Pipeline Therapeutics

You feel nothing but your ear being filled with liquid. Just like when water enters there. I participated in the AM-101 trial and was really scared about the procedure (intratympanic injection) and then realized it was nothing.

BTW, when is it realistic to think these drugs will be available for the general public?

 

I had no idea that you were in the AM-101 trial. Did you notice anything different with your tinnitus, was it better, worse or the same?

 

I participated being near the end of the three months time limit they set for acute stage. Thing was Christmas got in the middle of all the appointments and holidays made it impossible for me to get the injections administrated as the protocol marked. I was able to do it but the clinic was closed. A mess. Then I'll never know if what I got in the first round was the actual drug or if I fell in the placebo group.

Later, almost at my 6 months mark after onset, I received the real deal. Two rounds. Both ears. Neither improvement nor worsening. No changes at all. Just one night in between injections I experienced a couple of hours of total silence but it is something that happens to me (not for that long) right before falling asleep or waking up for a visit to the toilet. It seems sleep has some funny effects on my tinnitus.

After all and through my personal experience, I consider AM-101 to have been a total failure and a waste of funds and means.

Hope we don't go through the same story with FX-322.

 

I feel like AMPA receptor blockers would have value very acutely but I can't see it helping after that point because the glutamine surge would have done it's damage at that point. Just my opinion. I think there was probably little chance it would help long term. I personally think it would be universally helpful if given the first few weeks but since most tinnitus fades during that time it would be hard to prove without a crystal ball it was better than placebo.

FX-322 has shown to regrow hair cells in a surgically removed living cochlea and improve hearing with the small dose used phase 1. I'm way more optimistic about it.

 

I publicly declare myself a total fan and follower of your posts! Always feel gratitude for your input and keeps me feeling sober in the middle of all this confusion and suffering.
It has to be tough to remove a cochlea from its place as it sits encrusted in a thick hard boney part of our skulls. It is amazing to say the least.

 

Pipeline to present at another conference next week:

https://apnews.com/Business Wire/097dc33b8b044a729836f3cae36d994c

Hopefully, they will have news on their phase 1 trial start date.

 

I decided that I am 100% going to go for this clinical trial if they allow those who receive placebo to later receive the real deal (unlike Otonomy). I anxiously await some news on Phase 1...

 

Anyone know if their presentation at Leernik can be accessed somewhere?

 

And you, young Ben Skywalker; we shall watch your career with great interest.

 

https://www.pipelinetherapeutics.co..._Needham_Virtual_Healthcare_Conference_V2.pdf

Virtual conference that took place April 14-15. Wonder if there's any further info about it out there.

 

Watch this video: https://otomagnetics.net/about

Still in R&D

 

So I take it no one else could find a link to the substance of this talk either?

 

Pipeline are to present at the upcoming Jeffries Virtual Global Healthcare Conference on June 4. This is the same conference which Frequency Therapeutics will be presenting at.

https://finance.yahoo.com/news/pipeline-therapeutics-present-jefferies-virtual-200500356.html

 

So the conference is over, I guess Pipeline spoke at it. Does anyone know a way to find some kind of recording or transcript of the conference? Does anyone know anything about what they presented?

 

Update on Pipeline's PIPE-505 from Hearing Loss treatment report. Looks like they are about to begin recruiting for their Phase 1/2 study which was added to the ClinicalTrials.gov database yesterday.

https://clinicaltrials.gov/ct2/show/NCT04462198

 

What does this regrow?

 

It's a synaptopathy drug like OTO-413 and the Hough Pill.

I should mention too that though it os primarily a synaptopathy drug, Dan from Pipeline told me it does have some effect on outer hair cells too (probably why audiogram measurements are in the experimental arm as they are trying to work out how much).

I noticed they didn't list locations on their trial page. I wonder if this will be updated or if you have to contact the numbers listed to find out.

 

This decade is looking promising.

