Clinical development of AC102 for the treatment of sudden sensorineural hearing loss

 

Introduction To date, there is no approved treatment for sudden sensorineural hearing loss (SSNHL). Glucocorticoids are recommended in the guidelines, but the therapeutic benefit is unclear. AC102, a newly developed molecule, clearly outperformed glucocorticoids in preclinical hearing loss models. In a phase 1 study, AC102 (intratympanic) was proven to be safe and well tolerated. A phase 2 study is currently being conducted to investigate the efficacy of AC102.

Methods AC102-201 is a randomized, blinded, multicenter study. A single intratympanic injection of AC102 will be compared with oral prednisolone, 60mg/day for 14 days. Approximately 210 patients with severe to profound idiopathic SSNHL will be enrolled in up to 50 European study centers within 5 days of the event onset. The improvement in hearing threshold (average of the three most affected consecutive frequencies), speech recognition, possible tinnitus and vertigo as well as quality of life will be evaluated over the observation period of 84 days.

Results The Data Safety Monitoring Board (DSMB) review of the blinded data to date showed an average age of 55 years with a hearing loss of 77 dB. Adverse events to date have included otalgia after injection, hyperglycemia and palpitations.

Discussion The DSMB had no safety concerns and recommended a continuation of the recruitment. So far, the good tolerability of phase I has been confirmed. This study represents a further step towards the development of an SSNHL treatment that may have a relevant benefit for our patients.

Publication History

Article published online:
19 April 2024

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