Reformulated Retigabine (Trobalt): BHV-7000, a Kv7.2 Modulator by Biohaven (Pfizer)

In the last Xenon Pharmaceuticals conference call they named BHV-7000 a direct competitor for XEN1101.

BHV-7000 is a reformulated, more potent version of Trobalt/Retigabine.

Pfizer acquired Biohaven which brings big pharma to this development space.

BHV-7000 is currently in Phase 1 but is expecting to launch a Phase 2 and Phase 3 in parallel next year to launch simultaneously with Xenon Pharmaceuticals' XEN1101. Seems like a first to market competition. Xenon Pharmaceuticals mentioned in their call last week that the Phase 3 will be hopefully shorter than the Phase 2 trial that lasted 2.5 years.

Biohaven actually has a compassionate use program which Xenon Pharmaceuticals does not have.

Biohaven Sets New Course Following Pfizer Acquisition:

Vlad Coric charts course for new Biohaven with neuroscience push and Big Pharma vets on board:

 

Very interesting and exciting news, thanks for this!

The press release states that "Biohaven’s primary focus will be developing treatments for neurological and rare disorders including epilepsy, pain and mood disorders, obsessive-compulsive disorder, spinocerebellar ataxia and spinal muscular atrophy."

I wonder if tinnitus is on their radar?

 

I wonder if an email to the CEO highlighting the success of Trobalt on tinnitus would increase the likelihood of them conducting a small trial for tinnitus alongside their other indications.

 

Good. One thing I was afraid of was Xenon Pharmaceuticals jacking up their prices due to having total market domination. This is the biggest, in my opinion, most scientifically-backed "cure" that we have coming our way.

They definitely know about tinnitus. Pfizer loves profits. We are definitely on their radar.

 

They have a compassionate use program for BHV-7000. They are studying it for pain. I think a lot of people with noxacusis might be able to access it through the compassionate use program.

 

Before it was transformed into BHV-7000 by Biohaven, it was named KB-3061 from Knopp Biosciences: Knopp’s preclinical Kv7 platform is directed to small molecule treatments for neonatal epileptic encephalopathy, other rare epilepsies, tinnitus, and neuropathic pain

They are well aware of the tinnitus potential. They are all awaiting an objective tinnitus test in my opinion before trialing.

 

Bigger and more scientifically backed than Dr. Susan Shore and colleagues?

 

I read they are starting with 250 million, so I'd wager so.

 

So BHV-7000 is in pre-clinical stage? When are the human clinical trials expected to start?

 

I don't mean how much money they have, just that they have shown no interest in tinnitus. No study, no findings and no trials.

Pfizer are even bigger but no use to us currently.

 

The word "compassionate" & the word "tinnitus" = low mutual information value.

 

Fantastic news. Let's see how its side effects compare to other potassium channel openers such as cannabidiol, XEN1101 and RL-81.

Kv7.2/7.3 channel openers for the treatment of tinnitus are way, way more scientifically sound than Dr. Shore's Auricle device, which is basically glorified acupuncture from what I read of it (please correct me if I'm wrong). A Kv.7.2/3 channel opener has been proven to help prevent the emergence of tinnitus in mice after noise exposure.

By the way, in the title it says that BHV-7000 is a Kv7.2 opener, but according to the website, "BHV-7000 is a potent activator of Kv7.2 [and] Kv7.3."

 

It is common knowledge that CEOs take business decisions based on mails by random people.

 

How is this beneficial for tinnitus sufferers?

(Please excuse my lack of knowledge in this field).

 

Dr. Susan Shore's research supports the fact of the DCN going haywire in tinnitus generation.

 

I think you misunderstood if you think Dr. Shore's device is glorified acupuncture. 20 years of scientific research and successful double-blind, sham-controlled trials doesn't lead to acupuncture. Best thing would be to read the thread. You give some good advice in other threads but I plead you to look into this more.

