Pipeline Therapeutics

Discussion in 'Research News' started by FGG, Nov 14, 2019.

    1. FGG

      FGG Member Podcast Patron Benefactor

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      Found this announcement today:

      https://www.businesswire.com/news/h...Participate-Stifel-2019-Healthcare-Conference

      Here is their official website:

      https://www.pipelinetherapeutics.com/

      It appears to be a relatively new biotech company. Of note, Stefan Heller is on their advisory board.

      The news article lists their candidate PIPE-505 as another gamma secretase inhibitor but for cochlear synaptopathy rather than hair cell growth.

      From their website, they may actually have two separate compounds for synaptopathy about to start phase 1, however.
       
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    2. JohnAdams
      Festive

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      Wow. Very interesting. Looks very promising. Nice find.

      upload_2019-11-14_9-35-52.png
       
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    3. HootOwl

      HootOwl Member Benefactor

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      “A Phase 1b/2a study of PIPE-505 in SNHL is expected to begin enrolling patients in 4Q 2019, with topline results expected in late 2020”.

      Here’s hoping that one of their exclusion criteria isn’t tinnitus.
       
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    4. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

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      So a combined phase 1 and 2 study? Interesting.

      Also, what indication would they even have that you had cochlear synaptopathy? Speech in noise? Wouldn't tinnitus be a prime indicator?
       
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    5. AUTHOR
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      FGG

      FGG Member Podcast Patron Benefactor

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      Speech in noise is a primary indicator, yes.

      Hopefully there will be an online transcript of the CEO's 11/20/19 conference talk and it will include study inclusion criteria.
       
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    6. HootOwl

      HootOwl Member Benefactor

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      From what I understand yes, difficulty hearing speech in background noise is the predominant indicator of synaptopathy. However, some companies seem very concerned about eliminating variables in their trials (as we’ve seen with Frequency Therapeutics) and tinnitus often seems up on the chopping block.

      OTO-413, currently the only trial available for cochlear synaptopathy, made it very clear to me that “bothersome tinnitus” would exclude me. It’s very frustrating, and I’m hoping Pipeline Therapeutics will not follow suit.
       
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    7. Jurger

      Jurger Member

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      Great find and another sign things are moving in the right direction for hearing loss. Interesting they’re focused on mild to moderate hearing loss due to synaptopathy. I had no idea you could get up to moderate hearing loss from that.
       
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    8. AUTHOR
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      FGG

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    9. HootOwl

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    10. JohnAdams
      Festive

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    11. Jurger

      Jurger Member

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      Two questions that come to mind:

      1. What is their other eardrug, PIPE-336, intended for?

      2. Is Phase 1b/2a snake oil tongue for Phase 1/2?

      Hope this doesn’t become Pipedream Therapeutics.
       
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    12. HootOwl

      HootOwl Member Benefactor

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      Whats interesting that if you open their presentation from the 49th Chicago Neuroscience conference you’ll see that PIPE-505 not only cured synaptopathy but ALSO regenerated hair cells.

      Curiously enough PIPE-336 was missing from this presentation. They will be attending another conference next week so maybe we will get more information then.
       

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    13. JohnAdams
      Festive

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      Robert Jackler at Standford said that regenerating hair cells restored synapses. It seems like all of these things are related.
       
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    14. Jackjohnson183

      Jackjohnson183 Member Benefactor

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      So FX-322 and Regain/Audion should do the same thing as well?
       
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    15. Jurger

      Jurger Member

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      We don’t know if those drugs can regrow synapses of hair cells that remain in the inner ear. The new hair cells those drugs regrow probably do have synapses. If I’m not mistaking Pipeline’s drug primarily intends to regrow synapses that were damaged without loss of the hair cell.
       
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    16. Jackjohnson183

      Jackjohnson183 Member Benefactor

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      Do you believe that if these drugs did work would we basically have our ears before we had tinnitus and hyperacusis or do you think we would be more easily susceptible to damage even if it did get rid of our tinnitus and hyperacusis?
       
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    17. Jurger

      Jurger Member

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      I think they already found out there’re genetic components to hearing loss. By that I mean not genetic deafness or anything, but genes that make you more susceptible to hearing loss during life. These drugs are not going to solve that.
       
