Clinical Trial News

RAPT Therapeutics and Jemincare entered an exclusive license agreement for JYB1904 (RPT904), a half-life extended anti-IgE monoclonal antibody. RAPT gains worldwide rights excluding China, paying Jemincare $35M upfront, up to $672.5M in milestones, and royalties. Jemincare conducts Phase 2 trials in asthma and chronic spontaneous urticaria in China, while RAPT plans a Phase 2b trial in food allergy in 2025.

Blarcamesine, an oral Alzheimer’s treatment, demonstrated efficacy in slowing clinical decline in early Alzheimer's patients, with a favorable safety profile. The European Medicines Agency accepted Anavex Life Sciences' Marketing Authorization Application for review.

Glaukos submitted an NDA to the FDA for Epioxa, a non-invasive corneal cross-linking therapy for keratoconus, aiming to reduce procedure times, improve comfort, and shorten recovery. The submission includes data from two successful Phase 3 trials.

Bristol Myers Squibb announces European Commission approval of Opdivo and Yervoy as first-line treatment for MSI-H/dMMR metastatic colorectal cancer, based on Phase 3 CheckMate -8HW trial results showing 79% reduction in disease progression or death risk compared to chemotherapy. The approval extends across all 27 EU member states, Iceland, Liechtenstein, and Norway.

Zura Bio Limited initiates Phase 2 TibuSURE trial to evaluate tibulizumab in systemic sclerosis, targeting IL-17A and BAFF. The study aims to address unmet medical needs with a 24-week efficacy period and a 28-week extension. Zura Bio maintains strong financial health and plans additional trials for hidradenitis suppurativa.

FDA approves weight-loss drug Zepbound for moderate to severe obstructive sleep apnea in obese individuals, to be used with diet and exercise. Clinical trials showed significant improvements in sleep apnea symptoms and weight loss, with potential for insurance coverage under Medicare.

SeaStar Medical activates 14th site for NEUTRALIZE-AKI trial, evaluating SCD device for AKI patients on CRRT. 70 of 200 planned subjects enrolled, with interim analysis expected mid-2025. SCD targets hyperinflammation, with potential U.S. market of $4.7B-$6.3B for AKI treatment.

Protalix BioTherapeutics, Inc. shares accomplishments in 2024, including EMA validation for pegunigalsidase alfa dosing, phase I trial results for PRX-115, and repayment of convertible notes. The company looks forward to advancing PRX-115 and pipeline developments in 2025.

UiB researchers discovered NAD's role in cellular energy metabolism and vital functions, with mitochondria acting as NAD reservoirs. Dysregulated NAD levels link to aging and diseases like cancer, diabetes, and neurodegenerative disorders. NAD supplementation shows promise in clinical trials.