CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

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.

The study finds that CHAI (Computational Histology AI) biomarkers stratify recurrence and progression outcomes independently and outperform current guideline-based risk stratification

The study, titled “Augmented reality system for MRI-guided interventions: a cadaver study”, demonstrates the system’s potential to enhance MRI-guided needle procedures by improving procedural feasibility and reducing the need for repeated imaging scans.

The Phase 2a study EXIST (EXIdavnemab Synucleinopathy Trial), is a randomized, double-blinded, placebo-controlled study to evaluate the safety and tolerability of exidavnemab and its pharmacokinetic profile.

The results of the study, Otitis Treatment with OtoSight™ – Modification of Antibiotic Treatment Intervention in Children (OTO-MATIC), have been published via open access in the International Journal of Pediatric Otorhinolaryngology.