Pipeline Therapeutics

Looks like we're getting the news from everything, Pipeline Therapeutics, Otonomy, and Frequency Therapeutics in mid 2022.

 

2022 is a huge year lol.

Crossing fingers not just for me but for those truly suffering.

 

I know this has been talked about before, but with their supposedly unique delivery system that can reach all the way to the end of the cochlea, I think this drug should fully repair hearing due to sudden noise exposure.

A direct quote from their July 2020 press release: "The dual mechanism of action for PIPE-505, involving repair of the cochlear synapse and the regeneration of outer hair cells critical for hearing quality and sensitivity, uniquely positions this small molecule to address two of the main cochlear elements commonly lost in SNHL."

 

Yeah but from what i've heard the regeneration of outer hair cells is not sufficient enough to completely erase hearing loss. It regenerates only a few hair cells, the main purpose of this drug remains to regrow synapses.

 

This is true!

 

Where can I read more about that it's not enough to regrow hair cells?

In the presentation here they seem pretty certain that regrowing the hair cell that is lost will make the nerves connect back to it:

Hearing Health Hour Webinar | The Present and Future of Inner Ear Hair Cell Regeneration

Hearing Health Hour Webinar | The Present and...

And so what I can say is there is a lot of evidence that in the mouse when you can create hair cells in a place where they're not supposed to be the spiral ganglion neurons will follow, and they're pretty good at sorting out and trying to find a target to innervate. And I think there is a very good chance that if you made a hair cell in the right place that it could get innervated and the neuron is already connected to the central nervous system and will be there and ready to go. So, of course it's going to depend on why the hair cells are lost and what the state of the spiral ganglion neurons is, but I think in many cases, yes – I think they could be connected in a functional way.

When it comes to tinnitus things seems more complex according to these researchers:

Once you have the tinnitus it's not maintained anymore by the cochlea, it's maintained probably by the cerebellum and the brainstem and that's a different ballpark.

So despite its complexities it seems easier and more concrete to fix hearing loss than tinnitus.

I'd like to fix both of course, but definitely tinnitus firsthand.

I so wonder what I will hear in my head on my death bed – hopefully silence and crystal clear hearing since at least a decade back or two.

 

You can look into theories about hidden hearing loss where some articulate that the hair cell is intact however the synapses have been undone. This is what Pipeline Therapeutics is attempting to amend. There are individuals who have no distortions or issues with audiograms yet struggle with high frequency sounds or have troubling understanding words in noise.

 

Any news about the Phase 1/2 results?

I checked ClinicalTrials.gov and they don't talk about results. In the meanwhile, it's listed as "completed" since few months now.

 

Everything is in this thread, read the posts

 

Pipeline Therapeutics Appoints Eef Schimmelpennink to its Board of Directors

 

Pipeline Therapeutics to Present at Upcoming March Investor Conferences

They're having a presentation very soon.

• 32nd Annual Oppenheimer Healthcare Conference
  • Tuesday, March 15th, 2022 at 1:20 pm ET

Hopefully, there is some info about PIPE-505 there. I have my suspicions that the results from the Phase 1/2a trial were not too great considering all the delays.

 

Pipeline Therapeutics have changed their "About"-paragraph in their articles from the News-section from:

Pipeline’s lead clinical program, PIPE-505, is in an on-going Phase 1/2a study to treat sensorineural hearing loss (SNHL) associated with speech-in-noise disability. The Company also has an ongoing Phase 1 healthy volunteer study for its second clinical program, PIPE-307, targeting multiple sclerosis.​

To:

Pipeline Therapeutics is a clinical-stage biopharmaceutical company pioneering the development and commercialization of first-in-class therapies for precision neuroregeneration including myelin restoration, synaptogenesis and axonal repair. The Company has a broad pipeline of programs to address CNS and neuro-otology conditions, and its flagship program, PIPE-307, has completed a Phase 1 clinical trial in healthy volunteers to support future studies in MS patients.​

Sounds like they're shifting into prioritizing PIPE-307 over PIPE-505, but it could be semantics.

 

Looks like nothing in the Pipeline here for us tinnitus sufferers unfortunately.

 

Seems like they will present the results from PIPE-505 Phase 1/2a before, or at the Inner Ear Disorders Therapeutics Summit. The event takes place 21 and 22 of June.

Source:
https://innerear-disorders-therapeutics.com/conference-agenda/day-two/

 

Just 2 more months.

 

I hope that means the results are good. But you never know lol.

Lots of companies attending!

 

This year has so far brought some interesting developments, and within the next 4 months or so, we are seeing results from at least 3 different trials.

 

Just 1 more month!

 

I don’t see Pipeline Therapeutics listed as a presenter at the June 21/22 conference.

Am I missing something here?

 

You're right, they removed it... Kudos to whoever archived the web page back in April.

https://web.archive.org/web/20220426153740/https://innerear-disorders-therapeutics.com/

 

At first sight, their speakers seems to have been replaced by Carl LeBel from Frequency Therapeutics. Weird...

 

Looks to me as if PIPE-505 did not achieve the results they had hoped for.

 

The study ended almot a year ago, I think they've known the results for a while now. But who knows.

 

These Gamma-secretase inhibitors were already used by Audion with not really fantastic results. So unless they have a complete different approach, results here will not be groundbreaking.

 

I talked to the receptionist at Pipeline Therapeutics today and they said they are releasing the results at the end of June on ClinicalTrials.gov.

 

God bless you for taking the initiative and doing that, boy did we need to hear this.

Let's hope Christmas comes early for us

 

Not sure why, but on PIPE-505’s ClinicalTrials.gov page, the company has filed for an extension to release the results of last year’s trial.

 

Where do you see that? According to ClinicalTrials.gov, they need to publish results within a year, tomorrow the latest.

 

When I clicked on the info button, it says this is done to delay submission... unless I’m missing something.

 

Do we know why? I mean, based on the description this may allow them delay submission for up to TWO years! This is probably going nowhere