Author Archives: Patricia Inacio PhD

Gosuranemab, an investigational antibody against the tau protein, failed to meet its primary and exploratory efficacy goals in the TANGO Phase 2 study, its developer, Biogen, has announced. Now, the TANGO trial has been terminated and Biogen will cease the clinical development of gosuranemab as a potential therapy for…

Annovis Bio’s oral therapy ANVS401 (also known as Posiphen) led to significant improvements in cognition in patients with Alzheimer’s disease, according to data from the first patient group in a Phase 2a study. The improvements were also observed in patients with Parkinson’s disease enrolled in the…

ProMIS Neurosciences will advance the development of PMN310, its manmade antibody designed to target the toxic forms of amyloid beta that underlie Alzheimer’s disease. The first step in the manufacturing of PMN310 will be carried out by Selexis with its proprietary CHO-K1 cell line, part of the company’s…

Longeveron’s Lomecel-B, an investigational bone marrow-derived medicinal signaling cell (MSC), showed an ability to slow cognitive decline and the loss of daily life abilities in patients with mild Alzheimer’s disease relative to those given a placebo in a Phase 1 clinical trial, the company announced. Treatment with Lomecel-B was deemed safe,…

NeurMedix has announced it will soon open a pivotal Phase 3 clinical trial of its lead investigational therapy, NE3107, for people with Alzheimer’s disease, following authorization by the U.S. Food and Drug Administration (FDA). The trial (NCT04669028), to be conducted at about 30 clinical U.S. sites, will be looking to…

Cognito Therapeutic’s neurostimulation device — a next-generation digital therapeutic designed to treat memory and cognition symptoms in Alzheimer’s disease — has been granted a breakthrough device designation by the U.S. Food and Drug Administration (FDA). The device, part of a new class of disease-modifying digital therapies, uses proprietary,…

Fujirebio Diagnostics has submitted a premarket notification — also known as a 510(k) — to the U.S. Food and Drug Administration (FDA) for its Alzheimer’s diagnostic test, called Lumipulse G β-Amyloid Ratio (1-42/1-40). If cleared by the FDA, it will be among the first commercially available lab tests to…

Biogen and Eisai are seeking approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease in Japan, the companies have announced. If approved, aducanumab will become the first therapy with the potential to slow the clinical decline seen in patients with Alzheimer’s. “The filing of the application is…

AlzeCure Pharma is preparing to launch a Phase 1 clinical trial in Sweden to evaluate the tolerability and safety of ACD856, one of its therapy candidates for Alzheimer’s disease, the company announced. The trial follows the release of the first positive clinical results, in which ACD856 showed…

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Axsome Therapeutics‘ AXS-05, an investigational oral therapy for the treatment of agitation in people with Alzheimer’s disease. This designation is intended to accelerate the development and review of potential…