Acousia Therapeutics GmbH

TÜBINGEN, Germany, Aug. 12, 2024 /PRNewswire/ -- Acousia Therapeutics GmbH, a Tübingen-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, will be presenting the ACOU085 Phase 2 PROHEAR clinical study at the HansonWade 4th Inner Ear Disorders Therapeutics Summit in Boston (MA) from August 20–22, and at the 36th World Congress of Audiology from September 19–22, 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. Contact Tim Boelke, M.D. [email protected] SOURCE Acousia Therapeutics GmbH

TÜBINGEN, Germany, Feb. 15, 2024 /PRNewswire/ -- Acousia Therapeutics GmbH, a Tübingen-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, just announced the randomization of the first patient for the PROHEAR-Study. The PROHEAR-Study is a placebo-controlled, Phase 2a study with split-body design, which investigates the otoprotective efficacy of ACOU085 in patients with testicular cancer undergoing high-dose cisplatin-based chemotherapy regimens (cis-Pt ≥300 mg/m2). Germ-cell testicular cancer is the most common cancer among young men, with incidence rates continuously increasing. With the introduction of cisplatin as a treatment option in the late 1970s, most men with metastatic testicular cancer are cured, with a 30–60 year life expectancy after treatment. Ototoxicity is a typical and severe 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. While ototoxicity may have been an unavoidable trade-off for a cancer cure to date, clinical hearing loss comes with considerable negative impacts for survivors, including communication problems, heightened fatigue, reduced social interaction, and an increased long-term risk of developing dementia. In preclinical models, ACOU085 has demonstrated its significant potential to reduce cisplatin-induced hearing loss and preserve outer hair cells from ototoxicity. In the double-blind, randomized PROHEAR-Study, patients with testicular cancer receive transtympanic injections of ACOU085 in one ear and a placebo in the contralateral ear prior to each chemotherapy cycle, as such each patient serves as his own control. The PROHEAR-Study is being conducted at major university clinics across Germany and has been formally endorsed by the Study Group of the German Society of Otorhinolaryngology (DSZ-HNO). "The enrollment of the first patient into our ACOU085 Clinical Phase 2 program marks a further major milestone in our efforts to finally make acute and subacute forms of hearing loss treatable" said Dr. Tim Bölke, CEO and CMO of Acousia Therapeutics. About Acousia Therapeutics GmbH Acousia Therapeutics GmbH is a privately held, clinical-stage biotech company based in Tübingen, Germany. The company is dedicated to the identification of small molecules for the effective prevention and treatment of different hearing loss etiologies. Acousia is focused on the development of proprietary drug candidates, which are designed to affect the sensory outer hair cells (OHC) in the cochlea of the inner ear. The unique dual mode of action of its small-molecule Kv7.4 activators combines acute functional OHC enhancement and sustained OHC protection and aims to both enhance and preserve a patient's natural hearing. Acousia Therapeutics develops drugs for both local and systemic administration. Contact Tim Boelke, M.D. [email protected] SOURCE Acousia Therapeutics GmbH

German pioneer biotech accelerates hearing loss solution development with fresh capital boost TÜBINGEN, Germany, Jan. 9, 2024 /PRNewswire/ -- Acousia Therapeutics GmbH, a clinical-stage biotech company developing drug candidates against acute and chronic forms of hearing loss, proudly announces Esperante Ventures as the latest addition to its esteemed group of investors. The infusion of fresh capital is set to boost the progress of Acousia's Kv7.4 activator programs, with a focus on advancing the ongoing clinical development of ACOU085. ACOU085 is a proprietary, small-molecule, etiology-agnostic otoprotective drug candidate, which recently entered Phase 2 clinical testing for the prevention of chemotherapy-induced hearing loss and sensory hair cell death in cancer patients. The significant otoprotective potential of ACOU085 is broadly supported by results from a number of preclinical studies in relevant models. Sustained target exposure by ACOU085 in the cochlea is achieved through local application of a novel, proprietary slow-release gel formulation using standard transtympanic injection. Tim Boelke, CEO of Acousia Therapeutics, said, "Adding Esperante Ventures with their existing position in inner ear therapeutics to our investor syndicate – amidst a challenging macro-economic environment and despite recent drawbacks in competing hearing loss drug development programs – is a testament to the confidence in our unique and proprietary Kv7.4 activator approach. Our lead candidate ACOU085, currently in Clinical Phase 2, aims to set a new standard for treating acute and subacute forms of hearing loss." Dean Slagel, Managing Director of Esperante Ventures, said "We are excited to invest in Acousia's novel and compelling approach to treating the significant unmet indication of chemotherapy-induced hearing loss, supported by its excellent leadership, robust data and experienced investors." About Acousia Therapeutics GmbH Acousia Therapeutics GmbH is a privately held, clinical-stage biotech company based in Tübingen, Germany. The company is dedicated to the identification of small molecules for the effective prevention and treatment of different hearing loss etiologies. Acousia is focused on the development of proprietary drug candidates, which are designed to affect the sensory outer hair cells (OHC) in the cochlea of the inner ear. The unique dual mode of action of its small-molecule Kv7.4 activators combines acute functional OHC enhancement and sustained OHC protection aim to both enhance and preserve a patient's natural hearing. Acousia Therapeutics develops drugs for both local and systemic administration. Contact Tim Boelke, M.D. [email protected] About Esperante Ventures Esperante is a corporate venture capital company and part of a family-controlled global life science group. Its leadership is experienced in the management of life science companies with an emphasis on the development and commercialisation of prescription pharmaceuticals. Its investment focus is mainly from Phase 2 clinical development onwards with a geographical focus in Europe and North America. Further information is available at