Kv7.4

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

TÜBINGEN, Germany I October 9, 2023 I Acousia Therapeutics, a pioneer clinical-stage biotech company focused on the development of novel drug therapies for the prevention and treatment of acute and chronic forms of hearing loss, received approval from the German regulatory authorities (BfArM) for its groundbreaking Phase 2 clinical trial of the etiology-agnostic otoprotectant ACOU085 in patients with cisplatin-induced hearing loss. Cisplatin-based chemotherapy, a lifeline for countless cancer patients, often delivers an unwanted side effect: irreversible hearing loss, i.e. ototoxicity, which occurs in 60% or more of cancer survivors. This makes the prevention of cisplatin-induced ototoxicity a significant unmet medical need for patients with a large potential market for a new therapeutic regimen. In a recently concluded Phase 1b clinical trial, ACOU085 demonstrated excellent safety and tolerability as well as long local residence time of the proprietary, sustained-release formulation, which is essential for providing extended otoprotection in acute hearing loss conditions such as cisplatin-induced ototoxicity. The Phase 2a multicentric, randomized, placebo-controlled, split-body trial will evaluate the efficacy of ACOU085 for preventing cisplatin-induced ototoxicity in young male patients diagnosed with testicular cancer. The clinical study will assess several efficacy outcomes for ACOU085, including changes in high-frequency, pure-tone audiometry, speech comprehension in quiet and noisy environments, and otoacoustic emissions. The enrolment of the first patients is expected in late 2023. Tim Boelke, CEO and Chief Medical Officer of Acousia, said: "Cisplatin is a lifeline for cancer patients, yet the heartache of hearing loss it brings is devastating. We are thrilled by the swift regulatory approval of our ACOU085 trial, which validates our development approach and offers the promise of hearing protection as patients battle cancer. " 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. For example, the unique dual mode of action of its small-molecule Kv7.4 agonists, the acute functional OHC enhancement, and the sustained OHC protection aim to both enhance and preserve a patient's natural hearing. Acousia Therapeutics develops drugs for both local and systemic administration. SOURCE: Acousia Therapeutics

TÜBINGEN, Germany, Oct. 9, 2023 /PRNewswire/ -- Acousia Therapeutics, a pioneer clinical-stage biotech company focused on the development of novel drug therapies for the prevention and treatment of acute and chronic forms of hearing loss, received approval from the German regulatory authorities (BfArM) for its groundbreaking Phase 2 clinical trial of the etiology-agnostic otoprotectant ACOU085 in patients with cisplatin-induced hearing loss. Cisplatin-based chemotherapy, a lifeline for countless cancer patients, often delivers an unwanted side effect: irreversible hearing loss, i.e. ototoxicity, which occurs in 60% or more of cancer survivors. This makes the prevention of cisplatin-induced ototoxicity a significant unmet medical need for patients with a large potential market for a new therapeutic regimen. In a recently concluded Phase 1b clinical trial, ACOU085 demonstrated excellent safety and tolerability as well as long local residence time of the proprietary, sustained-release formulation, which is essential for providing extended otoprotection in acute hearing loss conditions such as cisplatin-induced ototoxicity. The Phase 2a multicentric, randomized, placebo-controlled, split-body trial will evaluate the efficacy of ACOU085 for preventing cisplatin-induced ototoxicity in young male patients diagnosed with testicular cancer. The clinical study will assess several efficacy outcomes for ACOU085, including changes in high-frequency, pure-tone audiometry, speech comprehension in quiet and noisy environments, and otoacoustic emissions. The enrolment of the first patients is expected in late 2023. Tim Boelke, CEO and Chief Medical Officer of Acousia, said: "Cisplatin is a lifeline for cancer patients, yet the heartache of hearing loss it brings is devastating. We are thrilled by the swift regulatory approval of our ACOU085 trial, which validates our development approach and offers the promise of hearing protection as patients battle cancer." 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. For example, the unique dual mode of action of its small-molecule Kv7.4 agonists, the acute functional OHC enhancement, and the 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] SOURCE Acousia Therapeutics GmbH