Member- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Why March: Stock Price. New eyeballs on the drug. Breakthrough Designation application.
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Write your House or Senate representative about the Promising Pathway Act. This enables the FDA to allow "provisional approval" of a drug as long as it shows considerable efficacy over current alternatives and has a favorable safety profile.
https://www.congress.gov/bill/116th-congress/senate-bill/3872
This might be the best legislation to enable FX-322 to be commercially available prior to the end of the pivotal phase.
I think that while this is a downer, it is a necessary evil to ensure medicines are safe and actually fit for purpose. I think most people would at least like to know what the safety outcomes and/or side effect outcomes of a medicine actually are before taking it. Furthermore, while we well know that FX-322 is not useless and does achieve its intended and stated purpose(s), the FDA trial process at least enables a medicine to be identified as actually doing something.
Though that being said, I would rather that the treatments were made easily accessible to people should they choose to want to try these providing that they are proven to be relatively safe, don't have any known side effects declared at the time and that the treatment has demonstrated its stated benefit as well.
While we all know that getting an early access to a medicine is ultimately up to the pharmaceutical company developing it, I do feel that the medicine should be available much more simply through compassionate access/right to try than the process currently allows it to be.
Well especially when you consider that FX-322 is also a lot safer than all those to be decriminalised drugs it really should be not even up for discussion or debate and people should be simply allowed to try medicines under the same principals.
I agree that safety has been proven to date with FX-322, however there is always the possibility that this might change and we may end up discovering some adverse outcomes and/or side effects with it at a later date. Thus while I do believe that the medicine really requires further assessment of its risks and its safety situation before it is released, I am of the view that this doesn't necessarily need to be taken to the same levels that tend to be required by the FDA at present either. Essentially it is I think redundant to use the same criteria around safety for all medicines especially, firstly, when it is obvious - before any trials begin - that certain treatments are going to pose greater risks and safety concerns and, secondly, there is often a good idea on the safety risks with medicines during the earlier trials.
Thus I feel that patients, Frequency Therapeutics and the FDA can all be actually much more confident that treatments like FX-322 won't pose as significant risk to patients as just say something like Ritalin which is basically speed which is manufactured commercially without the harmful side effects and additions in the illicit version. Therefore while I am well aware that the FDA requires standards to be set when it comes to safety, I definitely do not think that it is necessary to be so stringent on a seemingly safe medicine like FX-322.
The expanded access on the other hand happens to come down to the company that is manufacturing the medicine and this is a necessary but dissatisfying byproduct of this process. Though the wait may be unfortunate and horrible for some, it is also reasonable that the organisation developing it has the final say on whether they will allow early access or not. They are ultimately the ones who are responsible for its release and for funding the trials and the manufacturing and the distribution until the medicine actually gets publicly released. Thus while it might be for the good of patients to have medicine available early from expanded access, it might be unaffordable or unreasonable for Frequency Therapeutics to actually release FX-322 under expanded access either as well.
While it is excruciating and bothersome to have to wait to see whether we will get a treatment such as FX-322 that ultimately will regrow hair cells, my concerns are somewhat alleviated by the fact that the treatment has shown it works well when used in cochlears in lab work. What I would also say is that if FX-322 is shown to work well when it is injected into individual's ears essentially during the current trial then this will make me even less worried and/or anxious with having to wait to obtain the treatment, even if it is going to mean it won't be made available until the full trial process is completed. Consequently we will know that there is something and that it is just a matter of time rather than having nothing.
Nothing tells me that Frequency Therapeutics will be going slowly to get FX-322 to market at all if it is successful and therefore I see that this treatment will be released at its earliest convenience. Clearly it is an aim of Frequency Therapeutics to turn out a successful FX-322 treatment and also deliver it in the shortest time possible as well. We have seen Frequency Therapeutics tell us this is their goal time and time again actually throughout the trial process which tells me that they genuinely want to help us.
This is interesting legislation and it is clear that there's this tendency from both parties to try to enact legislation that tries to make medicines more accessible sooner. It is plausible that this legislation may get passed sooner too since this pharmaceutical area actually appears to be bipartisan, hence how both parties have been pushing for things to happen like reducing the costs of medicines and also actually implementing processes to enable treatments to then get released a lot sooner.
Some similar positive outcomes have also been seen with the decision to try to reduce the cost of prescription medicines. This tends to be very positive going forward and also both reforms are very positive for patients and pharmaceutical companies. The pharmaceutical companies can commence selling the medicine actually sooner than what they would have anticipated and also will have certainty around things such as the need to commence production, which they might have held off of had they not had some reasonable certainty that their treatment was going to get passed. This benefits the patient too as it will mean that they then can get access to treatments a lot sooner than they would have previously been able to.