    18. mrbrightside614

      mrbrightside614 Member

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      If that’s what people are worried about once this curse has been lifted, take Pramipexole and get on with what’s been left of your life.
       
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    19. AUTHOR
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      FGG

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      Looks like they have updated their website. No longer mentions PIPE-336.
       

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    20. HootOwl

      HootOwl Member Benefactor

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      I have some more information. Of interest is that this compound is not just comparable to NT-3, but is supposed to be more potent. The finish line is getting closer and closer.

      @JohnAdams youve wanted your NT3 human trials, well you’ve got em now :33

      ———

      I received your emails and can try to answer your questions here.

      • Regarding NT3, yes, we followed the protocol used by Charles Liberman and find that PIPE-505 is more effective at restoring synapses in models of cochlear synaptapthy. We are very excited about these results and have filed an IND with the FDA to test this compound in patients with NIHL associated with cochlear synaptopathy.
      • Yes, PIPE-505 is able to penetrate throughout the cochlea from the apex to the base. We have conducted extensive inner ear pharmacokinetic experiments to demonstrate this exposure.
      • To your question around tinnitus. I am familiar with the suggestion that some forms of tinnitus may be caused by cochlear synaptopathy. We have no direct evidence for or against this claim. We will not be testing our compound in tinnitus patients under our current IND but this is something we could explore in the future.
      Upon asking about tinnitus as an exclusion factor:

      Tinnitus may be an exclusion factor. I would need to check in with our CMO. More importantly, we will be trying to enroll patients with mild to moderate bilateral hearing loss (no more that 40dB hearing threshold) who also have evidence of cochlear synaptopathy by word in noise test or speech in noise test.

      Also it is definitely confirmed that it will be a phase 1/2 combined trial. And that they have seen benefits for ototoxic induced synaptopathy as well, not just noise induced.

      No recording of their presentation unfortunately :/

      And while I know they say they have no direct evidence in synaptopathy being the underlying cause of tinnitus, I think the fact that tinnitus is included in their Delivery Patent isn’t JUST pre emptive. I don’t think they would include it in there as a passing fancy.
       
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    21. JohnAdams
      Festive

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      My main gripe about that stuff is that it would need to pass extensive safety trials and then efficacy trials, and I know the world doesn't know that it is safe, but I do, so to have to sit and wait for the government to verify something I already know is just maddening.
       
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    22. HootOwl

      HootOwl Member Benefactor

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      Totally get it, but I know we all thought Decibel would have started this years ago so it feels like the gears are finally starting to turn. They should have turned 10 years ago, and it drives me crazy that all we can do is sit on our hands until these trials are complete, but the fact that they are combining safety and efficacy is heartening. It condenses this maddeningly long time line even just a little bit.
       
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    23. Mathieulh
      No Mood

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      Until this treatment gets available to the public, and we can assess its efficacy, this is more in the line of "pipe dream therapeutics". (Pun intended)
       
    24. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

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      Sadly, even if this does restore synapses perfectly, tinnitus may need a multi faceted approach. New hair cells, new synapses, and sound therapy.
       
    25. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

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      Sound therapy? You mean bimodal neuromodulation right?
       
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    26. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

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      No, just sound therapy. I'm not saying nueromodulation wouldn't be good too. I have zero experience with that so I cannot say.
       
    27. Caveman

      Caveman Member

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      Well, this would explain why some participants at FX-322 phase 1/2 trial had their speech-in-noise parameters improved after the injection!
       
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    28. Chriscom

      Chriscom Member Podcast Patron Benefactor

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      That's amazing if I properly understand past comments related to other drugs whose penetration throughout the cochlea is a stumbling block. Have they devised a new delivery method or is there something about this drug that simply diffuses more thoroughly.

      Great development regardless.
       
    29. AUTHOR
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      FGG

      FGG Member Podcast Patron Benefactor

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      Per their patent, it looks like they are using a aqueous formula with poloxamer 407. This is what Otonomy uses for their sustained release intratympanic Dexamethasone (per PubMed). Obviously if it's for Meneire's patients (Otonomy's Dexamethasone formulation I mean) it would have to diffuse to Apex or wouldn't be very useful for Meniere's. It follows that Pipeline's drug should have good penetrance there, too.
       
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