Clinical Trial News

Keymed Biosciences announces NMPA approval of Stapokibart, an anti-IL-4Rα monoclonal antibody, for treating chronic rhinosinusitis with nasal polyposis. Positive phase III clinical trial results show significant improvements in nasal symptoms and quality of life.

Wave Life Sciences announced the submission of its first clinical trial application for WVE-007, an investigational siRNA designed to silence INHBE gene expression, inducing fat burning for sustainable weight loss without impacting muscle mass. Wave expects CTA approval and initiation of the first-in-human study in 1Q 2025.

Puma Biotechnology announced NCCN updated cervical cancer guidelines to include neratinib monotherapy for HER2-mutated tumors, based on Phase II SUMMIT trial results. This addition aims to improve treatment options for recurrent or metastatic disease.

Bristol Myers Squibb's Sotyktu met primary endpoint in Phase 3 psoriatic arthritis trials. Novo Nordisk's CagriSema fell short of weight loss projections, affecting stock. FDA granted breakthrough status to Neuralink's Blindsight and other devices. Vertex's Alyftrek approved for cystic fibrosis. Eli Lilly's Zepbound approved for sleep apnea, potentially reducing CPAP demand.

Eli Lilly's Zepbound (tirzepatide) received FDA approval for treating obesity and moderate to severe obstructive sleep apnoea (OSA). The decision was based on SURMOUNT-OSA Phase III trials showing Zepbound reduced breathing disruptions, with 42% and 50% of users achieving remission or mild OSA without and with PAP therapy, respectively. Zepbound also helped patients lose an average of 45 lbs (18% body weight) and 50 lbs (20% body weight) with PAP therapy. The drug, initially approved for obesity, is a GLP-1 receptor agonist also marketed for type 2 diabetes.

FDA approves GEMTESA® (vibegron), a β3 agonist, for men with OAB symptoms on BPH therapy, marking it the first and only such treatment available in the U.S.

NeuroSense Therapeutics entered a binding term sheet with a global pharma company for PrimeC, its ALS treatment, including substantial upfront payment, Phase 3 study funding, milestone payments, and double-digit royalties on net sales. The deal is subject to a definitive agreement expected in Q1 2025.

Siamak Daneshmand, MD, discusses TAR-200's safety, tolerability, and high complete response rates (85%) in NMIBC patients from the SunRISe-1 trial. He highlights the psychological benefits of a continuous drug release system and future potential for combination therapies.

Vivos Inc. initiates first human clinical trial for RadioGel® Precision Radionuclide Therapy™ in India, successfully treating five cancer patients. The trial aligns with the protocol designed for the Mayo Clinic, focusing on safety. Vivos continues discussions with the FDA to initiate trials in the U.S., aiming to expand to 30 patients and publish comprehensive data in 2025.

Gary Gibson hypothesizes that thiamine deficiency alters glucose metabolism in brain cells, leading to Alzheimer’s. His research culminated in the Benfoteam clinical trial evaluating benfotiamine, a thiamine precursor, for slowing Alzheimer’s progression. The trial aims to determine the highest safe dose and its efficacy in improving cognition and global function.