Phase 1 Results and Phase 2 Initiation for AC102: A Novel Drug Candidate for the Treatment of Sudden Sensorineural Hearing Loss (SSNHL)

Ronald Pennings, Christoph Arnoldner, Michael Nieratschker, Christin Galetzka, Alena Meis, Rachael Ward, Cris Lanting, Reimar Schlingensiepen

Keywords: Hearing Loss, Pharmacotherapy, Clinical Trial, Phase 1, Phase 2

Background:

Hearing loss is the third most prevalent chronic health condition in adults with proven links to depression and dementia. However, physicians are faced with patients suffering from sudden sensorineural hearing loss (SSNHL) with no approved pharmacotherapy. Clinical practice guidelines recommend the use of corticosteroids for which evidence remains unclear. AC102 is specifically developed for otic indications and outperformed corticosteroids in preclinical hearing loss models.

Research questions:

We present results from a first-in-human study of AC102 with the questions: Is AC102 safe and well tolerated? If so, does it merit further investigation in hearing loss patients?

Method:

AC102 was compared to placebo in 42 healthy volunteers receiving either intratympanic AC102 formulated in a thermosensitive gel at increasing concentrations and volumes or placebo injection. Endpoints at Day 28 were safety and tolerability, including assessment of audiological and vestibular function. Enrolling healthy volunteers with normal hearing ensured any audiological changes measured.

Results:

Treatment emergent adverse events occurred almost equally in both treatment groups. Most were mild and resolved within days. No serious adverse events were observed. The injection hole healed within 1-4 days. In both groups, transient increases in hearing threshold mainly at higher frequencies resolved within 2-4 days after injection. No clinically relevant changes in auditory or vestibular function were observed.

AC102 is now being evaluated in SSNHL patients in a randomized, blinded, two-arm Phase 2 trial. Patients with moderately-severe to profound idiopathic SSNHL are enrolled at ≤50 European sites. Efficacy, safety and tolerability of AC102 will be compared to corticosteroid treatment, giving all patients a treatment option.

Conclusions:

Intratympanic AC102 is safe and well tolerated at all volumes and concentrations examined. AC102 is a promising and innovative therapeutic approach to address a significant, unmet medical need and provide physicians with a treatment with a clinically meaningful benefit to their SSNHL patients.

Points for discussion:

Management of patients with hearing loss at their first appointment

What changes and / or developments would help in the management of hearing loss patients

Considerations before treating hearing loss with corticosteroids

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