Clinical Trial News

HUTCHMED announces the NDA for ORPATHYS® and TAGRISSO® combination for EGFR mutation-positive NSCLC with MET amplification has been accepted by China's NMPA, triggering a milestone payment from AstraZeneca. The SACHI trial supports the NDA, showing improved PFS. HUTCHMED and AstraZeneca aim to enhance NSCLC treatment continuity and quality of life.

LimmaTech Biologics AG received FDA Fast Track designation for LBT-SA7, a vaccine targeting Staphylococcus aureus infections, aiming to expedite its development. LBT-SA7, designed to prevent SSTIs by neutralizing toxins, will undergo Phase 1 trials in the U.S. with results expected in 2025.

A study on 61 subjects with primary immunodeficiency evaluated the efficacy, pharmacokinetics, and safety of IGSC 20% for IgG replacement. The SBI rate was 0.017 per person per year, with a 99% upper confidence limit of 0.036. Mean trough IgG concentrations were comparable to previous regimens. Seven subjects had serious TEAEs, none drug-related. IGSC 20% was well tolerated, with a safety profile similar to IGIV-C 10%.

Faricimab treatment for nAMD showed improved or stabilized visual acuity and reduced retina thickness in a large study. Patients extended injection intervals while maintaining disease control. Faricimab targets VEGF and angiopoietin-2, potentially offering greater efficacy and reduced systemic risks compared to anti-VEGF-only treatments.

Mercury Biomed received a $1.5 million Phase II STTR grant from NIGMS to advance WarmSmart, a device for peri-operative patient warming. This funding supports clinical trials at Cleveland Clinic, aiming for FDA clearance. WarmSmart offers a novel, non-invasive approach to maintain normothermia, addressing a $2.5 billion market.

The FDA authorized AstraZeneca's Evusheld, a COVID-19 treatment combining tixagevimab and cilgavimab, for unvaccinated individuals aged 12+ with medical constraints. It's not a vaccine substitute, effective for six months pre-exposure, and reduces COVID-19 risk by 77%. Side effects include allergic reactions and fatigue.

The FDA has granted fast track designation to arfolitixorin, a treatment for metastatic colorectal cancer, highlighting its potential to meet unmet clinical needs and offer more effective treatment options. The drug is currently under evaluation in a phase 3 clinical trial.

A randomized clinical trial compared Minocycline Extended-Release to Doxycycline for rosacea treatment, focusing on efficacy and safety in a head-to-head study.

Duchenne muscular dystrophy (DMD), affecting 1 in 5000 males, is caused by mutations in the DMD gene, leading to muscle degeneration due to dystrophin absence. Gene therapy using AAV vectors to restore dystrophin shows promise, with ongoing clinical trials. Challenges include optimizing dosage, immune response, and manufacturing for effective treatment.

A clinical trial published in Cancer Discovery reveals that a fasting-mimicking diet (FMD) is safe and may modulate metabolism and boost antitumor immunity in cancer patients. The study, involving 101 patients with various tumor types, demonstrated significant metabolic and immunological benefits, including reduced blood glucose and growth factor concentrations, and enhanced intratumor T-cell infiltration.