Acousia Therapeutics

Acousia Therapeutics GmbH is a clinical-stage biotechnology firm, established in 2012, operating from Tübingen, Germany. The company was co-founded by Professor Dr. Hubert Löwenheim of the University of Tuebingen, EMC Microcollections, and the Boehringer Ingelheim Venture Fund (BIVF). Löwenheim, a recognized expert in otolaryngology, provides a deep scientific and clinical foundation for the company's mission, stemming from his extensive research in hearing loss. Acousia is focused on a significant and largely unaddressed market: therapeutic treatments for sensorineural hearing loss (SNHL), which accounts for over 90% of all hearing loss cases.

The company's core business is the discovery and development of small-molecule drugs designed to protect and restore auditory function. This positions Acousia as an alternative and potential complement to existing hearing aids and cochlear implants, which do not restore natural hearing. The business model centers on advancing its drug candidates through clinical trials to eventually secure regulatory approval and commercialization. The primary clients are patients experiencing hearing loss from a variety of causes, including ototoxic drugs, age-related decline, and noise exposure. Acousia has cultivated a strong investor consortium including BIVF, LBBW Venture Capital, Creathor Ventures, Bregua Corporation, KfW, and Esperante Ventures to fund its capital-intensive research and development.

Acousia's lead drug candidate is ACOU085 (bimokalner), a small-molecule Kv7.4 potassium channel agonist. This drug has a dual mode of action: it provides acute enhancement of hearing function while also delivering long-term protection to the sensory outer hair cells (OHCs) in the inner ear. ACOU085 is administered via a transtympanic injection of a proprietary slow-release gel, designed to ensure sustained target engagement in the cochlea. A key focus for ACOU085 is preventing ototoxicity—irreversible hearing damage—a common side effect for cancer patients undergoing cisplatin-based chemotherapy. The company is conducting the PROHEAR study, a Phase 2a clinical trial, to evaluate the drug's efficacy in testicular cancer patients receiving this chemotherapy. The trial, which began enrolling patients in late 2023, uses a split-body design where each patient serves as their own control, receiving the drug in one ear and a placebo in the other. The study reached 50% enrollment as of April 2025 and aims for completion by the end of the second half of 2025.

Keywords: hearing loss therapeutics, sensorineural hearing loss, SNHL treatment, otoprotection, ACOU085, bimokalner, small-molecule drugs, ototoxicity, cisplatin-induced hearing loss, Kv7.4 potassium channel agonist, clinical-stage biotechnology, drug development, University of Tuebingen spin-off, Hubert Löwenheim, inner ear disorders, auditory function restoration, cochlear hair cells, Boehringer Ingelheim Venture Fund, LBBW Venture Capital, Creathor Ventures, PROHEAR study, transtympanic injection, age-related hearing loss