Tübingen, Germany (OTE) – Acousia Therapeutics GmbH, a clinical-stage
biotechnology company
developing treatments for acute and chronic inner ear hearing loss,
announced the completion of patient enrollment in its Phase 2 PROHEAR
clinical study. ACOU085 (INN: Bimokalner) is a proprietary, first-in-
class small molecule that has demonstrated robust and reproducible
efficacy across multiple preclinical hearing loss models, including
drug-induced ototoxicity.
The PROHEAR Study is a double-blind, randomized, placebo-
controlled, split-body, multicenter Phase 2 trial. It enrolled young
male patients with metastatic testicular cancer who are scheduled to
receive cisplatin-based chemotherapy. While cisplatin is a highly
effective chemotherapeutic agent, cumulative doses of ≥300 mg/m² lead
to clinically meaningful, permanent hearing loss in the majority of
patients.
Fifteen leading university hospitals in Germany are participating
in this interdisciplinary study. Patients are randomized to receive
either ACOU085 or placebo administered prior to each cisplatin cycle
in a split-body trial design, with a battery of audiometric tests
performed at baseline and at the end of each cisplatin cycle.
Primary Objective
The PROHEAR Study aims to assess whether Bimokalner can prevent
ototoxic hearing loss induced by cisplatin. The study uses within-
patient, placebo-controlled comparisons of functional hearing metrics
and is designed to provide translational target validation for
Acousia Therapeutics’ Kv7.4 activator programs and clinical proof of
principle for Bimokalner in hearing loss patients.
Management Commentary
“Today marks an important development milestone for Bimokalner,”
said Tim Boelke, M.D., CEO & CMO of Acousia Therapeutics. “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 blinded preliminary results are promising,
and we look forward to reviewing the full unblinded dataset in Q2–Q3
2026.”
Tim Boelke (CEO & CMO) and Jonas Dyhrfjeld-Johnsen (CSO & CDO)
will attend JPM Week in San Francisco (January 12–15, 2026) and
welcome the opportunity to engage with investors and strategic
partners during the Biotech Showcase (company presentation: Tuesday,
January 13, 2:15 PM PT) and BIO Partnering @ JPM Week.
About ACOU085 (Bimokalner)
ACOU085 is a first-in-class, etiology-agnostic otoprotective
small molecule delivered via standard transtympanic administration in
a proprietary slow-release gel formulation. Cisplatin-induced hearing
loss is a severe and permanent side effect resulting from
irreversible damage to the cochlea’s outer hair cells (OHCs). ACOU085
modulates the biologically validated KCNQ4-encoded Kv7.4 potassium
channel expressed in OHCs and has shown significant potential to
reduce cisplatin-induced hearing loss and preserve OHC integrity in
preclinical models.
Digital press kit: http://www.ots.at/pressemappe/DE161203/aom
