Clinical Trial News

A study found brolucizumab non-inferior to aflibercept in treating DME, with superior anatomic outcomes. Both drugs showed similar adverse event rates. The meta-analysis underscores the need for further trials to assess safety outcomes for brolucizumab as a DME treatment alternative.

FDA approves Zepbound, first medication for moderate to severe obstructive sleep apnea in obese adults, to be used with diet and exercise. Zepbound, also known as Mounjaro, reduces appetite and improves OSA by reducing body weight, with significant reduction in apnea/hypopnea events and weight loss in studies.

Targeted therapies for metastatic colorectal cancer (mCRC) are moving to earlier treatment lines, emphasizing the importance of molecular testing. Key options include anti-EGFR therapy for RAS wild-type patients, BRAF V600E inhibitors like encorafenib, and HER2-directed therapies such as trastuzumab plus tucatinib. Ongoing trials aim to integrate these therapies into first-line settings, including MOUNTAINEER-03 for HER2-positive patients and studies on new RAS-targeted therapies.

Researchers identified three osteosarcoma subtypes using Latent Process Decomposition, potentially transforming clinical trials and patient care. This method considers tumor heterogeneity, revealing subtypes with varied responses to standard chemotherapy, enabling more targeted treatments.

BioGenCell received FDA Fast Track Designation for BGC101, a personalized cell therapy for severe CLTI. BGC101, using the TRACT platform, regenerates damaged tissue, offering hope to patients with no other treatment options. The designation follows promising clinical results from Phase 2 trial enrollment across the US, Europe, and Israel.

The FDA approved Eli Lilly's Zepbound (tirzepatide) for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity, based on SURMOUNT-OSA trials showing significant reductions in apnea-hypopnea index (AHI) and substantial weight loss. Zepbound, which reduces appetite and food intake, offers a new non-invasive treatment option for OSA, a condition affecting 30 million Americans but significantly underdiagnosed. Common side effects include gastrointestinal issues, and patients with a history of medullary thyroid carcinoma should avoid the drug.

This study investigates the implementation of SPARCK, a parent training intervention, in a hybrid effectiveness-implementation trial. It examines the relations between implementation determinants and outcomes, and their impact on clinical outcomes. The study uses a longitudinal design, collecting data from practitioners and leaders over three time points, and employs multilevel models for analysis.

FDA approves Eli Lilly's Zepbound for obesity and moderate-to-severe obstructive sleep apnea, marking the first drug treatment for OSA. Zepbound should be used with a reduced-calorie diet and increased physical activity. Approval may impact insurance coverage, giving Eli Lilly an edge over Novo Nordisk. Clinical trials showed nearly half of patients experienced disease resolution.

RH5.1/Matrix-M, a blood-stage malaria vaccine, shows promising results in Phase IIb trial, potentially becoming the first of its kind. It complements pre-erythrocytic vaccines, offering a second line of defence against malaria, with 55% efficacy against clinical malaria and 80% in reducing high parasite levels. The vaccine targets the blood stage, occurring after liver infection, and could significantly aid global malaria prevention efforts.

Zepbound, a weight loss drug, is now the first to treat sleep apnea, impacting nearly 40 million people.