That was @Neville’s opinion too. It was like the first quote was almost an outlandish thing to say. That’s FX though. The science might be great for all I know but their relentless self-promotion makes me skeptical.
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correct, It could be the person having a bad day or a good day that could make a different… 10 db is not going to make a different…
I trust the FDA. Don’t you?
They just started the trial for the newer version (FX-345) in Dec. Supposed to penetrate deeper into the cochlea to address lower frequencies. I’d happily take an extra 10 db across the board.
Jordan
But test-retest variability diminishes in importance with enough trial participants and enough tests per participant, right?
Depends on definition of “importance.” 10dB may be statistically significant, ie a “real,” repeatable difference, but 10dB is still not going to make much difference to somebody with a 90dB loss.
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Would you say that someone with an 80dB loss shouldn’t care if they lose another 10dB? That’s logically the same thing.
I don’t know about “not caring,” but I don’t think it’s going to make much difference.
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“In general, as reported by biotech news site Evaluate, the FX-322 trial results have largely been lackluster. In fact, Bloomberg Law reported in summer 2021 that investors have filed suit against the company for making false claims about the clinical trials.”
I figured this would be the case. They never answered my email asking if they were able to treat profound hearing loss yet and what kind of numbers they achieved. No email answers to a detail request is usually a bad sign.
FX changed gears when the audiometry scores were lacklustre. It’s all about word recognition scores now. I haven’t seen an explanation that makes sense to me why minimal changes in thresholds would lead to significant improvement in ‘clarity’. If I were going to have someone inject something into my ear, I’d like to think that they knew why.
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I know some people over at the tinnitus forums got replies- even from Jeffrey Karp himself no less. I don’t think they have the staff to answer every email. Many questions they don’t have the answers to because they’re still trying to find the answers.
If there are no real risks in testing the drug, why not fast track it? Even if it proves lackluster, things will be learned and no one gets hurt but investors. And that comes with the territory.
It is being fast tracked. People do get hurt though, just not in obvious ways. This drug was hyped from day 1 and large numbers of people with severe tinnitus pinned their hopes on it. The hype worked. The founders of FX got very rich- or even richer than they were before. The bad news is that when the multi-dose phase 2 trial crashed, those who were heavily invested in it emotionally took a major psychological hit. Some of them took a financial hit as well because they invested to try to support the company. Source: hundreds of pages on TinnitusTalk forum, watching it all unfold.
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That article was from 2019. Is that still the case?
Of course I’m sympathetic to those who got their hopes up. I’m also a bit…cynical perhaps…about people who uncritically believe the stories told by those with a product or project to sell. The drug was untested. The promises were aspirational. both of those things should alert folks to have hope but not believe a cure is at hand. Hasn’t everyone seen this story a hundred times before? Bitcoin comes to mind. As far as investment money: it happens, a lot, that new research doesn’t pan out, even though it seems promising. Look at fusion power. Scientists continue with it and make slow progress. I wouldn’t invest in it quite yet.
Let me blunt, exactly, if you really want to really fix your hearing, you need replace with with a stable system that can send electrical impulses such as a cochlear implant. The brain does not care and it is a bunch of data cable connected to the brain, your brain can recognize patterns based on your childhood memory…
You’re right. I got my hopes up a little and I was disappointed a little. But there are people out there living on the ragged edge in tinnitus land who bought into it totally. There are dozens of biotechs out there beavering away that you never hear of. They do the science and they either succeed or (mostly) fail. FX led with a story that was coherent and apparently plausible and they used the prestige of their Harvard labs to sell it. They didn’t just have promising new lines of enquiry, they had the answer! Borderline ethics in my opinion.
I have tinnitus too, and have had for many decades. Not as bad as many, which is a blessing. I’d love to see a cure, or even some amelioration. But all my life I’ve only heard that tinnitus is intractable and non curable. Period. So, it would take a lot to get my hopes up. I’m not familiar with FX; sounds like they engaged in border line ethics at least, as you write. Another biotech start up exec was recently sentenced to prison for lying to investors about their product. One hopes this will serve notice.
Frequency Therapeutics’ FX-322 has failed. A very sad day.