Clinical Trial News

Study evaluates automated scoring of Home Sleep Apnea Testing (HSAT) and a two-stage model for OSA in primary care, using the STOP-BANG questionnaire followed by HSAT with automated scoring. Results show strong correlation between automated and manual HSAT scoring, with the two-stage model demonstrating good diagnostic properties. The study highlights the potential of automated HSAT scoring in primary care, reducing referrals by 15.3% and achieving substantial interrater agreement with manual scoring.

Matregenix secures $4.2M in AFWERX Phase II contracts for nanofiber tech in soft tissue repair, enhancing national defense.

A Phase II/III FAST design with 2 interim assessments and a final assessment examines the impact of interim assessments' timing on final operating characteristics. The Phase II portion includes arm-dropping and feasibility analyses, while the Phase III portion involves a generalized linear model with a gatekeeping procedure to control type 1 error.

Kintara Therapeutics provides corporate and REM-001 clinical study updates, including a merger agreement with TuHURA Biosciences and a special stockholder meeting on September 20, 2024. The REM-001 study for cutaneous metastatic breast cancer has enrolled four of ten needed patients, with no safety issues identified.

The FDA is prioritizing the review of suzetrigine, a non-opioid analgesic developed by Vertex Pharmaceuticals, potentially marking the first new class of pain medication in over two decades. While initially hopeful, the author is concerned about the drug's efficacy and the FDA's motivations for fast-tracking it, questioning if it's another 'false flag' in the search for effective non-opioid pain treatments.

At EASD 2024, Boehringer Ingelheim's survodutide, a GCGR/GLP-1R dual agonist, showed 40% of overweight/obese patients achieved >20% weight loss after 46 weeks, with no plateau. For MASH, it reduced blood pressure significantly. Safety concerns were due to rapid dose escalation, which could be mitigated by gradual escalation. No direct correlation between amino acid levels and muscle loss was found. Key opinion leaders find a GCGR/GLP-1R dual agonist desirable for weight, glucose, and blood pressure reduction, improving lipids, and sustaining metabolic rate.

NURE-Combo trial evaluated nivolumab + nab-paclitaxel as neoadjuvant therapy for MIBC, followed by RC and adjuvant nivolumab. 31 patients enrolled; 32.3% achieved ypT0N0 response, 70.9% ypT≤1N0-x. 12-month EFS was 89.8%. First results suggest potential for immune-chemotherapy in MIBC.

FNIH study in Radiology identifies variations in ultrasound elastography measurements, aiding interpretation of liver disease progression. Findings suggest a 30.7% difference in SWE and 35.6% in VCTE may reflect technical variability, not true changes in liver stiffness, guiding future clinical trials and reducing reliance on liver biopsies.

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FDA approves TREMFYA®, the first dual-acting IL-23 inhibitor for active ulcerative colitis, showing significant endoscopic remission rates in QUASAR program. TREMFYA® is also approved for plaque psoriasis and psoriatic arthritis.