Treatment with Aduhelm (aducanumab) showed a significant correlation with lower blood levels of p-tau181, a disease biomarker, and lesser cognitive and functional decline in Alzheimer’s patients, according to a recent data analysis of two Phase 3 clinical trials. The data, analyzed from around 7,000 blood samples collected from more than 1,800 patients who participated in the EMERGE…
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1st Patient Enrolled in Phase 1 Trial of Antibody Therapy BHV-1100
Biohaven Pharmaceuticals has begun enrolling patients in its Phase 1a/1b trial testing the company’s antibody-recruiting molecule (ARM) called BHV-1100. The trial (NCT04634435) seeks to recruit 25 adults with newly diagnosed multiple myeloma who have minimal residual disease in first remission before a stem cell transplant. One patient has now been enrolled. The trial will assess…
EMA Committee Votes Against Approving Aduhelm in Europe
A European Medicines Agency (EMA) committee has voted against approving Biogen’s Aduhelm (aducanumab) as a treatment for Alzheimer’s disease. The EMA’s Committee for Medicinal Products for Human Use, known as CHMP, is expected to issue a formal ruling based on this so-called negative trend vote after its meeting in mid-December. But the regulatory agency usually follows…
Auction Photo Shows How Alzheimer’s Can Unravel Patient’s Crocheting
At first glance, it’s a simple photo of eight small crochet works posted in three rows on a light-color backdrop and contained in a wooden frame. But there’s much more to it than that. The photo is a visual representation of the progressive effect of Alzheimer’s as put together by the daughter of the artist,…
GC012F, CAR-T Cell Therapy Candidate, Granted FDA Orphan Drug Status
Gracell Biotechnologies’ investigational new treatment for multiple myeloma, GC012F, has been named an orphan drug by the U.S. Food and Drug Administration (FDA). Orphan drug status is intended to encourage the development of therapies for rare diseases affecting fewer than 200,000 people in the U.S. It provides benefits and incentives, including exemption from FDA application…
Vaccine Sparking Immune Reaction Against Toxic Tau Proteins in Trial
An investigation vaccine for Alzheimer’s disease, ACI-35.030 by AC Immune, induced a potent production of antibodies against toxic forms of tau protein — a Alzheimer’s hallmark — in patients with early stage disease, interim results of an ongoing Phase 1b/2a trial show. “These promising results … will be invaluable as we work to further ACI-35.030’s clinical development…
2 Blood Biomarkers May Be Used to Monitor Lecanemab’s Efficacy
The blood levels of two biomarkers of Alzheimer’s disease are significantly associated with changes in brain beta-amyloid deposits and cognitive function in early Alzheimer’s patients treated with lecanemab (BAN2401), according to a new analysis of data from a Phase 2b clinical trial. The results suggest that these blood biomarkers — p-tau181 and beta-amyloid fragments —…
Tau NexGen Trial Now Also Testing Anti-Amyloid Therapy Lecanemab
The Tau Next Generation (Tau NexGen) clinical trial will now be evaluating an anti-amyloid antibody in addition to an anti-tau antibody as a potential treatment for early onset Alzheimer’s disease, according to a press release. BioArctic and Eisai‘s investigational treatment lecanemab has been selected as the background anti-amyloid agent to be used for the first arm of…
UK Groups Want Rights for Care-home Visitors During COVID-19 Pandemic
A coalition of dementia organizations is calling on the U.K. government to help care-home residents maintain physical contact with loved ones during the COVID-19 pandemic. Called One Dementia Voice, the coalition acknowledges the difficulties of balancing the risk of COVID-19 against the potential harm done by isolation. However, it is seeking to have the government…
FDA Approves 8th Darzalex Faspro Indication for Myeloma Patients
The U.S. Food and Drug Administration (FDA) has approved Darzalex Faspro (daratumumab and hyaluronidase), in combination with Kyprolis (carfilzomib) and the corticosteroid dexamethasone, for the treatment of adults with multiple myeloma who have received one to three lines of therapy. Darzalex Faspro is a subcutaneous, or under-the-skin, formulation of the Janssen laboratory-made therapy Darzalex (daratumumab),…
2 Women on Mission to Raise Awareness in Latino Community
When Enma Espinosa worked during the day and her husband, Francisco Espinosa, worked the night shift, they barely saw each other. So it took longer for her to realize the small changes in his cognition were not just a normal part of aging. It wasn’t until her husband’s barber called to inform Espinosa that he…
Phase 2/3 Trial of ATH-1017 for Mild or Moderate Alzheimer’s Enrolling
Athira Pharma announced its Phase 2 ACT-AD trial is fully enrolled and its Phase 2/3 LIFT-AD trial has reached more than half of its target number. Both studies are evaluating the safety and efficacy of ATH-1017 in people with mild to moderate Alzheimer’s disease. Eligible adults, ages 55 to 85, are still being recruited for…