#Germany #Acousia Therapeutics #PROHEAR Study #ACOU085 #Tübingen

Acousia Therapeutics Reaches Milestone in PROHEAR Study

Acousia Therapeutics GmbH has recently announced a noteworthy achievement in its ongoing clinical trial, the PROHEAR Study, aimed at preventing hearing loss induced by cisplatin in cancer patients. The company has successfully enrolled 50% of the patients needed for this crucial Phase 2 trial, a significant step forward in their research efforts.

Cisplatin, a chemotherapy drug, has been a cornerstone in cancer treatment since the 1970s, particularly for testicular cancer. It has dramatically improved survival rates, increasing the five-year survival rate from a mere 5% to an impressive 98%. However, while cisplatin is effective in combating cancer, its severe side effects, including permanent bilateral hearing loss, present a daunting challenge for many patients. Research indicates that up to 80% of patients treated with cisplatin may face clinically significant hearing impairment.

The PROHEAR Study is designed as a placebo-controlled, randomized, double-blind, split-body trial. In this innovative design, participants will receive ACOU085, a Kv7.4 channel activator, in one ear, while a placebo will be administered in the contralateral ear. Conducted at 13 leading ear, nose, and throat (ENT) university clinics across Germany, the study is still in the recruitment phase and aims to address an important gap in cancer treatment by providing a safeguard against ototoxicity.

Professor Hubert Löwenheim, the Chair of the Department of Otolaryngology at Tuebingen University and the scientific supervisor of the study, emphasized the importance of this momentous milestone. He stated, “Preventing this often overlooked side effect is critical for cancer patients. Notably, all PROHEAR participants who have received ≥300 mg/m² of cisplatin so far have developed ototoxicity, a figure that exceeds reports from most prior studies.”

The study is projected to complete patient enrollment by the end of the second half of 2025. ACOU085, the drug candidate being evaluated, is a pioneering small-molecule therapy delivered through a unique slow-release gel formulation via standard transtympanic administration. Previous preclinical models have shown its potential to significantly mitigate hearing loss and protect outer hair cells from the damaging effects of cisplatin treatment.

As the trial progresses, Acousia Therapeutics remains committed to addressing this critical aspect of care for cancer patients undergoing cisplatin therapy. The importance of preserving hearing in these patients cannot be overstated, and the ongoing research is a testament to the ingenuity and perseverance of the team behind the PROHEAR Study. For further details on the study and its progress, interested parties can visit clinicaltrials.gov, where updates will be provided as they unfold.

In conclusion, the PROHEAR Study not only marks a significant stride for Acousia Therapeutics in its quest to develop innovative treatments but also offers hope for thousands of patients facing the harsh realities of cancer treatment and its side effects. The journey to prevent hearing loss linked to vital cancer therapies is one that could redefine how such patients experience recovery, thus enhancing their quality of life post-treatment.