The CURE for Hearing Loss (Part 3) – BAD NEWS | FX-322

in this video i'm talking about the most recent clinical trial news about frequency therapeutics and why their fx 322 drug may not be the cure for hearing loss after all coming up hi guys cliff olson doctor of audiology and founder of applied hearing solutions in phoenix arizona and on this channel i cover a bunch of hearing related information to help make you a better informed consumer so if you're into that make sure you hit that subscribe button and don't forget to click the bell to receive a notification every time i post a new video the biotech company frequency therapeutics recently completed two clinical trials with their fx 322 drug in early 2021 now if this is the first time that you've even heard of fx322 as a possible cure for hearing loss let me bring you up to speed with what this drug is actually intended to do the vast majority of hearing losses are sensorineural in nature which means that there's typically damage to the inner and outer hair cells inside of your cochlea which is your hearing organ when these hair cells are damaged or no longer present the ear has a very difficult time of receiving sound information and then sending that information up to the brain which results in a hearing loss outer hair cells primarily determine how loud sound needs to be before you can hear it your outer hair cell function is largely indicated by the x's and the o's on an audiogram generally speaking the lower these markings are on the graph the less outer hair cell function that you actually have inner hair cells on the other hand primarily determine how clear sound is by the time it reaches your brain your inner hair cell function is largely indicated by your word recognition score percentages in general the lower these percentages are the less inner hair cell function you have according to frequency therapeutics fx 322 is designed to treat the underlying cause of sensorineural hearing loss by regenerating hair cells through activation of progenitor cells already present in the cochlea if successful fx 322 could be a cure for hearing loss by regenerating lost hair cells now i do have two other detailed videos that i will link in the description where i talk about the progress of fx 322 up to this point but let me go ahead and fill you in real quick frequency therapeutics has been progressing nicely through several fda clinical trials for their fx 322 drug in the earlier safety studies it was determined that fx 322 was safe and had no adverse side effects after being injected through the tympanic membrane into the middle ear space however the exciting thing that they started to identify in these studies was an improvement in word recognition ability and quiet and in noise as well as some individuals having an improvement in high frequency pure tone thresholds of course this news was really exciting especially considering it only took one dose of fx 322 to elicit an improvement in hearing ability in the test subjects now if you're a nerd like me you can actually read through the entire original study from the journal of otology and neurootology that i have linked in the description as well naturally this good news led to additional excitement for the phase 2a clinical trials which were intended to identify if multiple doses of fx322 had an even bigger regenerative effect over placebo however the results of the multiple dose fx 322 clinical trial showed that all of the groups that received the fx 322 drug showed no actual hearing improvement over the placebo group so how did fx 322 show improvement with single dose trials but not multiple dose trials well the answer is nobody really knows but there is some speculation that because you have to have repeated injections through the tympanic membrane into the middle ear space that these multiple injections may have created an unfavorable environment for hair cell regeneration obviously this news is upsetting because a lot of individuals who've been following fx 322 like i have over the past several years was really expecting to see a significant improvement in hearing ability after having multiple doses of fx 322 even the company's stock price took a huge hit with this bad news indicating that investors saw this as a huge setback to fx 322 i on the other hand don't necessarily see it that way because what you might not be aware of is that frequency therapeutics is also running a phase 1b clinical trial for a single dose of fx322 to determine tolerability over a 90 day period and in this study 34 percent of test subjects saw at least a 10 improvement in word recognition ability which indicates that there still could possibly be improvement in inner hair cell function is this earth-shattering news no it's not but it does show that fx 322 still has some promise when it comes to the regeneration of hair cells inside of the cochlea and if it is in fact inner hair cells that fx 322 has the potential to regenerate then this is really good news for individuals who wear hearing aids because inner hair cell function controls the amount of clarity that you get from hearing treatment so hearing aids actually become more effective so what does this mean for frequency therapeutics and the future of fx 322 well it means that they're going to start focusing on single dose applications of their drug to hopefully restore hair cell function with just one dose and they're going to start rolling this out to other populations as well so individuals who have age-related hearing loss and who have a severe hearing loss which both by the way are currently under clinical trials they will also continue to see if fx 322 not only has an improvement in hearing ability but tinnitus as well at the end of the day is this good news when it comes to trying to find a cure for hearing loss of course the answer to that is no but even studies that don't necessarily give you the results that you want are an opportunity to learn and get better and why some individuals may think that this is a huge setback for fx 322 and frequency therapeutics i don't see it that way i see this as a learning experience for the company so they can learn and get better so don't give up hope yet if you have hearing loss continue to treat your hearing loss because there are people out there who are way smarter than you or i who are on top of this and even if fx 322 doesn't prove to be the magical cure that we've all been waiting for something eventually will be that's it for this video if you have any questions leave them in the comment section below if you liked the video please share it if you want to see other videos just like this one go ahead and hit that subscribe button also feel free to check out my website drcliffaud.com [Music] you

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