Great stuff but we need a neurobiologist or biochemist to decipher this, i.e., give us more of an explanation than the "big picture." Lamenting my liberal arts education once again, I wonder is this the first drug designed to work on BDNF? Many animal studies of tinnitus do talk about the relationship between BDNF and the development of tinnitus. Mainly, I believe, researchers argue a breakdown or deficiency in BDNF may cause tinnitus to develop. Preexisting stressors or psychological illnesses, moreover, help deplete BDNF. (I'm in over my head here.)
Another thing about AM-101 is its designation to treat all forms of tinnitus: acute, sub-acute, and chronic. That's wonderful, for the clinical studies thus far have only been for acute suffers. But it is reasonable to assert that since other modalities (e.g., hearing aids) can suppress tinnitus in chronic suffers, then drug therapy should not be limited to acute injuries to the auditory system.
I think in a patent application they don't necessarily need to declare the mechanism(or compound) of action, especially if it's a trade secret still. What they do need to declare is how it will work, though. (I work in intellectual property for a large transgenics company).
My guess is that AM-101 may have therapeutic benefit for chronic tinnitus, or at least they think it might. I'm speculating the reason they are recruiting people only for the acute stage tinnitus in their trials is that they feel it's the best window to prove that their proposed mechanism works. It may have an effect in chronic stage tinnitus that they suspect, but they probably want to make sure this thing is concrete and get it to market for a specific purpose at first. Then, they may investigate it's therapeutic benefits in later clinical trials for chronic tinnitus. If it's safety low safety profile and pretty decent tolerability, it may even be approved for use in chronic cases without further clinical trials. Of course, that's all speculation though.
The markings in the sand all point to a good outlook for this compound though. It's going to be hitting Phase 3 trials in July, and this patent application was dated for November of last year. Auris is no Pfizer, they're risking their venture capital on this. If it wasn't showing decent results in testing, they would probably have abandoned it by now. I hope the best for this compound. If it works and hits the market, these people are going to make a killing. That'll bring a lot more companies to the table (you can bet).
It looks like Auris is going to be presenting about their Phase IIb clinical trials at the TRI conference in May. I'd like to see detailed results and hear what their outlook is on that.
http://www.tinnitusresearch.org/en/meetings/files2013/TRI2013_scientific program_27032013.pdf
**EDIT
"As the inventors have found out, such substances are particularly suitable for the treatment of tinnitus, such as acute, subacute, and/or chronic tinnitus, and phantom pain. U 0126, MEK1/2 inhibitor and PD 98058, an MEK1 inhibitor, can be purchased from Cell Signalling Technology, Inc., Beverly, Mass., United States of America. In this connection, the choice of the concentration employed is up to a person skilled in the art and depends on the severity of the disease, the remaining therapeutic policy, and various individual factors from the patient to be treated. With this background, the concentration employed will be established for the particular individual case by a person skilled in the art using routine measures."
It seems that may be where Auris is getting their compound from. The purpose of this patent application is to patent the proposed pathway, not necessarily the compound. Because it looks like they're getting the compound from a third party. They're just using it in a novel way.
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It's easy to get so lost (confused) in the details......
