Hearing loss company Acousia announces first patient enrolled in its Phase 2 PROHEAR-Study

Tübingen, Germany, February 15, 2024

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.