A high dose of glucocorticoid steroids is no more effective than the standard dose for sudden hearing loss but is associated with more side effects. This has been shown by a recent clinical study with over 300 sudden hearing loss patients led by the internationally renowned ENT specialist Prof. Dr. Stefan Plontke from the University Medicine Halle. It is estimated that several hundred thousand people worldwide suffer every year from sudden sensorineural hearing loss, a specific form of sudden hearing loss, every year. As the trend is increasing and there is currently no approved and demonstrably effective treatment for this condition, the medical need for new therapies is very high.
Sudden hearing loss can be caused by several factors, many of which are unknown. In the worst cases, sensory cells and synapses in the inner ear die permanently. On the assumption that inflammation plays a role in sudden hearing loss, it is usually treated with anti-inflammatory glucocorticoids. These drugs are not approved for the treatment of sudden hearing loss, and it is unclear whether and at what dosages they are effective for this condition. The new study shows no additional benefit for high doses of glucocorticoids, but more severe side effects. However, even with the standard dose, around 60 percent of patients did not experience complete recovery. “These drugs have been used around 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 Plontke. According to the specialist, there is an increasing need for new drug treatment options for sudden hearing loss.
A next-generation drug for sudden hearing loss is being developed by the Berlin-based company AudioCure Pharma. In hearing loss models, the new compound AC102 outperforms the effect of glucocorticoids, likely because it targets the affected sensory cells and synapses more specifically. “We are not surprised by the results of the study. Glucocorticoids as anti-inflammatory drugs are a good treatment option for many conditions. There is no convincing mode of action for the treatment of sudden hearing loss with steroids, as our own research results also has shown,” says Dr. Reimar Schlingensiepen, CEO of AudioCure Pharma. A first clinical trial on healthy volunteers has already successfully evaluated AC102 for safety and tolerability. A clinical study with AC102 is currently underway at over 30 sites in Europe, investigating its efficacy in the treatment of sudden hearing loss compared to glucocorticoids.
Study: Plontke SK, Girndt M, Meisner C, et al. High-Dose Glucocorticoids for the Treatment of Sudden Hearing Loss. NEJM Evid 2024;3(1) DOI: 10.1056/EVIDoa2300172