Acousia Therapeutics GmbH, a clinical stage biotech company based in Tübingen, Germany, has announced the randomization of the first patient for the PROHEAR-Study on February 15, 2024. This is a major milestone in the company’s efforts to enhance and preserve natural hearing.
The PROHEAR-Study is a placebo-controlled, Phase 2a study with a split-body design. It will investigate the otoprotective efficacy of ACOU085 in patients with testicular cancer undergoing high-dose cisplatin-based chemotherapy regimens. Testicular cancer is the most common cancer among young men and its incidence rates are continuously increasing. While cisplatin has been an effective treatment option since the late 1970s, it also has severe side effects, including ototoxicity, which is irreversible damage to the sensory cells in the inner ear.
According to Dr. Tim Bölke, CEO and CMO of Acousia Therapeutics, “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.” The company’s drug candidate, ACOU085, has shown promise in preclinical models for reducing cisplatin-induced hearing loss and preserving outer hair cells from ototoxicity.
In the PROHEAR-Study, patients with testicular cancer will receive transtympanic injections of ACOU085 in one ear and a placebo in the other ear prior to each chemotherapy cycle. This will allow each patient to serve 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. Bölke also stated that the enrollment of the first patient in the ACOU085 Clinical Phase 2 program is a major step towards making acute and subacute forms of hearing loss treatable. Acousia Therapeutics is dedicated to the identification of small molecules for the prevention and treatment of various hearing loss etiologies. Their drug candidates are designed to affect the sensory outer hair cells in the cochlea of the inner ear, with a unique dual mode of action for both acute functional enhancement and sustained protection.
For more information about Acousia Therapeutics GmbH and their drug development, please visit their website at www.acousia.com. Contact information for Dr. Tim Bölke, M.D., can also be found on the website.
Derick is an experienced reporter having held multiple senior roles for large publishers across Europe. Specialist subjects include small business and financial emerging markets.