A very interesting paper was released not too long ago. It shows that administrating blood plasma of young rats reverses aging in older rats! The doctor you mentioned seems to be very enthusiastic about it.
Well at the very least it sounds like there is some optimism on the ground. I know these local test workers aren't in on the inner workings of the company but it's still nice to hear.
Probably many hope that it will, but let's see. Unfortunately it is not listed as an outcome measure in the phase 2a trial. Maybe if FX-322 shows efficacy in this trial they will include hopefully also loudness/pain hyperacusis sufferers in follow up trials.
The general consensus is that we really don't know. It may be more beneficial for loudness hyperacusis than pain hyperacusis but even then we won't know until further trials are carried out.
Gosh I really hope they get to phase 3. I would totally get in. Only thing is they better change the dB loss to go up to all frequencies. As of right now I just barely miss the dB loss need to have at least 26dB up to 8000 Hz. So I would not make it in right now. Just to think two years from now some of us might be in phase 3, pretty exciting times!!!
If it gets that far I really hope they go for compassionate/expanded use.
I really hope that's the case. If every patient in this trial improves their hearing by a lot due to getting the four doses of FX-322, it seems it could potentially be possible for them to skip and go to Phase 3 once Phase 2a is done or even releasing it into the market during Phase 3.
For what it's worth...
I want this thing to be released as much as you do. But please, let them make sure that this product is 100% safe* and efficacious. We don't want this research to regress because of mistakes or because they've rushed things.
Ideally what we'd want to see among a similar cohort in word score is something along the lines of:
If it does end up improving by that much they really need to release it ASAP. I'm hoping somehow the FDA gives Frequency Therapeutics permission to release the drug early whether that's skipping phases or releasing it during Phase 3 trials.
Right things have changed now they are doing multiply doses so safety might be a concern here.
More of a risk too! Wishing the best for everyone in the study and all the scientists
They might not need a new formulation just a better delivery. If that is what you mean? I have very high frequency loss in one ear. I feel like this treatment would help that but my 3-4 kHz loss this drug would not touch. Anyone have an idea, can they change the delivery method during the trial or do they have to start a new one?
Agree. Because I read that some minute change to the cochlear could mean deafness. And also, some other hair cell regeneration drugs could even kill (in mice)!
That's what they are testing now. If the four doses of FX-322 causes patients to have no side effects and show major improvement in hearing and getting rid of tinnitus and hyperacusis then there's a very good chance for FX-322 getting Breakthrough Therapy status and it might be able to skip phases or release the drug during Phase 3 trials.
Yes it is possible. But it should be opened up for Early Access, which is technically possible but it's up to Frequency Therapeutics or Astellas. Not sure whom will decide. Of course, you still need to start up a big process in order to get the access which takes a lot of time and effort. You need a Doctor who basically states that they can't treat you any further and whom is willing to give you the experimental drugs.
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