Small cap Auris Medical Holding has missed its co-primary endpoints in a key Phase III trial after it failed to beat placebo in treating patients with tinnitus. The drug, Keyzilen (AM-101), could not best a dummy treatment in creating statistically significant changes in tinnitus loudness and tinnitus burden compared to placebo.
The Swiss biotech was looking to the future, reminding investors that results from a second Phase III trial, TACTT3, are due out this year--with the company hoping for better data. The biotech wants Keyzilen to become the first drug to gain approval for treating acute inner ear tinnitus, but this failure will be a major setback for the company.
The treatment contains esketamine hydrochloride, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, made in the form of a biocompatible and biodegradable gel.
It is given in one treatment cycle, comprising three intratympanic injections over three to 5 days into the middle ear. From there the drug diffuses through the so-called round window membrane into the cochlea.
“We are disappointed that our TACTT2 trial did not reach its co-primary efficacy endpoints. The assessment of the trial data is ongoing and we intend to discuss outcomes and our plans for a path forward with regulatory agencies prior to the readout from the TACTT3 trial,” said Thomas Meyer, founder, chairman and CEO of Auris Medical.
“We would like to sincerely thank all patients, investigators and study site staff participating in TACTT2 for their dedicated contribution to the trial. Acute inner ear tinnitus represents an important unmet medical need and we remain committed to achieving our mission of providing tinnitus patients with effective and safe therapeutic options.”
TACTT3, which is being conducted in Europe, is a randomized, double-blind, placebo-controlled test in acute and post-acute inner ear tinnitus, following traumatic cochlear injury or otitis media.
The trial has enrolled more than 300 patients during the acute tinnitus stage and around 330 patients during the post-acute tinnitus stage. The mark of its success will be if it can produce a change in tinnitus loudness from baseline to day 84.
Analysts at Leerink were downbeat about the news. “These top-line results are disappointing and we are now compelled to anxiously wait for results from the Phase III TACTT3 EU study in 4Q16 as well as the full TACTT2 dataset analysis later this year. Our price target is under review,” the firm said in a note to clients.
It added: “Ultimately it remains to be seen how the FDA/EMA would consider Keyzilen if TACTT3 is successful in light of today's negative TACTT2 results, as we expect that two successful pivotal trials are necessary for approval.”
The company saw its shares down by more than 65% pre-market this morning on the news, with a market cap as of yesterday at just $186 million. It finished the day up 40% yesterday, before the data were released.
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