Tübingen, Germany – Acousia Therapeutics GmbH announced it has reached the 50% enrollment milestone in its ongoing Phase 2 clinical trial, known as the PROHEAR Study. The trial is evaluating ACOU085 (INN: bimokalner), a Kv7.4 channel activator, for the prevention of cisplatin-induced hearing loss in patients with testicular cancer undergoing chemotherapy.
Cisplatin is widely used in modern oncology, with more than 500,000 patients treated annually worldwide. While it has significantly improved survival rates in testicular cancer—raising the 5-year survival rate from 5% to 98%—its therapeutic benefits are often accompanied by severe side effects, including permanent bilateral hearing loss. Research suggests up to 80% of patients treated with cisplatin may experience clinically relevant hearing impairment.
PROHEAR Study
The PROHEAR Study is a placebo-controlled, randomized, double-blind, split-body trial. Participants receive ACOU085 in one ear and a placebo in the other. The study is being conducted at 13 ENT university clinics across Germany and continues to recruit patients.
“This marks a significant milestone on Acousia’s journey to offer a treatment for the prevention of permanent hearing loss caused by cisplatin,” said 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.”
Enrollment is expected to be completed by the second half of 2025. Further details are available at clinicaltrials.gov.
About ACOU085 (bimokalner)
ACOU085 is a first-in-class, small-molecule drug candidate designed to protect against hearing loss caused by cisplatin. It is delivered via transtympanic injection using a proprietary, slow-release gel formulation. The drug targets the Kv7.4 potassium channel, encoded by the KCNQ4 gene, located in the outer hair cells of the inner ear. Preclinical models have shown that ACOU085 has the potential to reduce cisplatin-induced hearing loss and preserve sensory cells affected by ototoxicity.
Source: Acousia Therapeutics
