Otonomy Starting Phase 1 Trial in 2015 for Tinnitus

Not Sure if this was already posted.
but i dont think so... since its pretty new.
http://globenewswire.com/news-relea...al-Results-and-Provides-Corporate-Update.html

 

Hmm, just stumbled over a previous study where they injected Gacyclidine (OTO-311) into the ear:

Effects of extracochlear gacyclidine perfusion on tinnitus in humans: a case series.

It's somewhat older (05/2010) and only a small number of people participated.

 

Looks like the recent failure of AM-101 in the first Phase III trial has the potential to affect OTO-311. They have been following AM-101 and will wait on the results of TACTT 3 before making a decision about whether to move forward or not with OTO-311. This is from an interview with the CEO of Otonomy:

"Does this Auris news impact your plans at Otonomy?

With tinnitus, our program is in phase 1. Our strategy was to follow Auris — utilize their data to our advantage, and use their investor dollars to do our proof of concept work for that program. We didn’t feel we needed to rush out into phase 2. Instead, we were planning to evaluate their data and determine how to move forward with our OTO-311 program. That's still the plan. We’re waiting on their second phase 3 trial, see their outcome, and then we will make a determination about our program.

Is the tinnitus drug you’re developing is similar to Auris’s compound, then?

Our drug has the same target — we both are NMDA receptor antagonists. Our drug’s different, though. It’s more potent on a molecule-to-molecule basis for the target receptor. It also has a more specific target profile. But we have the same general mechanism of action, which is why we’re watching their data.

Clearly there’s a relationship, because it’s the same target receptor we’re going after, so if the data would indicate there’s absolutely no effect, then we’ll have to evaluate our options. There are a lot of possibilities around what went wrong, so that’s where we need to wait, and evaluate the results.

So what do you think went awry with Auris’s clinical trial?

We don’t know yet whether or not the failure of their trial was based on issues with the endpoints, issues with the patient population, with their clinical trial design, with their dosage… any number of things could have impacted the outcome of the study."

 

Source of this interview?

 

http://us11.campaign-archive2.com/?u=f8609630ae206654824f897b6&id=072d002c61

 

Otonomy (OTIC) held an event this past Friday with a focus on their OTIPRIO medication that has now hit the market. However, the presentation included an update on both OTO-311 (an NMDA-receptor antagonist for the treatment of acute tinnitus - presumably) and also their secretive OTO-4xx pipeline:

• OTO-311 (Gacyclidine): see slides 44-5.
• OTO-4xx: see slides 46 (and onwards).

For OTO-311, it is specifically mentioned that the AM-101 trial will be monitored before making a decision about phase-II. It is also "openly speculated" what could be the cause behind the inability to demonstrate efficacy in the phase-III trial of AM-101 (see below). Full presentation attached.

 

Otonomy is considered a serious company? After reading the slide above, I 'm confused.
They don't trust the way that the AM-101 trial was conducted but they will trial (or not trial) their drug based on AM-101's incoclusive and possibly mistaken research.
Am I understanding this incorrectly?

 

Is the tinnitus drug you’re developing is similar to Auris’s compound, then?

Our drug has the same target — we both are NMDA receptor antagonists. Our drug’s different, though. It’s more potent on a molecule-to-molecule basis for the target receptor. It also has a more specific target profile. But we have the same general mechanism of action, which is why we’re watching their data.

Clearly there’s a relationship, because it’s the same target receptor we’re going after, so if the data would indicate there’s absolutely no effect, then we’ll have to evaluate our options. There are a lot of possibilities around what went wrong, so that’s where we need to wait, and evaluate the results.

 

Poop this smells bad

 

A lot of the problem could be related to the window of opportunity for AM101; that is, its very small.

 

Looks like it's something for "hidden hearing loss" if I'm not misunderstanding the slides.

 

Yeah Oto-4xx is for hidden hearing loss. But do we have any idea if that's in the pipeline? When will it go through trials?

