AM-111 failed to meet its primary endpoint, although the company is putting a positive spin on it by noting it was effective in a subpopulation.
Auris Medical Holding released its third-quarter financial report and provided a clinical update. Part of the clinical update was that its HEALOS Phase III clinical trial of AM-111 for acute inner ear hearing loss failed to meet its primary endpoint, although the company is putting a positive spin on it by noting it was effective in a subpopulation. Investors, however, weren’t impressed, and company stock dropped dramatically.
“The read-out from the HEALOS Phase III trial with AM-111 in acute inner ear hearing loss is a major milestone for Auris,” said Thomas Meyer, Auris’ founder, chairman and chief executive officer, in a statement. “Although the trial did not meet our expectations on the primary efficacy endpoint in the overall study population, we are very pleased to see the statistically and clinically significant treatment effects in the profound hearing loss subpopulation. Considering the high unmet medical need, we look forward to discussing the regulatory pathway for AM-111 with the regulatory agencies. In addition, we continue to focus on the development of Keyzilen for acute inner ear tinnitus, with top-line Phase III results expected in early 2018, and AM-125 for vertigo, which is preparing for Phase I.”
The Phase III TACTT3 trial for Keyzilen for tinnitus completed enrollment, with 741 patients in Europe. The company expects to announce top-line results in the first quarter of 2018.
On the business front, the company arranged share purchase agreements with Lincoln Park Capital Fund for up to $15 million, which would provide some operational flexibility. Thomas Jung, the company’s chief development officer, is leaving the company at the end of the year. And the company reported cash and cash equivalents as of Sept. 30, 2017, of CHF 20.2 million. Total operating expenses for the quarter were CHF 5.6 million, down from CHF 7.5 million for the same period the year before. Research and development expenses for the quarter were CHF 4.2 million, down from CHF 6.3 million for the third quarter of 2016. Net loss for the quarter was CHF 6 million, or CHF 0.14 per share.
Reuters noted, “Auris Medical’s rival Otonomy Inc said on Monday it would stop commercialization of ear infection drug Otiprio, sending its shares up 14.8 percent to $6.20 in premarket trading on Tuesday. Otonomy said it planned to focus on developing other drugs in its pipeline, including the marketing application for its Meniere’s disease drug in the United States.”
Auris’ shares fell 49 percent after today’s announcement, currently trading at $0.42 per share. Auris indicates that of the two studies, ASSENT and HEALOS, it plans to terminate ASSENT. The two trials have similar design. The company indicated that based on the recent findings, ASSENT is no longer adequate for testing the drug AM-111.
Back in February 2017, the FDA had granted AM-111 Fast Track status, which had caused stock to pop by 13 percent. AM-111 is a biodegradable gel administered by injection into the middle ear through the ear drum. The drug diffuses through the round window membrane into the cochlea, where its active ingredient, a synthetic peptide, D-JNK-1, inhibits the JNK stress kinase. Inhibiting JNK is believed to protect stress-injured cochlear cells and lead to the prevention or reduction of hearing loss.
