Otonomy Otividex AVERTS-2 Results for Meniere's

[Aaron123]

Awhile back I posted about the results of Otonomy's AVERTS-1 trial for Meniere's Disease (https://www.tinnitustalk.com/threads/otonomy-otividex-fails-in-phase-3-ménières-trial.23648/). The top-line results of the second Phase 3 trial have been released and are positive. There appears to be a statistically significant reduction in "definitive vertigo days" compared to placebo. I'd like to see the full results because it appears that the sample size drops from baseline to month 3, and it would be interesting to know why. It isn't clear whether there is a similar drop in the AVERTS-1 data.

The top-line results for AVERTS-2 are here http://phx.corporate-ir.net/Externa...9NjgzOTM0fENoaWxkSUQ9MzkzNzcyfFR5cGU9MQ==&t=1
and the press release is here http://investors.otonomy.com/phoenix.zhtml?c=234082&p=irol-newsArticle_Print&ID=2315557.

The results have had a positive effect on Otonomy's stock price so it will see how this affects some of the decisions they made a couple of months ago.

 

[jer]

That is just wonderful news for anybody with Ménière's disease. Well done Otonomy!

 

[acufenero]

From their financial report:

Continued to Advance Multiple Programs for Sensorineural Hearing Loss: Preclinical development continues on multiple programs for the prevention and/or treatment of sensorineural hearing loss including age-related hearing loss. These programs involve the anatomical and functional restoration of ribbon synapses, protection of hair cells from chemotoxicity, and regeneration of hair cells. The company believes that the multiple hearing loss conditions targeted by these programs comprise the largest patient populations and market opportunities in the otology field. The company will provide a more detailed outline of these programs and development timelines in a future investor update.

[...]

Anticipated Upcoming Milestones

[...]

• Complete the pipeline review and prioritization, and present a development plan for multiple clinical and preclinical programs in the first quarter of 2018.

 

[Frédéric]

Wonderful! It's a good piece of news!

But that leads me to ask the question: what were the differences between the protocol of AVERTS-1 and the protocol of AVERTS-2 to obtain such different results? Does anybody know?

 

[Benoves]

Does this mean there is another company on the run for hair cell regenaration?

 

[GregCA]

The top-line results of the second Phase 3 trial have been released and are positive. There appears to be a statistically significant reduction in "definitive vertigo days" compared to placebo.

@glynis - here's some hope!

 

[Aaron123]

Does this mean there is another company on the run for hair cell regenaration?

Otonomy's fourth program OTO-4XX is said to focus on hearing loss including hair cell regeneration (http://www.otonomy.com/pipeline/oto-4xx/), but that is a long way off at this point.

 

[Spiral]

Based on the first article, didn't they suspend their second study?

David A. Weber, Ph.D., president and CEO of Otonomy. 'Based on these results, we are immediately suspending all development activities for OTIVIDEX including the ongoing AVERTS-2 trial.'

 

[Codaz]

Otividex is a steroid they say in the press release. Ok, but so is dexamethason which is nowadays used for Meniere's. What does it do (better)? And does it destroy hair cells further in order to retrieve less vertigo? Does it destroy the vestibular organ like gentamycine?

 

[jeff W]

Otividex is a steroid they say in the press release. Ok, but so is dexamethason which is nowadays used for Meniere's. What does it do (better)? And does it destroy hair cells further in order to retrieve less vertigo? Does it destroy the vestibular organ like gentamycine?

They don't know how steroids work.