Woo! Been a while since I last posted here! Looks like we've got a few new regulars, and we're back on the old anxiety carousel!
I'll drop this here, and then I'll see you all in a week:
https://investors.frequencytx.com/static-files/47014168-736e-4a25-9435-b1a8bf19599e
My thoughts from the recent PR sweep:
1. The drug works, it just doesn't go deep enough. The long-term "durability" study reinforces that notion.
2. Word scores improved after 90 days from the Phase 1/2, then declined slightly for some, while others fell back to baseline. It's highly likely that the part of the patient's cochleas that didn't see improvement from FX-322 still continued to age; explaining the reduction in word score. In other words, the word score likely fell because everything under 8 kHz continued to wear. Which brings me to my next point:
3. The fact that most patients retained their hearing at 8 kHz up to 2 years later from the original dosing is ACTUALLY HUGE. That could be interpreted as those new cells above 8 kHz are hanging on, like new, just as intended from the PCA approach.
4. I would believe researchers over audiologists. Audiologists see an inevitable paradigm shift in their industry; so will say anything to discredit a direct challenge. Researchers responding to FX-322's progress are looking at the data; they seem to continue to give a balanced review (it's compelling data, but we need more). Do a little research about LASIK when it first started to pick up steam in the 90s (in the US)... there was some negative PR from glasses manufacturers and eye care coalitions.
5. Frequency Therapeutics seems to be getting a little more loose about revealing the "anecdotes about patients tinnitus improving." This shows confidence. I would not be surprised if in the long-term durability study, patients were interviewed re: how their tinnitus was doing.
6. Frequency Therapeutics is planning on testing FX-322 for Severe Hearing Loss and Age-Related Hearing Loss. Look for updates on those two studies between now and the Phase 2A results being released. They could easily do them with their on-going university relationship in Texas. I would GUESS that the measured outcomes will look a lot like the Phase 2A. Could be a winter 2021 surprise!
1. I absolutely agree about FX-322 working effectively but currently not going deep enough in the ear. I think that there is a lot more confidence with the stability and durability of the treatment results and benefits now that we have seen these outcomes. I think this is why the drug delivery methodology is going to be the major focus from Frequency Therapeutics in the near future. Finding ways to improve the drug delivery is seemingly the missing link and this will improve not only the benefit provided by FX-322 but also increase the number of people who can be assisted by taking FX-322.
At this point in time, I can clearly see that either the companies making these ear medicines like Frequency Therapeutics or drug delivery companies will initiate work to improve the dosing. It is obviously in the interests of the medicine development companies like Frequency Therapeutics to improve the effectiveness of delivery as this will mean it is possible to treat a wider group. However if a drug delivery company or companies can come out with improved techniques then they can provide this to all companies who are manufacturing ear medicines. This is a highly positive situation, as drug delivery companies now have a potentially highly profitable market to work with. Thus there will be huge interest in this project from the drug delivery sector and drug delivery companies and I am sure that we will see significant work take place. Pretty sure we have already seen the foundations laid for this type of work with the investigations and research into dosing via cochlear pumping techniques and that there will be more of this type of research continuing.
2. Your position that word scores fell due to a worsening at some lower frequencies is probably a fair summation. However I would also wonder whether there was some other factor at play. I would probably wait to see some further results to confirm that worsening at the lower frequencies was the cause. This is because while this is a likely cause, there are still some unknowns around the actual benefits of FX-322 and also there has only been limited testing done to date.
3. The fact that the benefits of the FX-322 have been maintained 20 months after administering it tells me that this further demonstrates that the FX-322's performance appears to be legitimate and that the benefit is real. Furthermore it shows that this progenitor cell activation process is an effective and legitimate technique. I agree with you that this is huge and also a major breakthrough. This shows me that the process does work and makes me feel very confident.
4. The LASIK comparison is highly relevant when it comes to looking at FX-322 and the views that some bodies and some individuals have towards it. While some entities have been balanced in their commentary about FX-322 and its performance and capabilities, there have been other entities who have been reasonably keen to be negative/critical of FX-322 too.
Based off of the information I have found out about when LASIK started in Australia, it seems that some in the eye care industry were very focused and keen on using whatever information they could to paint LASIK in a negative light. This didn't just include plausible and valid negative information (such as the cost of the treatment) but also groups were widely interested in using positive outcomes from early treatment using LASIK to try and show why it was not necessarily a good choice of treatment. We have also seen these tactics used by those who are against and are critical of FX-322.
I think that this is going to be a likely tactic used by groups like hearing aid manufacturers. The issue in Australia was that glasses used to be expensive and cost $400 a pair in mid 90s and actually now cost $99 for a reasonably good pair at the big brand/chain glasses stores. Optometrists were never going to admit this, though it is blatantly obvious that their criticism and concerns about LASIK were financially driven.
I can see this also playing out with hearing aid manufacturers, as they will have their business potentially reduced if treatment like FX-322 means that fewer people are using the hearing aids and/or people are only needing to utilise the basic devices.
In the end however, LASIK won out and became a highly viable option/alternative to glasses once it could be demonstrated the effectiveness and safety of the LASIK procedure was to a high standard.
I believe that the companies undertaking FX-322 and related treatments will simply have to go hard on the messaging and the information campaigning. My memories of watching TV as a child were that there were LASIK ads bombarding the TV to inform people of this option. The end result was that they helped to build up the knowledge of the procedure and thus candidates were willing to have the procedure. This meant others could now have first hand accounts of the procedure (such as what I was like and how it went) from others. This in turn then meant more people took up LASIK because if they previously had concerns these were being alleviated by the evidence from the procedure outcomes.
Thus I can see all regenerative treatments needing to follow the same path because not only are they going to need to educate people on the potential benefits of this treatment but this is also the most effective way to negate the resistance from the status quo.
5. I know that Frequency Therapeutics need to remain rather guarded and cautious when it comes to what information they release so they don't infringe the FDA/stock market rules, however I actually think that the fact that they have released some small unofficial hints about the benefits of the treatment and what is going on is promising progress and also going to make people feel more confident. I am pretty positive that the cryptic clues that Frequency Therapeutics has released about FX-322 give us a good insight in to what FX-322 can potentially do and also what Frequency Therapeutics will be doing in the future.
6. Although we don't know what is happening internally, I must say that that the decision to expand the scope of the operations to look at some other treatment groups for example definitely suggests some positive progress is being made and also that Frequency Therapeutics is robust. Right now I think that this is a good sign of progress.