AUDIOCURE-PHARMA-GMBH

High-dose glucocorticoids are no more effective than the standard-dose in treating patients with sudden hearing loss. They are also associated with more side effects and significantly worse outcomes for speech recognition and tinnitus perception. Additionally, 60% of patients treated with the standard dose had not fully recovered by the end of the study. This clinical study, led by Prof. Stefan Plontke from the University Medicine Halle, evaluated the efficacy of different doses of glucocorticoids in over 300 sudden hearing loss patients and is published in NEJM Evidence. These results raise the possibility that glucocorticoids may not be sufficiently effective in treating this condition.

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Sudden hearing loss can drastically impair speech understanding and affect a patient’s daily life. Glucocorticoids are prescribed worldwide as the standard-of-care. However, in certain circumstances their side effects can be severe, and it remains unclear whether they provide meaningful improvement for patients. "These drugs have been used globally for 50 years as the standard of care for sudden hearing loss, still there is no reliable scientific evidence for this practice.", explains study leader Stefan Plontke, underscoring the increasing need for new treatments. Many companies are exploring alternatives. However, there is currently only one clinical trial with a new active substance in which patients can participate: The compound AC102 outperformed the widely used cortisone-like dexamethasone in preclinical models of hearing loss, likely because it specifically targets damaged sensory cells and the auditory nerve. Clinical trials are now testing whether this effect is comparable in humans. "We are not surprised by the HODOKORT study results. Glucocorticoids as anti-inflammatory drugs are a good treatment option for many conditions. However, there is no convincing mode-of-action for the treatment of sudden hearing loss with steroids, as our own research has shown," says Dr. Reimar Schlingensiepen, CEO of AudioCure Pharma.

After 50 years of treating sudden hearing loss with glucocorticoids, a new and effective drug for this condition would represent a much-needed paradigm shift.

Original Study: Plontke, et al. NEJM Evid 2024;3(1) DOI:10.1056/EVIDoa2300172

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