Acousia Therapeutics to present its clinical Phase 2 PROHEAR study on hearing loss treatment candidate ACOU085 at upcoming conferences

Tübingen, Germany, August 12, 2024

The PROHEAR study is a placebo-controlled Phase 2a study with split-body design investigating the otoprotective efficacy of ACOU085 in patients with testicular cancer undergoing high-dose, cisplatin-based chemotherapy regimens (cis-Pt ≥300 mg/m²). Formally endorsed by the Study Group of the German Society of Otorhinolaryngology (DSZ-HNO), the PROHEAR study is being conducted across major university clinics in Germany under a CTA granted by the German Federal Institute for Drugs and Medical Devices (BfArM) and European Medicines Agency (EMA).

On August 21, Dr. Jonas Dyhrfjeld-Johnsen will be presenting the Phase 2 PROHEAR clinical study on ACOU085 at the industry-leading 4th Inner Ear Disorders Therapeutics Summit organized by HansonWade in Boston (MA) in the Discovering & Validating Brand-New Drug Targets For Noise-Induced, Age-Related & Chemically-Induced Deafness session. In addition, Dr. Dyhrfjeld-Johnsen will be chairing the Summit and participating in roundtable and panel discussions.

On September 22, Dr. Dyhrfjeld-Johnsen will be presenting the Phase 2 PROHEAR clinical study of ACOU085 to an international audience of clinical specialists at the 36th World Congress of Audiology in Paris, France during the Clinical Trials in Audiology and Otoneurology session.

“We are thrilled by the invitations to present our ongoing PROHEAR study testing the otoprotective efficacy of ACOU085 against cisplatin-induced hearing loss to the international clinical community and our industry peers. The great interest in our clinical development program is a reflection of the major unmet medical need and long-lasting health consequences facing patients suffering acute forms of hearing loss, such as the side effects induced by life-saving chemotherapy” said Dr. Jonas Dyhrfjeld-Johnsen, CDO and Managing Director of Acousia Therapeutics. 

ACOU085 (INN: Bimokalner) is a first-in-class, small-molecule, etiology-agnostic otoprotective drug candidate delivered using standard, transtympanic administration of a proprietary, slow-release gel formulation. Ototoxic hearing loss is a typical, severe, and permanent side effect of cisplatin treatment and is a consequence of irreversible damage to the sensory cells in the inner ear, the so-called outer hair cells (OHCs). ACOU085 modulates a biologically validated target, the KCNQ4-encoded Kv7.4 potassium channel of the OHCs and has demonstrated significant potential to reduce cisplatin-induced hearing loss and preserve outer hair cells from ototoxicity in preclinical models.