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The MR-139 3001 Phase 3 trial consisted of a randomized, placebo-controlled, double-masked prospective study, with a total of 477 patients who were randomized to receive either MR-139 or placebo, self-administered to the eyelids twice daily, treated and observed over 12 weeks.
Continuous cardiac monitoring with Vivalink devices following surgical discharge may improve early detection of postoperative arrhythmias, according to researchers at Brigham and Women’s Hospital
These findings were recently published in the prestigious International Journal of Molecular Sciences in a joint study conducted by Erlangen University Hospital and Berlin-based drug developer AudioCure.
At 30 days, there were no deaths, strokes or re-hospitalizations. No patients had vascular complications, PVL (> moderate) or required a permanent pacemaker. Core lab echocardiographic data demonstrated a mean gradient of 6.3 mmHg, and valve area of 2.8 cm2 .
SENS-501, including the surgical delivery of the gene therapy, shows a good safety profile in all patients treated so far. 3 month results from a SENS-501 treated toddler in the first cohort demonstrate early promising hearing improvement. The second cohort assessing a higher dose of SENS-501 is ongoing and recruitment is close to being completed.
This FIH Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and the signs of early efficacy (LDL-C lowing effect, and liver fat quantitative value using MRI-PDFF) of PRD001 in adult healthy volunteers.