Summary:
Acousia Therapeutics has reached 50% enrollment in its Phase 2 ProHear Study testing ACOU085 to prevent cisplatin-induced hearing loss in testicular cancer patients undergoing chemotherapy.

Key Takeaways:

  • Hearing Loss Risk from Cisplatin: Up to 80% of cisplatin-treated patients suffer hearing damage, making hearing preservation a critical unmet need in oncology.
  • Innovative Trial Design: The ProHear Study uses a split-body method where one ear receives ACOU085 and the other a placebo to directly assess efficacy.
  • Active Progress and Recruitment: Conducted across 13 German clinics, the study aims to complete enrollment by late 2025 and represents a major step toward hearing loss prevention in cancer care.

Acousia Therapeutics GmbH announced that it has successfully enrolled 50% of patients in its ongoing Phase 2 clinical trial, the ProHear Study, evaluating ACOU085 (INN: bimokalner) for the prevention of cisplatin-induced hearing loss in patients with testicular cancer undergoing chemotherapy.

Cisplatin is a cornerstone in modern oncology and is used annually in more than 500,000 cancer patients worldwide. Its introduction in the late 1970s revolutionized testicular cancer treatment, improving the 5-year survival rate (from just 5% to 98%). However, its life-saving efficacy is often overshadowed by severe side effects, with permanent, bilateral hearing loss among the most debilitating.

Studies indicate that up to 80% of patients treated with cisplatin may experience clinically relevant hearing loss.

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The ProHear Study is a placebo-controlled, randomized, double-blind, split-body trial in which participants receive ACOU085, a Kv7.4 channel activator, in one ear and a placebo in the contralateral ear.

The study is currently being conducted at 13 leading German ENT university clinics and is still actively recruiting.

“This marks a significant milestone on Acousia’s journey to offer a treatment for the prevention of permanent hearing loss caused by cisplatin,” says Professor Hubert Löwenheim, chair of the Department of Otolaryngology – Head & Neck Surgery at Tuebingen University and scientific supervisor of the study. “Preventing this often overlooked side effect is critical for cancer patients. Notably, all ProHear participants who have received >=300 mg/m² of cisplatin to date have developed ototoxicity. This is higher than reported in most, if not all, previous studies.”

The ProHear Study is on track to complete enrollment by the end of the second half of 2025. For more information, visit https://clinicaltrials.gov. 

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