Clinical Trial News

Switching JIA patients from anti-TNF originators to biosimilars showed similar disease activity and drug persistence, with low switching back rates, supporting biosimilar safety and effectiveness.

Aura Biosciences' new therapy, bel-sar, for early-stage choroidal melanoma shows promise in Phase II trials, potentially offering a vision-preserving alternative to radiation therapy. The treatment uses virus-drug conjugates activated by light to target tumors, with results indicating high efficacy and safety. Aura plans to advance to Phase III trials and explore broader cancer applications.

Moderna plans to file for three vaccine approvals by year-end, cutting R&D spending by 20% and dropping five drug candidates from its pipeline. The company aims for 10 approvals by 2027, focusing on critical vaccines like next-gen COVID, flu-COVID combo, and RSV for high-risk adults under 60.

Zepbound, an injectable weight-loss drug, shows better efficacy in women, with up to 25% weight loss compared to 19% in men. Tirzepatide, the active ingredient, consistently reduced weight in both sexes, but more research is needed to understand why women experience greater weight reduction.

Dimerix opens first paediatric site in Mexico for ACTION3 Phase 3 trial of DMX-200 to treat FSGS, with 14 more sites planned across Argentina, US, and UK. Dr Howard Trachtman joins the Medical Advisory Board to support paediatric recruitment. The trial aims to recruit 22 adolescent patients, with DMX-200 dosage confirmed for adolescents. Recruitment for the trial remains on track, with funding secured through various sources.

Doherty Clinical Trials seeks healthy volunteers for Phase I trial of Vaxxas' needle-free avian influenza vaccine using High-Density Microarray Patch (HD-MAP) technology, which delivers vaccine to immune cells below skin surface. Previous trials showed promising results in administering seasonal influenza, COVID-19, and measles and rubella vaccines. The study, enrolling 258 participants aged 18-50, aims to assess safety and tolerability, with participants undergoing nine visits over 13 months for medical examinations and blood tests. Participants will be reimbursed for their time and expenses.

FDA grants breakthrough therapy designation to Neuraptive Therapeutics’ NTX-001 for peripheral nerve injury treatment, based on Phase II NEUROFUSE study results. Neuraptive plans to initiate a Phase III programme in early 2025, including a randomized, double-blind, placebo-controlled trial. The final study protocol is under discussion with the FDA, with full 48-week data expected soon.

Alzheimer's drugs Leqembi and Kisunla may work by boosting levels of healthy amyloid beta (Aβ42) protein, countering Alzheimer's progression, according to a University of Cincinnati study.

CRISPR-Cas9 gene editing in France targets intronic regions of the DMD gene, restoring the open reading frame and dystrophin expression in myogenic cells with exon 2, 2–9, or 8–9 duplications, offering a potential therapeutic avenue for DMD patients not covered by existing exon-skipping therapies.

CD137 antibodies show promise in cancer immunotherapy by stimulating T cells, with no licensed drugs yet but over 80 in clinical trials, mainly in phase 2. Major companies like BioNTech and Genmab are developing these therapies, which could enhance existing treatments and expand to other diseases. The market potential is significant, with challenges in dosing and resistance needing resolution.