SOUTH SAN FRANCISCO, Calif. - Alector, Inc. (NASDAQ:ALEC) in collaboration with GSK plc (LSE/NYSE:GSK), announced that the U.S. Food and Drug Administration (FDA) has awarded Breakthrough Therapy Designation to latozinemab, a treatment under investigation for frontotemporal dementia with a progranulin gene mutation (FTD-GRN). This development marks latozinemab as the first investigational medicine to receive such designation for FTD-GRN, a rare and rapidly progressing neurodegenerative disease.
The FDA's Breakthrough Therapy Designation is intended to expedite the development and review process for drugs that could significantly improve treatment for serious conditions. Latozinemab, a human monoclonal antibody, targets the sortilin receptor to increase levels of progranulin, a critical regulator of immune activity in the brain linked to various neurodegenerative disorders.
The designation was based on data from the INVOKE-2 Phase 2 clinical trial and comes as the INFRONT-3 Phase 3 study, which reached its target enrollment in October 2023, continues. Despite the prevalence of FTD, affecting an estimated 50,000 to 60,000 people in the United States, there are currently no FDA-approved treatments for the condition.
Alector and GSK began their partnership in July 2021, with Alector receiving $700M upfront and the potential for up to $1.5B in additional milestone payments. The companies will share profits and losses equally in the United States, while Alector is set to receive tiered royalties on sales outside of the U.S.
Alector is a biotechnology firm focused on immuno-neurology, seeking to address neurodegenerative diseases by targeting immune system dysfunction. The company is developing a portfolio of programs to potentially treat conditions like Alzheimer's disease and genetically defined frontotemporal dementia.
This announcement is based on a press release statement and contains forward-looking statements that involve risks and uncertainties. The implications of the Breakthrough Therapy Designation and the success of ongoing clinical trials are subject to these risks. Alector's forward-looking statements are based on expectations and beliefs as of the date of the press release, and the company disclaims any obligation to update these statements.
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