Summary: 

Acousia Therapeutics GmbH will present the Phase 2 PROHEAR clinical study on ACOU085, an otoprotective drug candidate, at two major conferences, addressing cisplatin-induced hearing loss in patients with testicular cancer.

Key Takeaways:

  1. PROHEAR Study Focus: The Phase 2 study investigates the efficacy of ACOU085 in protecting against hearing loss caused by high-dose cisplatin chemotherapy in testicular cancer patients.
  2. International Presentations: The study will be presented at the 4th Inner Ear Disorders Therapeutics Summit in Boston and the 36th World Congress of Audiology in Paris.
  3. ACOU085 Mechanism: ACOU085 targets the Kv7.4 potassium channel in outer hair cells to reduce hearing loss, demonstrating potential in preclinical models.

Acousia Therapeutics GmbH, a Tübingen, Germany-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, will be presenting the ACOU085 Phase 2 PROHEAR clinical study on hearing treatment for patients undergoing chemo with cisplatin at the HansonWade 4th Inner Ear Disorders Therapeutics Summit in Boston, Mass., August 20–22, and at the 36th World Congress of Audiology September 19–22, 2024.

Further reading: Acousia Therapeutics’ Clinical Trial to Address Hearing Loss from Cisplatin

PROHEAR Study

The PROHEAR study is a placebo-controlled Phase 2a study with split-body design investigating the otoprotective efficacy of ACOU085 in patients with testicular cancer undergoing high-dose, cisplatin-based chemotherapy regimens (cis-Pt ≥300 mg/m2). Formally endorsed by the Study Group of the German Society of Otorhinolaryngology (DSZ-HNO), the PROHEAR study is being conducted across major university clinics in Germany under a CTA granted by the German Federal Institute for Drugs and Medical Devices (BfArM) and European Medicines Agency (EMA).

Inner Ear Disorders Therapeutics Summit

On August 21, Jonas Dyhrfjeld-Johnsen, PhD, will be presenting the Phase 2 PROHEAR clinical study on ACOU085 at the industry-leading 4th Inner Ear Disorders Therapeutics Summit organized by HansonWade in Boston in the Discovering & Validating Brand-New Drug Targets for Noise-Induced, Age-Related & Chemically-Induced Deafness session. In addition, Dyhrfjeld-Johnsen will be chairing the Summit and participating in roundtable and panel discussions.

World Congress of Audiology

On September 22, Dr. Dyhrfjeld-Johnsen will be presenting the Phase 2 PROHEAR clinical study of ACOU085 to an international audience of clinical specialists at the 36th World Congress of Audiology in Paris, France during the Clinical Trials in Audiology and Otoneurology session.

PROHEAR Study Interest

“We are thrilled by the invitations to present our ongoing PROHEAR study testing the otoprotective efficacy of ACOU085 against cisplatin-induced hearing loss to the international clinical community and our industry peers. The great interest in our clinical development program is a reflection of the major unmet medical need and long-lasting health consequences facing patients suffering acute forms of hearing loss, such as the side effects induced by life-saving chemotherapy,” says Dyhrfjeld-Johnsen, CDO and managing director of Acousia Therapeutics.

About ACOU085

ACOU085 is a small-molecule, etiology-agnostic otoprotective drug candidate delivered using standard, transtympanic administration of a proprietary, slow-release gel formulation. Ototoxic hearing loss is a typical, severe, and permanent 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 (OHCs). ACOU085 modulates a biologically validated target, the KCNQ4-encoded Kv7.4 potassium channel of the OHCs and has demonstrated significant potential to reduce cisplatin-induced hearing loss and preserve outer hair cells from ototoxicity in preclinical models.

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