Drugs

NeurMedix Cleared to Begin Phase 3 Alzheimer’s Trial

FDA has given the green light to NeurMedix to begin a pivotal Phase 3 clinical trial to evaluate its lead drug candidate, NE3107 in Alzheimer’s disease patients. The planned 316-patient placebo-controlled trial (NCT04669028) of the small molecule, orally administered, anti-inflammatory, insulin-sensitizing agent with a novel mechanism of action will be conducted at about 30 clinical sites in the U.S., according to the company.

“The rationale for the trial is based on growing scientific evidence linking inflammation and insulin resistance to Alzheimer’s disease dementia and progression,” NeurMedix says. “The recently coined term, ‘Type 3 diabetes,’ underscores the close link between Alzheimer’s disease and insulin resistance that develops from inflammatory inactivation of the insulin signaling pathway in the brains of Alzheimer’s patients. Inflammation has long been known as a major driver of Alzheimer’s disease, but currently approved anti-inflammatory agents, and potentially those in development, are poorly suited to chronic use in Alzheimer’s due to one or more factors relating to poor blood-brain barrier penetration, toxicity and side effects, or mechanisms of action that are too narrow to be effective against the multiplicity of inflammatory pathways that are activated in the disease.”

To address these issues, NE3107 is designed as a highly blood-brain barrier permeable drug with a low potential for toxicity that targets the major inflammation signaling pathways, those mediated by extracellular signal regulated kinase, nuclear factor kappa-light-chain-enhancer of activated B cells, and tumor necrosis factor (TNF) , the company says. It believes that NE3107’s combination of small molecule characteristics and broad mechanism of action without immunosuppressive effects provides advantages over protein-based TNF inhibiting therapies, as well as antibodies against amyloid beta and phospho-tau.

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