Dr. Meyer said he has been involved in researching tinnitus-targeted drug therapy since 2003, when he first launched Auris Medical. During that time, he noted, he has learned that selectivity is one of the keys to successful drug development. In the case of tinnitus, “you not only have to target the right type or etiology, where you fully understand the biology; you also have to be very specific regarding the type of patient you’re treating. For us, our clinical data suggest that patients in the early stages of the disorder—up to three months out, possibly more—will respond best to our approach.”
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June 2015Dr. Meyer said he is optimistic that a phase 3 trial of acute tinnitus launched in the United States in February 2014, known as TACTT2, will replicate the positive findings of previous trials.
Another Mechanism, Another Hearing Disorder
Auris Medical also has several clinical trials in the works in the United States and Europe that focus on sudden and surgery-induced hearing loss. The drug being evaluated, AM-111, is a stress kinase inhibitor peptide known as D-JNKI-1 that is formulated in a biocompatible and biodegradable gel. By acting on that kinase, AM-111 prevents apoptosis in hair cells and also attenuates the damaging effects of cellular inflammation following acute inner ear injury (Hear Res. 2007;226:168-177).
In a phase 2 clinical trial of AM-111, patients with severe to profound sensorineural hearing loss (PTA thresholds > 60dB) who were treated with 0.4 mg/mL of the drug showed an absolute improvement in hearing loss to day seven of the study (29.9 dB vs. 17.9 dB for place-treated patients; P=0.017) (Otol Neurotol. 2014;35:1317-1326). The drug was well tolerated, with no negative impact on hearing, balance, or tinnitus.
Dr. Meyer said he is excited by the prospect of seeing the first drugs specifically developed for inner ear therapy moving towards broad clinical use. “If all goes well, there will be FDA drugs approved for intratympanic treatments in a few years from now,” he said. “That could have quite an impact on the field of otology.”
Hinrich Staecker, MD, PhD, a professor of otolaryngology and head and neck surgery at the University of Kansas Medical Center in Kansas City, has participated in all three clinical trials involving AM-101. Although “we’re not long enough out” on the phase 3 study, “based on what we’ve seen with prior patients, the prospects for this drug therapy are very promising,” he said.