Clinical Trial News

NeuroBo Pharmaceuticals completed enrollment for Phase 1 clinical trial of DA-1726, a dual oxyntomodulin analog agonist for obesity treatment, with 45 participants in 5 cohorts. The trial aims to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of DA-1726. Top-line data from the trial's SAD Part 1 is expected in Q3 2024, and from MAD Part 2 in Q1 2025. DA-1726 showed superior weight loss in pre-clinical data compared to other drugs, potentially positioning it as a best-in-class obesity drug.

FDA approves Nemluvio (nemolizumab) for treating adult patients with prurigo nodularis, based on positive results from the phase III OLYMPIA trials, demonstrating significant improvements in itch and skin nodules.

FDA approves Yorvipath (palopegteriparatide) for treating hypoparathyroidism in adults. Yorvipath, a once-daily prodrug of parathyroid hormone, aims to provide continuous PTH exposure. Ascendis plans to offer patient services and anticipates initial supply in Q1 2025, potentially earlier if FDA approves existing product. Safety concerns include risks of hypercalcemia, hypocalcemia, and osteosarcoma.

FDA approves Enzeevu (aflibercept-abzv), a biosimilar to Eylea, for intravitreal injection in patients with neovascular age-related macular degeneration (nAMD). Enzeevu is a key biosimilar value driver for Sandoz, extending its leading US ophthalmology portfolio. The approval is based on comprehensive analytical, preclinical, and clinical data from the Mylight study.

scPharmaceuticals announces FDA approval of sNDA expanding Furoscix indication in heart failure, now including NYHA Class IV patients.

LENZ Therapeutics submitted an NDA to the FDA for LNZ100, an aceclidine-based eye drop for treating presbyopia, supported by positive Phase 3 CLARITY study results.

Lykos Therapeutics received a complete response letter from the FDA for midomafetamine capsules for PTSD, requesting an additional Phase 3 trial. The company plans to meet with the FDA to discuss resubmission and address concerns raised during the Advisory Committee meeting.

First patients enrolled in US pivotal study of AI-based image analysis module for lung cancer by Invenio Imaging, in collaboration with Johnson & Johnson and multiple cancer centers.

FDA approves neffy (epinephrine nasal spray) 2 mg for Type I Allergic Reactions, including anaphylaxis, in adults and children ≥30 kg, marking the first needle-free epinephrine treatment innovation in over 35 years.

FDA approves Lymphir (denileukin diftitox-cxdl) immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. Lymphir targets the interleukin-2 (IL-2) receptor on malignant T-cells and Tregs, offering rapid skin relief without cumulative toxicity. The approval is based on a Phase 3 study showing a 36.2% Objective Response Rate (ORR) with 8.7% achieving Complete Response (CR), and a median time to response of 1.4 months.