Pipeline Therapeutics

[Diesel]

I've been digging around trying to find clues about how the results of this study may turn out. I found an article from last year that had an interesting quote from their CEO: [1]

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​

The chart I showed in the OTO-413 thread indicated that the loss of synapses and OHCs seem to be the main reasons for age related hearing loss (and SNHL too). Since this drug addresses both of those, I wonder if we could see blow out results from this first study?

However, I have some concern that it's taking them so long to release the top-line results. In that article they were expecting to release the top-line results "early 2021". Their study is small, involving only 24 patients and 90 days. I can't imagine recruitment was that hard. Additionally, they raised money in February, which I find concerning. If they were confident in the results, why not wait until afterwards to raise money? Surely they'd get a better deal if they had good results.

Also, I saw that they were delivering the drug via an intratympanic injection. Anyone know if they have a special time-release gel like Otonomy?

[1] Pipeline Therapeutics Initiates Phase 1/2a Clinical Trial of PIPE-505 in Sensorineural Hearing Loss

Your concerns are unwarranted. The trial ends in June, and June hasn't even ended. These Phase 1 trials almost always go past the expected completion date, sometimes by many months. Even though its an effective treatment/assessment window that lasts 3 months, it's really more like 4-5 which includes a lead-in for scheduling the first dosage and variances in the follow-up appointments. Recruiting also takes more time than you think, because there are specific guidelines the FDA has the testing practices follow. For example, they cannot market to patients. The patient has to be in the office for a regular visit when asked to participate in a study. I would probably be a candidate given the requirements of this study... but I haven't been to my ENT in almost 1.5 years; so the stars would have to align.

Also, there's consent of the patient, "Hey we're going to inject this experimental drug into your already damaged ears, if it fucks your hearing up, sorry..." How would you approach this? Would it be beneficial if you knew there's a risk this stuff could make you worse off in the name of science?

There's a lot of work that has to go into the analytics after the readout. They need to be exact and clear, so they'll want to take an appropriate amount of time with the readout. Since they're not publicly traded, they're not obligated by the SEC / FDA to release readouts within a reasonable timeframe.

My own expectations are at the very least, they'll take until late July, early August go provide anything tangible from the PIPE-505 trial.

Link to trial page:
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss

 

[Street Novelist]

Pipeline Therapeutics updated their ClinicalTrials.gov site. It now says the trial ended June 17. So, at least we know the trial is over. I bet it's going to be awhile before they release the results.

 

[Lucifer]

Pipeline Therapeutics updated their ClinicalTrials.gov site. It now says the trial ended June 17. So, at least we know the trial is over. I bet it's going to be awhile before they release the results.

Hopefully we hear some positive results soon for the PIPE-505 Phase 1 trials. Phase 2 here we come.

 

[Tezcatlipoca]

It seems like this slipped from everyone:

Pipeline Therapeutics Appoints Scott Oross as General Counsel

New hires are always a good sign, especially this kind!

 

[Exit]

It seems like this slipped from everyone:

Pipeline Therapeutics Appoints Scott Oross as General Counsel

New hires are always a good sign, especially this kind!

Hmm, why is it a good sign they lawyer up?

 

[Diesel]

Hmm, why is it a good sign they lawyer up?

At this size of a firm it's usually pretty broad. For a firm that has probably outsourced most of its legal work, the investment is probably for regulatory compliance, business/partnership agreements, or managing intellectual property.

 

[GlennS]

Hmm, why is it a good sign they lawyer up?

We also thought hiring Hubert Lim was a good sign for Neuromod and we saw how that turned out.

 

[Jrblovsky]

I don't see why hiring anyone means a thing honestly. When they put out a working, effective product then I'll give a shit.

 

[patorjk]

This could be a non-story, but while scouring the net for clues on PIPE-505, I came across a news article (probably machine generated - but still had useful info) that says the phase transition success rate for PIPE-505 is now 56%.

So even though it seems like the study being marked as completed means nothing, apparently based on statistical analysis of how things normally go, being marked as complete increases the odds of success by 9%. So even though we still know nothing, it's more probable that there's good news rather than bad news.

