The Phase II trial will test ACOU085 in preventing hearing loss in testicular cancer patients undergoing cisplatin chemotherapy. Credit: Bangkoker / Shutterstock.com.

German company Acousia Therapeutics has enrolled the first patient in a Phase II clinical trial for its investigational otoprotective drug candidate, ACOU085, targeting cisplatin-induced hearing loss in testicular cancer patients.

The trial received approval from the German Federal Institute for Drugs and Medical Devices (BfArM) in October last year, marking a significant step forward in addressing this severe chemotherapy side effect.

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It employs a double-blind, randomised, placebo-controlled, split-body design to evaluate ACOU085’s ability to protect hearing.

In the PROHEAR-Study, testicular cancer patients undergoing high-dose cisplatin-based chemotherapy regimens will receive transtympanic injections of the drug in one ear and a placebo in the other before each chemotherapy cycle, effectively using each patient as their own control.

The study is being carried out in collaboration with university clinics throughout Germany and has received formal support from the German Society of Otorhinolaryngology’s Study Group (DSZ-HNO).

Preclinical models have shown that ACOU085 has the potential to significantly reduce hearing loss caused by cisplatin and protect the outer hair cells in the inner ear from ototoxic damage.

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Ototoxicity is a common side effect of cisplatin, a chemotherapy agent used to treat germ-cell testicular cancer, leading to irreversible damage to the sensory cells of the inner ear.

The negative impacts of clinical hearing loss on cancer survivors are profound, including difficulties in communication, increased fatigue, diminished social interaction, and a higher long-term risk of dementia.

By addressing this side effect, the trial could significantly improve the quality of life for survivors.

Acousia Therapeutics CEO and CMO Dr Tim Bölke said: “The enrolment of the first patient into our ACOU085 Clinical Phase II programme marks a further major milestone in our efforts to finally make acute and subacute forms of hearing loss treatable.”

Earlier this year, the company has received investment from a new investor Esperante Ventures. The capital infusion is intended at advancing the Kv7.4 activator programmes of the company, including the clinical development of ACOU085.