Following a phase 3 setback a few weeks ago which caused cuts to staff and R&D programs, Otonomy has come back with a positive late-stage trial for its favored candidate Otividex in Meniere’s disease. Last month, Otividex was essentially put on pause after it did not display any activity in patients with Meniere’s, a weary inner ear disorder that affects balance and results in vertigo, tinnitus and hearing loss.
Currently, a second phase 3 trial, which has mostly been completed, is waiting for data. The data has resulted in an unexpected win and a big surge in the company’s share price. The company is now looking to meet with the FDA to talk about a possible filing for the drug, which is a new formulation of the steroid dexamethasone.
As of now, there are no FDA-approved treatments for Meniere’s disease, however, more than 600,000 patients in the U.S have been diagnosed with this specific condition. Otonomy President and CEO Dave Weber commented on the new data, “The new data clearly demonstrates the treatment benefit that Otividex provides by the significantly reducing the number of definitive vertigo days experienced by patients.”
Recently, there have been attempts to conserve capital. This has been shown through a one-third cut in the non-commercial workforce and a deferral in several clinical trials, continue but will be examined again in accordance with the new data. A new plan is expected in the next few months. The current trial, named AVERTS-2, involved 174 patients from six European countries who got a single injection of Otividex into their inner ear and followed the same type of protocol and treatment as the negative U.S trial AVERTS-1. Otonomy is now attempting to explain why the results of the two studies came out different.
The results showed that patients had around nine definitive days of experiencing vertigo, with at least one episode lasting 20 minutes, in the prior four-week period. Otividex decreased that by an average of 6.2 days after three months, which compared to a 2.5-day reduction in the placebo group and was a statistically significant difference.
Over the next three-month period, the otividex displayed a continued improvement. At the same time, the placebo response stayed constant. Chief Scientific Officer Kathie Bishop commented on the results, “We expect to provide a program update in the first quarter of 2018, and that will include the outline of our plan to complete the clinical development of Otividex to file the NDA.” If Autonomy is able to get Otividex back on track, it will be able to give the company resources and confidence to bring about other future projects, including a group of preclinical programs for hearing loss. This will need to happen, as sales of its only marketed dug Otiprio continues to underperform. Otonomy believes that Otiprio will gain momentum if it can obtain an FDA approval for acute otitis in 2018.