 

I should mention too that though ototoxins were excluded for the trial, from my correspondence with Pipeline they said they thought the drug would likely be effective for those groups but it's a more straight forward, homogenous trial to exclude those patients for now.

Unfortunately this was listed as an exclusion factor:

"Evidence of disturbing tinnitus as defined by the protocol."

Not clear why that would be the case since Hough's drug regrows synapses and was reported to help tinnitus.

I wonder if they would be amenable to being on the Tinnitus Talk Podcast so we could ask them.

@Hazel?

 

Maybe they think hair cell damage has a bigger impact on tinnitus than cochlear synaptopathy?

With that assumption people with bad tinnitus would be more likely to have larger damage in their hair cells, reducing the potential for improvement with this drug and making them bad participants for the trial.

They want the best looking results after all.

 

It's possible but I wonder, too, if it is because if there is a worsening (which could be unrelated to the drug), it may get reported as a "serious adverse reaction."

 

With a July 2021 release unfortunately... Oh well, in the grand scheme of things we should be happy we live in a time where such trials are conducted. Imagine dealing with this 15 years ago.

 

Very promising. Praying and thinking it might be sooner. Seems significant strides have been made into research around it and now firms are just trying to get it to work in the best possible manner they can.

I can say it also helps having them realize that they can make a lot of money out of it too. Think that this will be the main drier for success.

 

Tinnitus is the biggest untapped market there is. It's essentially a giant oil field waiting to be tapped. Whoever figures out the slightest way to lower the tone at at least even 50% is looking to make BILLIONS. Whether it be through a drug, treatment, or procedure.

 

Not necessarily. Now there are people showing normal hearing on their audiogram, however they indicate they have tinnitus. These cases are believed to be examples of people with synapse dysfunction. Research by Hough Ear Institute from their pill trial indicated restoring synapses (which their pill has shown to successfully do) eliminates tinnitus in individuals who have consumed it.

Obviously people with hair cell deficiency also have tinnitus so repairing these too shall also assist with tinnitus. This is because hair cell based hearing loss and tinnitus are completely related.

Regarding the trial, my view very much is companies are starting seeking out participants with lower hair loss levels deliberately. This is to see whether the treatment gets demonstrated as being effective first. We saw this with FX-322 and it was key to the breakthrough which showed the treatment worked. Once they could demonstrate this to stakeholders like FDA and financial backers, they could proceed to the current phase where they can tinker with the treatment and improve efficacy. This is because they now know that it safely works, the FDA will permit them to keep using the medicine and their financial backers are obviously giving them funds to do this cause they know there is a financial reward highly likely from a better working medicine.

So don't read too much maybe into what they do in their trials (and especially early on) as they need to start small and work up and can't look to conquer the world from the very beginning. No positive progress is no progress at all. Positive progress means good progress and a far far greater chance that there will be an available treatment.

 

Absolutely along with hearing recovery. Really since the evidence links them both, it is a double deal for whatever organisation can come up with the treatment. This will happen I am quite confident about it, it is just a matter of going through the trials and tinkering with the medication. The experts know what works, will be just a matter of refining. I think it is only a couple of years away at best because these companies want to release really in order to make the mega profit profit.

 

PIPE-505 trial is now recruiting. Recruitment Status was updated yesterday (July 20, 2020). Only one recruitment site so far (Florida). More soon, probably.

 

Interesting snippet from their press release regarding the trial:

"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. As such, we believe PIPE-505 holds significant promise as a potential therapy for patients suffering from this form of hearing loss, of which we estimate there to be some 10 million in the U.S. alone."

https://www.pipelinetherapeutics.com/news/pr_07-23-2020.php

So both synapse and outer hair cell regeneration. Sounds promising.

 

Per my correspondence with Pipeline a while back, they think it will have a minor effect on OHCs relative to the synapses but still really cool that it can do both.

 

Is it possible that tinnitus has been banned from this trial due to the fact that they want this phase to be a straight forward one? That they would be testing it as a part of phase two?