 

[Lucifer]

This could be a non-story, but while scouring the net for clues on PIPE-505, I came across a news article (probably machine generated - but still had useful info) that says the phase transition success rate for PIPE-505 is now 56%.

So even though it seems like the study being marked as completed means nothing, apparently based on statistical analysis of how things normally go, being marked as complete increases the odds of success by 9%. So even though we still know nothing, it's more probable that there's good news rather than bad news.

If this phase gets positive results, they better stick with single dosing instead of multiple dosing which has been done for FX-322 and failed.

If what has shown in pre-clinical does the same thing in clinical trial they will definitely be getting positive results for this phase of the trial.

 

[Lucifer]

https://clinicaltrials.gov/ct2/show/NCT04941781



They have announced a trial for PIPE-307. Not sure what this means but this trial will start September 2021 and end in December 2021.

I wish trials such as FX-322 were this short instead of a year for each phase.

Hopefully we hear PIPE-505 Phase 1 results soon.

 

[SD7]

Any day now

 

[hopes]

Any day this year or the next one?

 

[Justin Mills]

So is the consensus that the synapses remain viable for regeneration for decades in humans so we'll be able to benefit from PIPE-505 or OTO-413 even if they take years to go on the market?

 

[SD7]

So is the consensus that the synapses remain viable for regeneration for decades in humans so we'll be able to benefit from PIPE-505 or OTO-413 even if they take years to go on the market?

Yup! Our spiral ganglion nerves are different than our mammalian cousins!

A pleasant surprise given the fact that freaking fish can recover post acoustic trauma but we can't.

 

[Foamearplugssuck]

Yup! Our spiral ganglion nerves are different than our mammalian cousins!

This is the most reassuring thing I've read in a while on here.

 

[Lucifer]

Yup! Our spiral ganglion nerves are different than our mammalian cousins!

A pleasant surprise given the fact that freaking fish can recover post acoustic trauma but we can't.

Sucks why we couldn't get acoustic trauma recovery like birds and fish.

It's nearly the end of the month. I reckon PIPE-505 results will come out either the end of this month or at the latest the middle of August.

 

[SD7]

This is the most reassuring thing I've read in a while on here.

Keep the faith

Here's the source:

https://www.entandaudiologynews.com...-conversation-with-professor-charles-liberman

There was an accompanying paper that had to do with comparing cats and contrasting them with us, but I can't find it at the moment.

Hopefully Pipeline and OTO-413 can eradicate/lessen this trash of an ailment.

 

[Nobody19]

Sucks why we couldn't get acoustic trauma recovery like birds and fish.

It's nearly the end of the month. I reckon PIPE-505 results will come out either the end of this month or at the latest the middle of August.

Please let the results be good!

 

[Damocles]

Yup! Our spiral ganglion nerves are different than our mammalian cousins!

A pleasant surprise given the fact that freaking fish can recover post acoustic trauma but we can't.

I hear that neither of the fish in this



^^^ watch with volume muted ^^^

video that @buttercake posted on his profile page, ever recovered "post acoustic trauma"...

Maybe the studies were wrong?

 

[Lukee]

I hear that neither of the fish in this

^^^ watch with volume muted ^^^

video that @buttercake posted on his profile page, ever recovered "post acoustic trauma"...

Maybe the studies were wrong?

What surprises me more is all the idiots actually working on the car with no ear pro. You'd gotta think in that line of work that these guys know what's up?

 

[Justin Mills]

It's nearly the end of the month. I reckon PIPE-505 results will come out either the end of this month or at the latest the middle of August.

It'd be nice if someone was able to get ahold of a Pipeline rep or employee to find out when we're getting any kind of results from the trial.

Also to confirm again what someone said above, yes in humans according to Professor Liebermann; "the (spiral ganglion) cell bodies and central axons can survive for decades."

In conversation with Professor Charles Liberman

So it won't be too late for any of us when a synapse regenerative drug finally makes it to market, although we might have to toil while waiting for years through the clinical phases.

