Drugs

Alector Scraps Dementia Drug After Missing Key Endpoint

Alector’s efforts to advance a therapy for a rare genetic form of frontotemporal dementia (FTD) to market has ended in disappointment. The company reports that latozinemab (AL001) failed to meet its primary endpoint in a Phase 3 study, prompting the biotech to wind down the development program.

The INFRONT-3 trial, a 96-week, placebo-controlled study conducted in collaboration with GSK, tested latozinemab in patients with FTD caused by mutations in the progranulin gene (FTD-GRN), according to the company. While the treatment successfully boosted levels of the progranulin protein — a biomarker linked to disease biology — it did not slow clinical progression as measured by a composite dementia rating scale, it says. Secondary and exploratory analyses, including MRI and other biomarker measures, also showed no signs of efficacy.

“While latozinemab did not demonstrate a clinical benefit in INFRONT-3, the insights gained are invaluable for understanding progranulin-related neurodegeneration,” said Chief Medical Officer Giacomo Salvadore in a statement. The company plans to present full results at an upcoming medical meeting.

Alector says its collaboration with GSK will continue with nivisnebart (AL101/GSK4527226), which is now being evaluated in the PROGRESS-AD Phase 2 trial for early Alzheimer’s disease. Enrollment was completed in April and a trial readout is expected next year.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome