AudioCure Pharma is advancing the clinical development of AC102, a novel compound for the treatment of sudden hearing loss, with its Phase 2 trial now over 50% enrolled. This milestone marks significant progress in addressing the unmet medical need for effective therapies for this condition, which currently relies on non-specific corticoids with limited proven efficacy.
AC102: A Targeted Approach to Hearing Restoration
Unlike traditional corticoid treatments, AC102 is designed to specifically target the sensory cells and synaptic connections within the inner ear that are crucial for hearing. Preclinical studies have demonstrated its potential to restore hearing, showing near-complete recovery in an acoustic trauma model following a single application. These findings, published in PNAS, highlight AC102's unique mechanism of action and its potential to offer a more effective treatment option.
According to Dr. Reimar Schlingensiepen, CEO of AudioCure Pharma, the goal is to achieve a paradigm shift in the treatment of sudden hearing loss with the specific effect of AC102 and to contribute to better help sudden hearing loss patients in the future.
Clinical Trial Details and Recruitment Challenges
The ongoing Phase 2 trial is being conducted across seven European countries and aims to evaluate the efficacy of AC102 in patients experiencing sudden hearing loss. The trial's design presents unique challenges, as patients must be enrolled within a narrow window of a few days following the onset of hearing loss to maximize the potential benefit of the compound. Despite these challenges, the trial has successfully enrolled over half of the planned participants, underscoring the high level of interest in new treatment options.
Professor Stefan Plontke of Martin-Luther-University Halle-Wittenberg, the coordinating investigator, noted that recruitment for the trial is challenging because the compound can only be effective in the first few days after the onset of the sudden hearing loss and we can therefore only enroll patients in the study during this short window. He expressed his satisfaction with the recruitment success, which underscores the high level of interest in new, more effective treatment options for patients with sudden hearing loss.
Supporting Research and Future Directions
Research led by MedUni Vienna has further elucidated the potential of AC102, demonstrating its ability to protect inner ear cells and auditory nerves from inflammation-related damage. A study published in Cell Death & Disease showed that AC102 administration led to increased recovery of residual hearing in animal models with cochlear implants, suggesting its potential to mitigate hearing loss associated with surgical procedures. These findings support the ongoing clinical development of AC102 as a promising therapy for sudden hearing loss, with the Phase 2 trial expected to continue enrolling patients until the end of 2025.
