TÜBINGEN, GERMANY – Acousia Therapeutics, a clinical-stage biotech company specializing in innovative drug therapies for hearing loss, has obtained regulatory approval from the German regulatory authorities (BfArM) for its Phase 2 clinical trial of the etiology-agnostic otoprotectant ACOU085 in patients with cisplatin-induced hearing loss.
Chemotherapy and Hearing Loss
Cisplatin-based chemotherapy, a vital treatment for many cancer patients, often results in an unfortunate side effect: irreversible hearing loss, or ototoxicity, affecting more than 60% of survivors. This creates a significant unmet medical need for preventing cisplatin-induced ototoxicity, with a substantial potential market for a new therapeutic approach.
In a recently completed Phase 1b clinical trial, ACOU085 demonstrated excellent safety and tolerability. The trial also confirmed the long local residence time of the sustained-release formulation, crucial for extended otoprotection in conditions like cisplatin-induced ototoxicity.
The Phase 2a multicentric, randomized, placebo-controlled, split-body trial will evaluate ACOU085’s effectiveness in preventing cisplatin-induced ototoxicity in young male patients diagnosed with testicular cancer. The study will assess various efficacy outcomes, including changes in high-frequency pure-tone audiometry, speech comprehension in quiet and noisy environments, and otoacoustic emissions. Patient enrollment is anticipated to commence in late 2023.
Tim Boelke, CEO and Chief Medical Officer of Acousia, expressed optimism about the swift regulatory approval, emphasizing the potential for hearing protection as cancer patients undergo cisplatin-based treatment.
“Cisplatin is a lifeline for cancer patients, yet the heartache of hearing loss it brings is devastating. We are thrilled by the swift regulatory approval of our ACOU085 trial, which validates our development approach and offers the promise of hearing protection as patients battle cancer.”
–Tim Boelke, CEO and CMO of Acousia Therapuetics
About Acousia Therapeutics GmbH
Acousia Therapeutics GmbH is a privately-held, clinical stage biotech company based in Tübingen, Germany. The company is dedicated to the identification and development of small molecules for effective prevention and treatment of different etiologies of hearing loss. Acousia Therapeutics develops drugs for local and systemic administration.
Source: Acousia Therapeutics
