Clinical Trial News

In a clinical trial, 141 patients had fungal culture speciation and MIC data for natamycin and voriconazole. Aspergillus and Fusarium were the most common organisms. No MIC-outcome associations were found overall, but voriconazole MIC was linked to Fusarium cases needing keratoplasty and visual acuity issues.

OCT-guided PCI of complex coronary lesions is superior to angiography-guided PCI for CV outcomes at 1 year, with a 5% vs. 7% major adverse cardiac events rate. The trial compared OCT-guided (n = 803) vs. angiography-guided (n = 801) PCI in 1,604 patients, using everolimus-eluting stents. OCT guidance led to greater contrast use and longer procedure times but reduced ischemia-driven target lesion revascularization.

The REC-CAGEFREE I trial found that PCI with paclitaxel-coated balloon was inferior to traditional DES PCI for multiple CV outcomes at 2 years among patients with de novo lesions. The trial aimed to assess the safety and efficacy of a paclitaxel-coated balloon (DCB) compared to drug-eluting stent (DES) implantation. The study involved 2,272 patients randomized to either DCB or DES, with follow-up for 734 days. The primary outcome showed DCB was not noninferior to DES (6.4% vs. 3.4%, p for noninferiority = 0.65), with inferior outcomes particularly in larger vessels. Small vessel disease showed comparable outcomes between DCB and DES.

Elixir Medical's INFINITY-SWEDEHEART trial of DynamX Bioadaptor meets primary endpoint of target lesion failure (TLF) non-inferiority at 12 months, with low event rates despite complex patient population. Landmark analysis shows significant reduction in TLF and target vessel failure (TVF) after six months, confirming the unique mechanism of action.

Arrowhead Pharmaceuticals is preparing two RNAi-based drugs for obesity and metabolic diseases, aiming to start clinical trials early next year.

The SPEC-AI Nigeria trial evaluated AI-guided ECG-based screening vs. clinical ECGs alone for identifying cardiomyopathy among pregnant/postpartum women in Nigeria, utilizing AI algorithms for ECG analysis. The trial, funded by Mayo Clinic and NIH, involved six hospitals, with participants aged 18-49, randomized to AI-guided screening or standard ECG, followed up to 12 months postpartum. The primary outcome was identification of LVEF < 50% by echocardiography, with secondary outcomes including AI model performance and effectiveness in identifying various LVEF levels.

DR.NOAH BIOTECH received FDA approval for the IND application for a Phase 1 clinical trial of NDC-011, a new drug combination for ALS, developed using their AI platform ARK.

Pulmonary vein isolation significantly reduced atrial fibrillation burden at 6 months, with substantial improvements in symptoms and quality of life compared to a sham procedure, indicating no placebo effect.

Johnson & Johnson submitted a BLA to the FDA for nipocalimab, an investigational therapy for generalized myasthenia gravis (gMG), based on data from the Phase III Vivacity-MG3 trial. Nipocalimab, an FcRn blocker, showed sustained disease control in gMG patients over 24 weeks, marking the longest controlled safety and efficacy assessment in this patient group.

IDMC recommended continuation of IO Biotech's Phase 3 trial of IO102-IO103 without modifications after a safety and efficacy interim analysis. No new safety signals were observed, and the primary endpoint of progression-free survival is projected to be reached in the first half of 2025.