Summary: Berlin-based AudioCure Pharma has surpassed 50% patient enrollment in its Phase 2 trial testing AC102, a novel therapy targeting sensory cells and synaptic connections to treat sudden hearing loss.
Takeaways:
- Enrollment Milestone Achieved: AudioCure Pharma has enrolled over half of the patients needed for its Phase 2 trial of AC102, aiming to address the unmet need for effective sudden hearing loss treatments.
- Mechanism of Action: Unlike corticoid therapies, AC102 specifically targets sensory cells and synaptic connections in the inner ear, showing near-complete hearing restoration in preclinical studies.
- Challenging Recruitment Window: The trial’s success hinges on enrolling patients within days of sudden hearing loss onset, reflecting high interest in more effective treatment options.
Berlin-based start-up AudioCure Pharma has enrolled more than 50% of the planned patients in its ongoing Phase 2 clinical trial. The aim of the study is to test the efficacy of the new compound AC102 for the treatment of sudden hearing loss.
As sudden hearing loss is usually treated with non-specific corticoids that are not approved for this indication or for which there is no clear evidence of efficacy, there is an urgent need for new therapies.
Developing AC102 for Sudden Hearing Loss Treatment
This enrollment milestone is an important step in the development of AC102 and in addressing the unmet medical need for sudden hearing loss. The safety and tolerability of AC102 has already been successfully tested in healthy volunteers.
“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,” says coordinating investigator, Professor Stefan Plontke, PhD, of Martin-Luther-University Halle-Wittenberg. “I am therefore very pleased with this recruitment success, which underscores the high level of interest in new, more effective treatment options for patients with sudden hearing loss.”
How AC102 Works
AC102 is considered a promising alternative to corticoid therapy for sudden hearing loss, as it was able to restore hearing almost completely in an acoustic trauma model after a single application in a preclinical study.(1) This work also revealed the mechanism of action of AC102. Unlike the non-specific, anti-inflammatory effects of corticoids, AC102 specifically targets the sensory cells and synaptic connections in the inner ear that are responsible for hearing loss.
Further Reading
“Our 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,” says Reimar Schlingensiepen, PhD, CEO of AudioCure Pharma.
The Phase 2 trial is expected to continue enrolling patients until end of 2025.
References:
- Rommelspacher H, et al., PNAS. 2024 Apr 9;121(15)