I contacted my Senators and Rep. Hoping this gets passed as the identical House Bill, HR 7269 has bipartisan support. Really though, this should be beyond politics and enacted ASAP.
Michael01
Member
I don't suppose there'd be a similar agency I could contact regarding FX-322's compassionate release here in Australia? Or when it's released in the U.S, does that mean it'd be available here as well due to the treaty between the U.S and Australia regarding that we use the FDA's drug approvals on such things? Just that I've been told that a fair few doctors don't want to be bothered with such things as compassionate release due to the paperwork involved so if I had a agency that could assist me with such things...
Keep in mind what FX-322, on record, is designated to treat, if proven effective in the current phase - Mild to Moderate Sensorineural Hearing Loss. Realistically, provisional approval of this potential miracle drug is unlikely to occur due to other resources available i.e. hearing aids.
Additionally, the release of limited data after day 90 is perhaps designed to enhance investor interest going into Phase III. It's all about the revenue at this point and greater investment in FX-322 will be the catalyst to render its usefulness within the next 2-3 years.
Doesn't FX-322 treat moderate to moderately severe hearing loss its current trial? The thing is though that hearing aids are actually nothing like what FX-322 offers so I don't know how you can even compare the two and use them as a comparison as to why provisional approval may or may not be granted. In fact I would contend that the availability of hearing aids would have little to no bearing on whether FX-322 may or may not be granted expanded access for multiple reasons.
Australia follows the criteria set by the FDA mutually so if the FDA has approved a medicine in the US and released it, then it will also be approved for release in Australia (and also vice versa).
- Apr 6, 2020
- 1,031
- Tinnitus Since
- 2016
- Cause of Tinnitus
- 2016: headphones, 2020: worsened thanks to Rammstein
I truly don't know of Australian agencies that help you with that. But I do know that My Tomorrows, even though located in the Netherlands, operate on a global scale. You could ask them about the procedure of receiving compassionate use concerning Astellas in Asia & Australia.
Here's the link:
https://mytomorrows.com/en/get-in-contact
I agree to some extent. I think after injecting people with this for three years now though, even with it being a rather small amount of people, if there were seriously adverse general side effects, we would have known by now.
However, I do believe that side effects indeed needs to be explored more, and where you could potentially see complications is in conjunction with other medical conditions or in combination with other medicines. For example, maybe people with asthma, people taking blood pressure medicine, people with migraines could see side effects that others don't. (Only as an example of course).
It's questionable whether 'provisional approval' would be granted based on considerable efficacy over current alternatives, which, in my opinion, it would not unfortunately.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Hearing aids are classified as a device to treat hearing loss. The device offers no disease modifying effect.
Promising Pathways is intended specifically for drugs or biological products that offer a disease modifying effect; in particular where no alternatives exist, and/or where the drug in application provides considerable efficacy in modifying disease progression while maintaining a favorable safety profile.
Last time I checked, there aren't any drugs that would be alternatives to FX-322 to modify the progression of hearing loss. Hearing aids aren't a drug so don't qualify as an alternative under the language of the bill.
The problem here is logistical, the US needs 3 functioning branches looking to move legislation like this though to law. Last time I saw the news, 1.5 branches are not doing the job of governing at the moment, or delaying the process that could be made in this regard; so this bill may not even be effective by the end of 2021. Which may not even be relevant for FX-322.
The Promising Pathways Act is for drugs intended to treat, prevent, or diagnose serious or life-threatening diseases or conditions for patients who are battling critical conditions. These individuals would gladly trade their condition for sensorineural hearing loss if given a choice.
I am a true believer in FX-322 and have invested in Frequency Therapeutics, yet my point is that mild, moderate, or severe hearing loss would be an unlikely candidate for provisional approval under this Act. The availability of hearing aids for this degree of hearing loss would further invalidate any consideration for approval prior to market. The clinical trials will run its course through Phase III, be proven very effective, and only then will it become accessible... in my opinion.
I guess it will be hard to get compassionate use for hearing loss but I believe those of us who suffer from hyperacusis and tinnitus that reacts to noise at lower thresholds has a better chance at getting compassionate use from Frequency Therapeutics as these are debilitating conditions especially if someone is homebound.
https://www.businesswire.com/news/h...-Reports-Third-Quarter-2020-Financial-Results
What's the difference between "Analysis of Day-90 Data" & "End of Study Readout" which are to be completed Q1 and Q2 respectively in 2021?
