Hearing loss company Acousia announces first patient enrolled in its Phase 2 PROHEAR-Study
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).
Tübingen, Germany
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.
boelke@acousia.com
www.acousia.com
About news aktuell GmbH
news aktuell, a subsidiary of the Deutsche Presse-Agentur (dpa), provides companies, institutions and associations with effective access to both the media and consumers and supports the organizations in telling their stories easily and successfully. Utilizing the digital tools “ots” and “zimpel” PR content reaches all media formats, including classic print titles, wide-reach online portals or social networks. In addition, news aktuell publishes all of its clients' PR content on www.presseportal.de, one of Germany's widest-reaching PR portals. Thus, all relevant multipliers are reached worldwide, ranging from editors and digital influencers to specialist bloggers and interested consumers. Communications specialists from all over Germany rely on the expertise of the dpa subsidiary. news aktuell has been on the market since 1989 and employs over 135 people. The company is based in Hamburg. Further locations include Berlin, Frankfurt and Munich.
Subscribe to releases from news aktuell GmbH
Subscribe to all the latest releases from news aktuell GmbH by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from news aktuell GmbH
Vyoma’s first Space Domain Awareness satellite has reached orbit13.1.2026 13:42:00 CET | Press release
Munich, 13. January 2026 - Vyoma, a Germany-based company providing Space Domain Awareness (SDA) capabilities, has launched its pioneering surveillance satellite, Flamingo-1, on Sunday, January 11th, 2026 from Vandenberg Space Force Base, California, USA. It was launched aboard the Twilight rideshare mission with SpaceX via Germany-based launch integrator Exolaunch. The satellite was deployed to its operational Sun-synchronous orbit of approximately 500-km in altitude. This marks a significant achievement for the company, which patented the operational concept of an optimized SDA mission. Flamingo-1, equipped with an optical sensor for space-based space surveillance, is a gamechanger for Europe, strengthening SDA efforts directly from orbit. The advanced optical instrument will detect, track and characterize space objects, such as debris and other satellites. Crucially, it will allow Vyoma and its customers to follow up on manoeuvring objects and derive insights into adversary actions
ORTEC expands German healthcare footprint with strategic acquisition of Klages & Partner13.1.2026 09:00:00 CET | Press release
Acquisition adds over 200 healthcare customers and sector-specific workforce management expertise to ORTEC’s portfolio
Acousia Announces Completion of Patient Enrollment in Phase 2 PROHEAR Study Evaluating ACOU085 (INN: Bimokalner) for the Prevention of Cisplatin-Induced Ototoxicity8.1.2026 09:00:00 CET | Press release
Tübingen, Germany, January 8, 2026 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
Dr. Stefanie Kesting appointed as CEO of Thyssengas7.1.2026 14:06:26 CET | Press release
Dortmund, 06.01.2026 As of January 1, 2026, Dr. Stefanie Kesting has been appointed as the new Chief Executive Officer (CEO) of Thyssengas GmbH. She succeeds Dr. Thomas Gößmann, who will retire at the end of February 2026 after nearly nine years at the helm of the company. The leadership transition was announced in autumn 2025.
30 Years of European Spas: Nature, Natural Remedies and Climate Health as Europe’s Unique Strength7.1.2026 08:59:31 CET | Press release
To mark its 30th anniversary, the European Spas Association (ESPA) has released a special commemorative publication highlighting the strategic role of Europe’s medical spas and climate-health resorts in an era defined by prevention, longevity and sustainable wellbeing.
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom