Clinical Trial News

Two patients in the Phase 1/2a trial of troculeucel, an NK cell therapy for Alzheimer's disease, improved from moderate to mild AD after three months at the highest dose of 6 billion cells per treatment. The first Phase 2 patient was dosed at the same high dose, marking progress in the trial.

Moberg Pharma AB announced lower-than-expected clinical cure rates in a subset of patients in the ongoing North American Phase 3 study for MOB-015 against nail fungus, increasing the risk of non-commercialization in the US. The study, involving 384 patients at 33 centers, is crucial for MOB-015's US registration and differs from EU-approved studies by reducing dosage. The company will await topline results before drawing conclusions.

Two new drugs for hypercalcaemia in patients with parathyroid carcinoma and primary hyperparathyroidism approved under Hong Kong's '1+' mechanism, which simplifies drug registration by requiring approval from one reference place and local clinical data.

Mount Sinai Health System and IBM Research launch PREDiCTOR study to predict mental health outcomes using AI and behavioral data from clinical interviews, smartphones, and cognitive testing, funded by a $20 million NIMH grant.

Advancements in HER2-positive breast cancer treatment emphasize personalized, less toxic regimens, with trials like APT, ATEMPT, and TRAIN-2 showing high invasive disease-free survival rates and reduced cardiotoxicity. Ongoing trials, such as ATEMPT 2.0 and CompassHER2 RD, aim to further tailor treatments based on individual patient factors and address specific challenges like central nervous system recurrences. The future of HER2-positive breast cancer treatment is focused on personalized medicine and understanding resistance mechanisms to HER2-targeting agents.

E7820, Eisai's targeted protein degrader, showed tumor shrinkage in 38.1% of PDX models, particularly 58.3% in bile duct and 55.6% in uterine cancers. Whole-exome sequencing identified HRR gene mutations as predictive biomarkers. An investigator-initiated clinical study will evaluate E7820's safety and efficacy in Japanese patients with solid tumors.

FDA declined accelerated approval for Moderna and Merck’s mRNA-4157 melanoma vaccine, citing challenges in reviewing AI-developed drugs, despite ongoing discussions.

Halozyme announces FDA approval for Tecentriq Hybreza™, a subcutaneous anti-PD-(L)1 immunotherapy using ENHANZE® technology, reducing injection time to 7 minutes from 30-60 minutes for IV infusion, available for adult indications of IV Tecentriq®.

EQBMED announces Amgen and Merck as sponsors for local clinical trial sites, focusing on oncology and cardiovascular disease, aiming to enhance diversity in clinical trials.

Ebglyss, a new first-line biologic treatment for moderate-to-severe atopic dermatitis, offers significant skin clearance within four weeks and itch relief in two weeks. It provides long-lasting efficacy through monthly maintenance doses, approved by the FDA for adults and children 12 years and older who weigh at least 88 pounds (40 kg) and have inadequate response to topical therapies.