Otonomy Starting Phase 1 Trial in 2015 for Tinnitus

[Casper]

Where did you see thing? According to Otonomy's website (http://www.otonomy.com/about-us/executive-team/), the CEO was a CEO at a couple of eye-focused companies prior to his current job. No mention that he is or has been a hedgefund manager.

I think @NatureHiker was referring to the chairman and co-founder, Jay Lichter. Please correct me if I'm wrong.

Taken from this link (emphasis mine):
"In 2008, Jay Lichter, Ph.D., a partner at Avalon Ventures and biotechnology industry veteran, experienced his first severe attack of vertigo. While driving, he became severely disoriented and had to pull to the side of the road. After multiple doctor visits, he was diagnosed with Ménière's disease and quickly experienced the limitations of available treatments. With his physician, Jeffrey Harris, M.D., Ph.D., chief of the division of otolaryngology-head and neck surgery at the University of California, San Diego, and several other experts in the field of otology, Dr. Lichter founded Otonomy to bring new treatment options to patients with otic (ear) disorders."

 

[NatureHiker]

My bad not a hedge fund manager just a investor/CEO/chair board member/whatever is the correct business phraseology.

I do know that he's suffered from Tinnitus for a while even before he was diagnosed with menieres.

http://www.sandiegouniontribune.com...ul-route-to-starting-2013apr21-htmlstory.html

 

[RODRIGO]

So I understand this is the first farmaceutical trial to improve the chronic tinnitus target in the last years...

 

[AliceW]

Is this treatment given for chronic tinnitus ?(more than 6months ?Am101 was only for recent tinnitus )
Not for recent one ? Are you sure ?
I wrote to this company I would like to try it in the phase 2 of clinical trials... But I'm french and I don't know if they can include me.... And they answered me that they didn't know yet what criteria of tinnitus include for the study... (Sorry for my approximated english)

 

[Dave111]

Is this treatment given for chronic tinnitus ?(more than 6months ?Am101 was only for recent tinnitus )
Not for recent one ? Are you sure ?
I wrote to this company I would like to try it in the phase 2 of clinical trials... But I'm french and I don't know if they can include me.... And they answered me that they didn't know yet what criteria of tinnitus include for the study... (Sorry for my approximated english)

This trial is for everybody with T.

 

[Dave111]

OTO-311 = Gacyclidine

AM-101 = S-Ketamine (Esketamine)

 

[Michael Larsen]

OTO-311 is a so-called NMDA receptor antagonist - though differentiated from AM-101
Esketamine is a "non-competitive NMDA antagonist" whereas Gacyclidine is one
"Un-competitive blocker NMDA antagonist". They therefore have both the same pharmacological target, but work in a slightly different way.

We must therefore assume that both AM-101 and OTO-311 are geared towards
Acute inner ear tinnitus

 

[Mentos]

Does anyome know if OTO-311 clinical trials will be run only in USA or in Europe as well?

 

[Samir]

Does anyome know if OTO-311 clinical trials will be run only in USA or in Europe as well?

I don't know, but I would expect them to.

They have been trialing OTO-104 in GB, BE, DE and US. They have trialed OTO-201 in the US and CA.

Hopefully, for OTO-311 they will at least do a remote trial in GB. I would hope so! Even though I would probably not be able to benefit from it. They should do it across a few places in Europe.

 

[Samir]

This is what I got from Dean Hakanson, MD, Chief Medical Officer at Otonomy Inc.:

"Thank you for your inquiry regarding Otonomy's clinical trials for our tinnitus product candidate, OTO-311. The FDA has cleared the company's Investigational New Drug application (IND) for OTO-311. The IND clearance enables Otonomy to initiate a Phase 1 dose escalation clinical safety trial of OTO-311 in a small number of volunteers who do not have tinnitus. Timing for initiating a Phase 2 trial for OTO-311 in patients with tinnitus is scheduled for the end of this year. We do not have any other details regarding the protocol that can be shared as of todays date."