 

No timelines were given, but they do consider it the most attractive market financially. I would say many years to come if the product is still in development

 

To me the NMDA antagonist theory is a bit dull. It washed out after AM-101 was so little effective.
I really believed the theory behind it but in fact treating the ear instead of the brain now sounds quite dull.

 

I attended the conference call hosted by Otonomy on November 3rd. The call lasted roughly 50 minutes. Attached is the presentation from that event.

Main points:

• Otonomy has made positive market launch with OTIPRIO i.e. there are ENTs out there actually buying the product. This is pretty important for an early stage pharma company as it secures them revenue streams that helps solidify the company's existence
• The CEO of Otonomy (Mr. Weber) indicated they are still optimistic about OTO-311 saying that the problems experienced with the similar NMDA-antagonist receptor approach by Auris Medical (Esketamine) are probably more related to clinical trial design than perhaps the science itself. Their current phase-I trial of OTO-311 will continue into 2017.
• There is also some (a little) info on OTO-4xx (restoration of hearing loss via various models).

 

@attheedgeofscience said "probably more related to clinical trial design". That sounds to me like they don't expect that their drug will work for most people with tinnitus but that they are hoping to find one small subgroup that it might have some benefit for. Any idea what subgroup? I hope it's not, for example, just people who have had tinnitus for less than 2 months. I mean, that would be great and all but it still leaves most of the people on this board without any nearish term hope for a medical cure.

 

Any update on oto-311 or oto-4xxx ??

 

http://www.nasdaq.com/press-release...p-morgan-healthcare-conference-20170103-00220

SAN DIEGO, Jan. 03, 2017 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that David A. Weber, Ph.D., president and chief executive officer, will present at the 35th Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2017 at 9:30 a.m. PT at the Westin St. Francis Hotel in San Francisco.

A live audio webcast of the presentation and breakout question and answer session will be available through the Events and Presentations page of the company's website (www.otonomy.com).

About Otonomy

Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO® (ciprofloxacin otic suspension) is approved in the United States for use during tympanostomy tube placement surgery in pediatric patients, and commercial launch commenced in March 2016. OTO-104 is a steroid in development for the treatment of Ménière's disease and other severe balance and hearing disorders. Two Phase 3 trials in Ménière's disease patients are underway, with results expected during the second half of 2017. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that is in a Phase 1 clinical safety trial. Otonomy's proprietary formulation technology utilizes a thermosensitive gel and drug microparticles to enable single dose treatment by a physician. For additional information please visit www.otonomy.com.

Contacts:
Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Senior Vice President
619.849.5377
heidi@canalecomm.com

Investor Inquiries
Westwicke PartnersRobert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com

 

No, come back here and ask again in 15 years.

 

Ok I just got a phone call from Otonomy, Dr Dean Hakanson 1(619)323-2207. He said there isn't going to be a clinical trial for OTO-311 this year, and he told me he had no idea when they are going to start, he was very clear they are waiting for the AM-101 results, is no more to say, that is tinnitus and hyperacusis, no hope.

 

Sounds like a profoundly optimistic conversation you had there.

 

Yeah sadly yes.

 

https://globenewswire.com/news-rele...al-Results-and-Provides-Corporate-Update.html

Initiation of a Phase 2 clinical trial for OTO-311 for the treatment of tinnitus in the second half of 2017. ?

 

Yes, Phase II still planned for second half of 2017.

http://www.otonomy.com/pipeline/oto-311/

 

This sounds nice! Will be work for chronic tinnitus?

 

OTO-311


OTO-311 is a sustained-exposure formulation of the N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine in development for the treatment of tinnitus.

 

So anothet potential treatment. Improving

 

CEO of this company is a billionaire hedgefund manager that had menieres and still has Tinnitus so I feel inspired by this company.

 

It's always better when someone is working on something which can improve his own life.

I'm really excited that there will be soon a phase II but it's weird that they can't tell us :
"during phase I someone with (chronic or not) tinnitus cured".

I feel more confident with Hair Cells Regeneration than with this method used by the past by Auris.

But who knows, maybe it will work, and if it doesn't we still have more chance with FX and Audion

 

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.