Acousia Therapeutics Completes Enrollment in Phase 2 Trial Testing ACOU085 for Cisplatin-Induced Hearing Loss
核心洞察
Acousia Therapeutics (搜索) has completed patient enrollment in the Phase 2 PROHEAR trial evaluating ACOU085 (Bimokalner) for preventing cisplatin-induced hearing loss (搜索) in testicular cancer patients.
The double-blind, split-body trial enrolled young male patients with metastatic testicular cancer (搜索) across 15 German university hospitals to test the first-in-class otoprotective drug.
ACOU085 targets the KCNQ4-encoded Kv7.4 potassium channel (搜索) in outer hair cells (搜索) and has shown potential to preserve cochlear integrity in preclinical models.
Acousia Therapeutics (搜索) has reached full enrollment in its Phase 2 PROHEAR clinical trial (NCT06521190), marking a significant milestone for the company's lead candidate ACOU085 (Bimokalner) in preventing cisplatin-induced hearing loss (搜索). The trial is evaluating the first-in-class otoprotective drug in young male patients with metastatic testicular cancer (搜索) receiving cisplatin-based chemotherapy.
Trial Design and Patient Population
The PROHEAR study is a double-blind, randomized, placebo-controlled, split-body, multicenter Phase 2 trial that recruited participants across 15 university hospitals in Germany. The trial specifically enrolled young patients aged 18 to 45 years with metastatic testicular cancer (搜索) scheduled to receive cisplatin-based chemotherapy.
Patients are randomly assigned to receive either ACOU085 or placebo administered prior to each cisplatin cycle in a split-body design. The study protocol includes comprehensive audiometric testing at baseline and at the completion of each cisplatin cycle to compare functional hearing metrics between treated and untreated ears.
Primary and Secondary Endpoints
The primary endpoint measures the proportion of patients showing a difference of at least 10 dB between ears in at least 2 frequencies for air conduction in pure tone average (PTA) at high frequencies (4, 6, 8 kHz) and extended high frequencies (10, 12, 14, 16 kHz) between baseline and the end of chemotherapeutic cycle 3.
Secondary endpoints include intraindividual differences in distortion product otoacoustic emissions, PTA bone conduction, the Oldenburger Test, and the Freiburger Test.
Mechanism of Action and Clinical Rationale
ACOU085 is described as a first-in-class, etiology-agnostic otoprotective small molecule delivered via standard transtympanic administration in a proprietary slow-release gel formulation. The drug modulates the biologically validated KCNQ4-encoded Kv7.4 potassium channel (搜索) expressed in outer hair cells (搜索) (OHCs).
Cisplatin-induced hearing loss (搜索) represents a significant clinical challenge, as cumulative doses of 300 mg/m² or greater can cause permanent hearing loss in the majority of patients. This severe side effect results from irreversible damage to the cochlea's outer hair cells (搜索). In preclinical models, ACOU085 has demonstrated potential to reduce cisplatin-induced ototoxicity (搜索) by preserving the integrity of these critical cells.
Clinical Significance and Future Timeline
"Today marks an important development milestone for Bimokalner," said Tim Boelke, MD, CEO and CMO of Acousia Therapeutics (搜索). "This drug candidate has the potential to prevent the permanent inner ear damage frequently observed following cisplatin-based chemotherapy. As we reach full enrollment in the PROHEAR study, I want to express gratitude to all participating patients and clinical teams for their trust and commitment."
The PROHEAR trial is designed to provide both translational target validation for Acousia Therapeutics (搜索)' Kv7.4 activator programs and clinical proof of principle for Bimokalner in hearing loss (搜索) patients. According to Boelke, "The blinded preliminary results are promising, and we look forward to reviewing the full unblinded dataset in Q2–Q3 2026."
The completion of enrollment represents a crucial step toward potentially addressing an unmet medical need in oncology, where effective cancer treatment with cisplatin often comes at the cost of permanent hearing impairment.