What's the difference between "Analysis of Day-90 Data" & "End of Study Readout" which are to be completed Q1 and Q2 respectively in 2021?
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Day-90 is a snapshot of all patient outcomes only at their 90-day follow-up visit.
End of study reveals all data about participants.
WickedCarnival
Member
- Aug 16, 2018
- 68
- Tinnitus Since
- Late Autumn 2016
- Cause of Tinnitus
- Unsure between azithromycin or viral infection
Many of the psychedelic drugs being decriminalized such as psilocybin, ayahuasca, and MDMA have been showing potential to relieve tinnitus by rapidly re-wiring parts of the brain that respond to anxiety and threat detection that causes the tinnitus feedback loop. Not only that, but effective for helping treatment-resistant depression and anxiety. I bet many people here qualify for the diagnosis of treatment-resistant depression/anxiety regardless of whether they have tinnitus. But that's just my hunch.
I predict a "tinnitus destroying" treatment combo would be be FX-322/Hough Ear Institute Pill + psychedelic psychotherapy / CBT that will address both the biological damage, and psychological pathways. That would be a highly effective strategy as psychedelic therapy is usually no more than 4-6 sessions, and doesn't require regular dosages of the drug (unless a patient is experimenting with microdosing).
This would be as close to a "cure" as you can get. The upfront cost and investment would be high to a patient, but in the long run would save so much money by eliminating hearing aids, noise/TRT devices, snake oil scams, chronic use of medications such as SSRIs (which many side effects include tinnitus, diminished creativity, sexual dysfunction), and useless ENT appointments. And to boot, proper psychedelic treatment can enhance patients' capacities for creativity and improve sexual relationships. All good things!
So at the end of Q1 2021 we will see a simple before and after of their results, and at the end of Q2 2021 we will see a report after each injection and (hopefully) the steady improved hearing results coinciding with each injection?
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
If Phase 1/2 patients already reported improvements in their tinnitus from a single dose of FX-322 alone, why would adding psychedelics provide any additional benefit?
Seems to me that the regenerated hair cells were enough to begin reversing the brain's perception of tinnitus without all the "add-ons."
Speaking anecdotally: If I woke up one morning shortly after receiving FX-322, and noticed my tinnitus continued to be quieter than usual, I would certainly feel pretty good about it and would naturally expect to begin reversing the depression/anxieties associated with the conditions.
I'm not sure others here agree?
As soon as psilocybin therapy becomes legal in Sweden, or on trial for that matter, I'm going to jump on it.
- Sep 21, 2016
- 1,051
- Tinnitus Since
- 2011 - T, 2016- H, relapsed 2019
- Cause of Tinnitus
- noise-induced
Yes, Johns Hopkins in the United States and the prestigious Imperial College London both have centres dedicated to exploring the use of psychedelics in mental health treatment (LSD, psilocybin, mushrooms, ayahuasca, DMT). The MAPS organisation in the US has also done a lot of work on MDMA therapy, which is currently in Phase 3 trials if I recall correctly with impressively high success rates for PTSD treatment.
I think this seems plausible. Treatments like Hough Ear Institute Pill/PIPE-505 will deal with a lot of the underlying issues. I'd rather avoid taking drugs like psychedelics unless it is inevitably required in order to completely treat tinnitus if the regrowth medicine doesn't deal with the underlying causes. Consequently I have real hope that the treatments for regrowth really do work and provide positive benefit to us, for not only tinnitus but also for other ear issues.
Frequency Therapeutics has started recruiting for their Phase 1b Severe SNHL clinical trial:
FX-322 in Adults With Severe Sensorineural Hearing Loss
FX-322 in Adults With Severe Sensorineural Hearing Loss
We will also see the results unblinded which means that we will see what people got and whether they benefitted from FX-322 or not.
Street Novelist
Member
- Apr 2, 2018
- 293
- Tinnitus Since
- February 2018
- Cause of Tinnitus
- Listening to loud music through headphones
It looks like we will have to wait several years before FX-322 is available. I guess Billy and Diesel are right. Barring huge news in 2021, it probably won't be released early. Let the depression continue.
- Sep 21, 2016
- 1,051
- Tinnitus Since
- 2011 - T, 2016- H, relapsed 2019
- Cause of Tinnitus
- noise-induced
I think psychedelics are looking really promising for potentially treating certain mental health conditions but I'm not sure if they would help with tinnitus. From my own experience with them there was no effect on my tinnitus whatsoever. I think the regenerative drugs would help our systems revert back to normal and undo the maladaptive plasticity that has occurred. But it's still something interesting to ponder.
Log in or register to get the full forum benefits!
Similar threads
