Acousia, a company specializing in hearing loss, enrolls first patient in Phase 2 of PROHEAR study

February 15, 2024

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Tübingen-based biotech company, Acousia Therapeutics GmbH, has announced the randomization of the first patient for their PROHEAR-Study on February 15, 2024. The study, which is a placebo-controlled, Phase 2a trial with a split-body design, aims to investigate the otoprotective efficacy of ACOU085 in patients with testicular cancer undergoing high-dose cisplatin-based chemotherapy regimens.

According to the company, germ-cell testicular cancer is the most common cancer among young men and its incidence rates are continuously increasing. While the introduction of cisplatin as a treatment option in the late 1970s has resulted in a high cure rate, it also comes with severe side effects, including ototoxicity. This is a consequence of irreversible damage to the sensory cells in the inner ear, known as outer hair cells. As a result, patients often experience hearing loss, which can negatively impact their quality of life.

ACOU085 has shown promising results in preclinical models as a potential solution to reduce cisplatin-induced hearing loss and preserve outer hair cells from ototoxicity. In the PROHEAR-Study, patients will receive transtympanic injections of ACOU085 in one ear and a placebo in the other prior to each chemotherapy cycle, with each patient serving as their own control. The study is being conducted at major university clinics across Germany and has been endorsed by the Study Group of the German Society of Otorhinolaryngology (DSZ-HNO).

Dr. Tim Bölke, CEO and CMO of Acousia Therapeutics, expressed his enthusiasm for the enrollment of the first patient in the ACOU085 Clinical Phase 2 program, calling it a major milestone in their efforts to make acute and subacute forms of hearing loss treatable.

Acousia Therapeutics GmbH is a privately held, clinical-stage biotech company located in Tübingen, Germany. The company is dedicated to identifying small molecules for the prevention and treatment of various hearing loss causes. Their focus is on developing proprietary drug candidates that target the sensory outer hair cells in the inner ear. The company’s unique dual mode of action combines acute functional outer hair cell enhancement and sustained protection, with the goal of preserving a patient’s natural hearing. They develop drugs for both local and systemic administration.

For more information, please contact:

Tim Boelke, M.D.

boelke@acousia.com