AfroSnowman
Member
- Jul 23, 2019
- 1,074
- Tinnitus Since
- 04/2019
- Cause of Tinnitus
- Nonnatural energy source
I may be missing something; why would recruitment be easier for Phase 3?Not necessarily going to be longer. One thing that is believed to be happening is the Phase 2a trial might be determining whether FX-322 shows good enough results after 90 days to demonstrate appropriate benefit or whether they need to go the full 7 months.
Therefore there is a reasonable likelihood that this will make Phase 3 shorter if they only need to wait 90 days to show results, even if the results are better after 7 months. Not to mention there won't be the delays in Phase 3 around things like recruiting and coronavirus which pushed this trial out further.
Do you think that there is any possibility that FX-322 will be available outside of the USA before it's actually available here in the United States?I was looking for the end of Phase 2a since I couldn't find it in the last pages. So just in case, sharing it here again: summer 2021 at best. Will Phase 3 last even longer? I guess so... in that case no treatment would be available for everyone in the US before 2023-24.
- The Phase 2a day-90 readout will assess all efficacy and safety endpoints following single or multiple doses of FX-322, or placebo.
Source: Frequency Therapeutics Announces Expanded FX-322 Clinical Development Program and Upcoming Day-90 Phase 2a Analysis - Frequency Therapeutics (frequencytx.com)
- FX-322 Phase 2a study of patients with mild to moderately severe acquired SNHL (ages 18-65): The Phase 2a study completed enrollment with 95 patients in September 2020. The Company today announced plans to provide a complete analysis of day-90 Phase 2a study data, which is anticipated late in Q1 2021. The Phase 2a end-of-study (seven month) readout is anticipated late in Q2 2021.
Yes it regrows both.Is the consensus that FX-322 regrows both the OHCs and the IHCs or just OHCs?
From Carl LeBel at Frequency Therapeutics: Both OHC and IHC are regrown.Is the consensus that FX-322 regrows both the OHCs and the IHCs or just OHCs?
Phase 4 does not exist.I may be missing something; why would recruitment be easier for Phase 3?
By the way would there be any Phase 4 to expect?
Why recruiting for Phase 3 may be more "efficient":I may be missing something; why would recruitment be easier for Phase 3?
By the way would there be any Phase 4 to expect?
I'm sure there will be a Phase 4, but it's a post approval monitoring study so it won't affect the wait.By the way would there be any Phase 4 to expect?
Do you think it's possible we will know something about a potential Phase 2 or Phase 3 study outside of US from Astellas during 2021?Why recruiting for Phase 3 may be more "efficient":
1. Greater patient/doctor population awareness of FX-322 due of positive Phase 2A results. May be via the news media and/or Frequency Therapeutics communication with doctors/patients, or other general comms methods.
2. US & International Trial Sites providing access to a larger population. The FDA may allow for more sites for the Phase 3 in the US. Astellas has agreed to run Phase 3 clinical trial sites in EU / ASIA / Others.
3. Phase 2A results will include Safety Data. If patients and doctors feel the drug is safe; more will be likely to apply.
4. Speculation: The Phase 3 may only need a 90-day "Assessment Period" making it easier for patients to commit to the trial; and more likely to apply.
5. Speculation: Phase 3 may not be as "selective" as the Phase 2A; making it easier for a wider range patients to be accepted.
6. Speculation: FDA Breakthrough Therapy Designation.
It depends how deep the formula can get.Is the consensus that FX-322 regrows both the OHCs and the IHCs or just OHCs?
Based on other international Phase 3s, it'll be announced all at once.Do you think it's possible we will know something about a potential Phase 2 or Phase 3 study outside of US from Astellas during 2021?
The majority of experimental drugs do not get FDA approval. Let's HOPE there is a Phase 4!I'm sure there will be a Phase 4, but it's a post approval monitoring study so it won't affect the wait.
Though obviously I can't guarantee it, it seems very likely to me FX-322 will get approved (so far safe, effective, unmet need). I don't think it's possible to fake what they have already accomplished.The majority of experimental drugs do not get FDA approval. Let's HOPE there is a Phase 4!
Hm, ok. I'm sure I read something about a payout-milestone from Astellas to Frequency Therapeutics when they dose the first person in a Phase 2 (a or b) in Europe.Based on other international Phase 3s, it'll be announced all at once.
Why do you think this?I don't think it's going to work. I was optimistic but I think it will help hearing but not like we think it will.
It's probably just going to improve speech in noise and word recognition. I don't think that will help tinnitus.Why do you think this?
I too believe approval is likely, but many drugs demonstrate safety, efficacy, and unmet needs in Phase I and II only to flame out in Phase III.Though obviously I can't guarantee it, it seems very likely to me FX-322 will get approved (so far safe, effective, unmet need). I don't think it's possible to fake what they have already accomplished.
So, in that case, there will be a post market Phase 4 monitoring study as is standard for FDA approved drugs.
Most of us probably won't wait for completion of Phase 4 to try FX-322, though, since it would be available after approval before then.
I was under the impression the company had reports that it helped with tinnitus and was studying it.It's probably just going to improve speech in noise and word recognition. I don't think that will help tinnitus.
When my ears worked I didn't have tinnitus. Now that they don't - I do.It's probably just going to improve speech in noise and word recognition. I don't think that will help tinnitus.
But Carl LeBel said that they have already had anecdotal reports of tinnitus improvement from participants (when they have gone to see the ENT). What do you think is needed to address tinnitus then?It's probably just going to improve speech in noise and word recognition. I don't think that will help tinnitus.
Why not? The theories for tinnitus line up with hearing loss, it makes sense that you'd lose part of your hearing by going to loud events and lose the high frequency cells.It's probably just going to improve speech in noise and word recognition. I don't think that will help tinnitus.
Someone can correct me if I'm wrong, but I don't believe FX-322 had any effect on speech in noise in the Phase I/II trial, it only improved the Word Recognition Score. The theory right now is that damage to synaptic connections is what causes speech-in-noise hearing loss. Though we'll have a better idea if that's true within the next month (when the OTO-413 results come in).It's probably just going to improve speech in noise and word recognition. I don't think that will help tinnitus.
This is why it's thought that there will be a Phase 2b/Phase 3 combined trial as members like @FGG and @Diesel have pointed out. That way it is going to enable Frequency Therapeutics to get paid for their two trials obligations and also enable them to complete the final phase trial too.Hm, ok. I'm sure I read something about a payout-milestone from Astellas to Frequency Therapeutics when they dose the first person in a Phase 2 (a or b) in Europe.
FX-322 showed improvement in word-in-noise, of 20% over baseline. But, with a p-value of .211, it's not statistically significant. So, either the sample size was too small or the ceiling effect was a factor.Someone can correct me if I'm wrong, but I don't believe FX-322 had any effect on speech in noise in the Phase I/II trial, it only improved the Word Recognition Score. The theory right now is that damage to synaptic connections is what causes speech-in-noise hearing loss. Though we'll have a better idea if that's true within the next month (when the OTO-413 results come in).
There were already reports of improved tinnitus from the Phase I/II trial. My gut assumption is that in the next 1-5 years we're going to learn that there is no single cause or solution to tinnitus. Fixing hair cells will cure some, fixing synaptic connections others, etc etc.