Gateway Biotechnology

[AfroSnowman]

The two-year threshold is so out of their ass. At the risk of coming across like a simpleton, it'll either work for tinnitus or it won't. I don't believe this condition has a million and one different etiologies.

Especially at two years out. If they were doing <6 months, I'd understand, but what is the difference between month 20 and month 200? Either way, it is set up for good; neurological pathways have formed and are not going anywhere.

 

[Nick47]

Is it for acute or chronic tinnitus?

This abnormal electrical activity may be the direct result of an increase in calcium channel activity. Recent data from our SBIR direct Phase II grant (R44DC018759) showed that L-type, but not T-type calcium channel blockers are effective in the treatment of tinnitus after acoustic trauma. One such blocker of L-type calcium channels is nimodipine (NMDP), an FDA-approved drug with an extensive record of safety and pharmacokinetic data. In the U.S., an NMDP oral formulation is used to reduce ischemic deficits after subarachnoid hemorrhage, and in Europe, an intravenous formulation is approved for the same indication to increase its delivery to the brain. Using an established animal model for tinnitus induced by noise exposure, we developed a new nasal formulation for NMDP (GW-TT2) to reduce its systemic side effects, increase its brain delivery, and improve patients' experience with the use of this drug. Our hypothesis is that NMDP, when delivered nasally, can be a safe and effective therapy for noise-induced tinnitus.

 

[dd314]

Verapamil is also an L-type calcium channel blocker, and it's a much more commonly used drug than Nimodipine.

A quick search of Reddit yielded 1 improvement and 2 worsenings of tinnitus caused by Verapamil. That makes sense, given that it drops blood pressure, and hypotensive drugs (like Nimodipine, by the way) have been known to cause tinnitus.

 

[ccm302]

I emailed back & forth with Dr. Bao awhile back. He's a nice guy. It seems like he's doing everything he can to push it. I'm hoping with the backing of the Army he can make it happen.

 

[StoneInFocus]

The second one is just listed as a "gene therapy" drug. There are not many details, but I'm just glad to see there are still drugs for tinnitus in their pipeline.

The only thing we know about GW-TT5 is that it is a "novel two-component gene therapy approach" that targets cells in the auditory pathway and that there are "promising" pre-clinical animal studies.

In the Inner Ear Disorders Therapeutics Summit on August 20-22, Tom Brutnell, Chief Operating Officer & Vice President, is going to give a talk titled Exploring Novel Small Molecule & Gene Therapeutic Approaches for Tinnitus Indications for Improved Patient Care. He's going to talk about GW-TT5 then.

I hope GW-TT5 is going to work for tinnitus sufferers without mutated genes, too. I am very curious to know more about it. Will it target cells in the cochlea or in the central nervous system? Will it be administered intravenously or locally, like Dr. Bance did to restore that deaf girl's hearing?

Unfortunately, it is still far away from being tested on humans:

View attachment upload_2024-5-26_15-3-24.png

More information here:

→ GW-TT2, a New Drug Product for Tinnitus

They say they "developed a new nasal formulation for NMDP (GW-TT2) to reduce its systemic side effects, increase its brain delivery, and improve patients' experience with the use of this drug".

Oral Nimodipine barely has any side effects. I am on 8 x 30 mg per day now and don't notice any side effects whatsoever.

Nimodipine is used for cerebral infarction, so in any case, the oral formulation already enters the brain.

View attachment 56900

→ Gateway Biotechnology: GW-TT2

In my opinion, as a tinnitus sufferer, there is no point in waiting that long.

If you think Nimodipine could be a treatment option and you have the balls to try it, I'd say do it.

Maybe people can tell their doctors something about GW-TT2 so he/she is more willing to prescribe Nimodipine?

 

[Nick47]

Based on research, Gateway Biotechnology has received a fair amount of NIH funding. It appears that the most promising candidates from 10+ years of NIH-funded testing and 12+ drug combinations are GW-TT2 and GW-TT5, and Gateway Biotechnology is now focusing on these.

GW-TT2

• The FDA gave them the green light for their 505(b) NDA-approval pathway, which means this candidate is undergoing an accelerated timeline.
• Phase 1 2025.
• The official project end date for the research grant for GW-TT2 is January 17, 2026.
• Nasal formulation.

GW-TT5

• GW-TT5 is a gene therapy targeting cells in the auditory pathway. Its apparently promising preclinical animal studies suggest that it can " manipulate tinnitus symptoms with gene therapy."
• Animal testing in 2026. If found safe, followed by IND.

Genetic subtyping for tinnitus

• There is a new section on the Gateway Biotechnology website that addresses tinnitus subtyping. Specifically, they mention the ability to identify genetic signatures associated with genetic subtypes. GW-TT5 and a new series of objective tests could end up giving patients the knowledge of what tinnitus subtype they have and whether or not a gene therapy (such as GW-TT5 or what may emerge in the future) can impact their tinnitus.
  
  To take it a step further, they add a list of other subtyping tests, such as metabolic profiling in blood samples, which will allow them to define tinnitus subtypes and even non-invasive functional biomarkers related to audiometric data, and EEGs and MRIs, which can allow them to zero in on clinically relevant subtypes of tinnitus that are affecting people.
  
  They now mention the "Gateway solution," which has subtyping and therapies, including small molecule and gene therapy, as the solution.
  
  It emphasizes why there will not be an effective treatment for all or even most tinnitus patients.

 

[StoneInFocus]

There is a new section on the Gateway Biotechnology website that addresses tinnitus subtyping. Specifically, they mention the ability to identify genetic signatures associated with genetic subtypes. GW-TT5 and a new series of objective tests could end up giving patients the knowledge of what tinnitus subtype they have and whether or not a gene therapy (such as GW-TT5 or what may emerge in the future) can impact their tinnitus.

I have looked at that section and have not read that GW-TT5 could be used as a diagnostic tool for different subtypes of tinnitus.

 

[Joeseph Stope]

GW-TT2 is a nasal formulation designed to treat moderate to severe tinnitus that has developed within the last two years (recent-onset tinnitus).

Recent onset tinnitus is the initial indication, but expansion into additional indications is likely.

I think it's important to keep discussing and researching the distinction in tinnitus cases. It seems that many cases where tinnitus completely disappears or where some form of habituation occurs happen within the first three to four months. After that, the chances of healing decrease as time goes on.

If someone were to develop a new treatment for early-onset tinnitus, it would need to prove itself against other treatments, including placebo. I don't have a medical background, but I'm interested in new approaches to tinnitus research. For example, I'm excited about the Australian initiative (the Bionics Institute) to objectively measure the volume of tinnitus.

I think progress might come in small steps, such as finding a way to change the sound of tinnitus to something more pleasant or focusing on the brain rather than just the ear. For example, Susan Shore's research into the brain is a welcome diversion from the focus on the ear.

 

[ccm302]

Oral Nimodipine barely has any side effects. I am on 8 x 30 mg per day now and don't notice any side effects whatsoever.

So, you're already on Nimodipine? Is it helping your tinnitus?

 

[StoneInFocus]

So, you're already on Nimodipine? Is it helping your tinnitus?

Not anymore; I ran out of pills. It's a long story.

Anyway, I do not think Nimodipine helped my tinnitus.

I took Nimodipine for my hyperacusis, though. It only helped a little bit I believe.