 

[RichieTheKid]

What about us Non US people? I find it very hard because the trials are in the US and there's a lot of complications with a non resident getting this until it's completed.

 

[star-affinity]

I think we've touched on it before, but since this...

"Evidence of bothersome tinnitus as determined by the Investigator"

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

...is in the list of exclusion criteria for the trial, what do we think about the possibility for this drug to cure tinnitus that is related to hearing loss? Wouldn't it be interesting to have a trial with such patients too?

Maybe it will come later?

I have two other tinnitus sounds (hum/drone in head and interrupted ringing in the right ear) that I had before the onset of the latest high pitched one in the left ear. Funny how I was bothered with my previously situation, but it was nothing compared to the latest one. Also I think those two older are more difficult to fix since they don't seem related to hearing loss and acoustic trauma.

But why not give them too a go with drugs that are supposed to fix and regrow neurons and hair cells and see if it helps?

 

[Nobody19]

These companies have limited resources. They recruit patients to get the best results. They're interested in hearing loss, not tinnitus.

If the trial is succesful in their core 'audience', they might look at other conditions to treat.

 

[Justin Mills]

These companies have limited resources. They recruit patients to get the best results. They're interested in hearing loss, not tinnitus.

If the trial is successful in their core 'audience', they might look at other conditions to treat.

It doesn't matter what the target audience is. Reversing tinnitus would be an incidental effect to the main purpose of regenerating synapses to reverse hidden hearing loss. You fix tinnitus by fixing the source of it, even if that's not the main purpose. So here, the most promising solution for tinnitus happens to be a drug that targets hidden hearing loss. That they aren't targeting people with bothersome tinnitus doesn't matter.

 

[Damocles]

It doesn't matter what the target audience is. Reversing tinnitus would be an incidental effect to the main purpose of regenerating synapses to reverse hidden hearing loss. You fix tinnitus by fixing the source of it, even if that's not the main purpose. So here, the most promising solution for tinnitus happens to be a drug that targets hidden hearing loss. That they aren't targeting people with bothersome tinnitus doesn't matter.

The way I see it, it's simply a process of elimination.

Question: Does treating hidden hearing loss silence tinnitus?

Answer: We'll know once we've treated hidden hearing loss.

Conclusion: It does/doesn't. >>>

>>> Question (becomes): Does inserting Neuralink Chip inside of Human Brain silence tinnitus?

Answer: etc. etc.

Ultimately you keep playing Whac-A-Mole and the map completes itself as to where the source of the problem resides.

 

[fletchermunson]

I noticed today that PIPE-505 is listed as being in Phase 2 on the Pipeline Therapeutics website. How long has it been like this? Has there been an official announcement?

 

[Lucifer]

I noticed today that PIPE-505 is listed as being in Phase 2 on the Pipeline Therapeutics website. How long has it been like this? Has there been an official announcement?

They haven't announced anything yet about PIPE-505 Phase 1 results but this is great to see. Hopefully the Phase 1 results are positive and they can move on to Phase 2.

 

[Justin Mills]

The way I see it, it's simply a process of elimination.

Question: Does treating hidden hearing loss silence tinnitus?

Answer: We'll know once we've treated hidden hearing loss.

Conclusion: It does/doesn't. >>>

>>> Question (becomes): Does inserting Neuralink Chip inside of Human Brain silence tinnitus?

Answer: etc. etc.

Ultimately you keep playing Whac-A-Mole and the map completes itself as to where the source of the problem resides.

I disagree, we already know the overwhelming majority of cases of hyperacusis and tinnitus are caused by external insults especially acoustic trauma. We also know that synapses are most vulnerable not the hair cells themselves. It's most certainly NOT "Whac-A-Mole" to the contrary it's common sense. You regenerate the damaged synapses that cause (1) hidden hearing loss, (2) loss of sound perception clarity, (3) tinnitus, (4) hyperacusis. Then you'll fix tinnitus for the majority of people (especially those whose tinnitus is the result of loud audio exposure).