There is nothing more than a hypothesis (although a very reasoned one based on Retigabine) that this BVH-7000 would be helpful. The animal studies look like they are tested on 'acute' conditions only.

Might it work? Look, who knows. Deep down, given the tinnitus market, I always find it difficult to believe - if they thought it would help with tinnitus symptoms - they wouldn't be in trial for that indication.

Yes, I see your point regarding email. I was 'shooting' from the hip.

 

20 years of research doesn't change the fact that is is just electrical pulses that stimulate nerves (not unlike acupuncture) combined with sounds. Appears to me like an experimental treatment with little theory to back its efficacy up. Haven''t seen a single paper describing why or how that is supposed to work for tinnitus. But again I haven't really looked into it too deeply. You could be right. It's foolish to argue about this anyway. And if it works for tinnitus sufferers I'm glad for them, I would definitely try it out too but I don't think it is available in my area yet.

EDIT:

I want to take this back, I just haven't investigated this subject enough to say anything sensible about it. Dr. Susan Shore's method just sounds an awful lot like that treatment in South Korea, and we all know how that went down. But this thread isn't about that anyway.

 

I haven't really followed the Kv7 modulator threads so apologies if this has been discussed already, but is there any possibility that these classes of drugs could help with hyperacusis?

 

Yes since it's also used for pain.

 

Is there a chance they would prescribe BHV-7000 for compassionate use? I'd rather do this than Retigabine.

 

There have been numerous, although anecdotal reports, of complete suppression of noxacusis/loudness hyperacusis with Retigabine, which doesn't target the exact potassium channels we need and is less potent than both of these medications. I'd say there's a very good chance they will help.

@Nick47, most people who were massively helped by Retigabine (@Danny Boy, etc) have had tinnitus for months/years before trying it. Albeit the side effects were disastrous. Based on the results of the XEN1101's side effects after the trials, I can say that the side effects aren't bad at all/minimal.

 

If XEN1101 and BHV-7000 are targeting Kv 7.2 and 7.3, how much of use will they be? There was a map of the auditory network posted here by you, which states that Kv3.1 channels are much more important to modulate at the inferior colliculus (IC) level.

 

When will the first phase of the clinical trial be published?

 

I've asked Biohaven if it is considering a BHV-7000 trial for people with tinnitus. This is the company's answer:

 

The IC is insignificant/superficial in the generation of tinnitus compared to the DCN, at least in the research papers I have reviewed.

 

Is this a no? I can't get an answer from them. I need it now.

EDIT:

I spoke to the VP, Investor Relations at Biohaven Pharmaceuticals today. Very nice lady. I told her how much the tinnitus community is interested in BHV-7000. I'm hoping she speaks to the higher ups about trialing it for tinnitus. She said she would. I hope it at least gets out there for compassionate use for epilepsy or something. I told her I'd invest $115k just to try it now.

 

Invest that in fundamental research instead, like Hyperacusis Research.

 

I've already donated to Hyperacusis Research.

I was making up that I had $115k. I'd sell my house to get better though.

Do you think they would already offer compassionate use for BHV-7000 for epilepsy? Or any other condition? Or is it still in the developmental phase? I wish I had asked her that.

 

If you're that desperate, why not just give cannabidiol isolate a shot?

For less than a hundred bucks you can get very pure powder.

It acts on the same potassium channels and the risks are relatively well known. Just make sure to actually get CBD isolate powder, not any full spectrum oil.

MOD EDIT: Further discussion on cannabidiol isolate should be placed in the thread @StoneInFocus linked above, thanks!

 

There was a publication today about BHV-7000 on Seeking Alpha (an investor platform). They are expecting a pivotal trial (Phase 3 or Phase 2/3) to take place in H2 2023. Seems a very aggressive approach. Maybe we are lucky and their patient recruitment is also very aggressive and fast. Did anyone reach out on the compassionate use program yet? If so, I'd recommend pain with tinnitus as the reason, not tinnitus alone.