with Alzheimer’s.
“This designation not only validates our approach but also facilitates closer collaboration with the FDA to expedite the development of PI-2620,” said LMI CMO Andrew Stephens.
“We are committed to advancing this important imaging agent with the potential to make a meaningful difference for patients who need accurate and accessible tau PET imaging.”
PI-2620 was developed in collaboration with AC Immune. Primarily focused on developing treatments for neurodegenerative diseases, the Swiss biotech works with other firms and develops drug candidates through its Morphomer and SupraAntigen technology platforms.
Morphomer is capable of creating small molecules that bind to misfolded proteins such as amyloid beta (Aβ), while SupraAntigen generates monoclonal antibodies to specifically target misfolding proteins.
The FDA has previously granted fast track designation to two of AC Immune’s immunotherapies, ACI-35-030 (NCT04445831) and ACI-24060. The compounds target tau and Aβ, respectively.
In January 2023, AC Immune reported positive data from the ABATE trial (NCT05462106) of anti-amyloid-beta (Abeta) vaccine ACI-24060, finding that the compound elicited an anti-Abeta antibody response in ABATE’s first low-dose cohort of AD patients at week six.
“The designation for PI-2620 is a further recognition of AC Immune’s drug discovery and development platform and of how we, together with our partners, continue to drive innovation,” commented AC Immune CEO Andrea Pfeifer.
GlobalData’s pharmaceutical database shows that AC Immune has a pipeline of 20 drugs, chiefly for neurodegenerative conditions, in active stages of development.
The 2024 Alzheimer’s Association International Conference (AAIC) took place in Philadelphia, US from 28 July to 1 August. During the conference, Eisai announced that patients undergoing continuous treatment with its anti-amyloid therapy Leqembi for three years had shown a slowing of Alzheimer’s disease progression. Leqembi received full market approval from the FDA in July 2023.
