Pipeline Therapeutics

I think that they are still in the middle of Phase 1/2 trials at present.

Their medicine is believed to assist with outer hair cell regeneration also.

 

Keeping an eye on PIPE-505 Phase 1/2 outcomes.

 

What is the delivery method of this drug?

 

They have said very minor effect on OHCs pre-clinically. Mostly synapses.

 

I'm not as familiar here. Is the synaptogenesis with PIPE-505 expected to work the same way as OTO-413 / BDNF?

 

No, it's a gamma secretase inhibitor, like Audion. But unlike Audion it seems to barely affect OHCs but produces prolific synapse restoration. Why this happens, I have no idea. Must be more of a partial or more (or less) selective inhibitor.

 

The results of the Phase 1/2 trial are due early 2021, right? I’m very curious what the results will be.

 

Estimated completion date is June 2021.

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

 

In their press release, Pipeline says PIPE-505 also regrows hair cells, not just synapses. Did anyone else catch that? So, it could do both things? So, if FX-322 fails, maybe this will work.

 

It seems to regrow synapses mostly, but does still regrow some OHCs. Maybe we can get FX-322, and then a couple months later get PIPE-505 if FX-322 cannot regrow OHCs.

We still don't know if spreading dosing months apart for FX-322 will allow OHCs to regrow.

 

Since we had some anecdotes for FX-322, do we have any for PIPE-505?

 

June is going to be a big month, not just for Pipeline Therapeutics, but also for Frequency Therapeutics. I'm hoping everyone is praying for the best.

If PIPE-505 works and restores hearing, then FX-322 won't matter. Whatever works.

 

June is hopefully going to be a good month. Getting both PIPE-505 and FX-322 injected in my ear is going to be so good, OHCs, IHCs and synapses will be regrown.

I do hope the FX-322 trials won’t be delayed. I’m praying for a pivotal phase when the severe hearing loss trial results come out.

 

Considering PIPE-505 regrows some OHCs (unlike OTO-413) and mostly synapses:

If PIPE-505 shows results as good as OTO-413 and audiogram improvements (if OHCs do regrow), is it better to get it rather than OTO-413?

 

I'm going to inject what I can, snort what I can't, then chase with vodka.

 

I like your approach.

 

All we need to focus on is surviving. Help is coming our way.

 

I have survived since 2007. You can too. Back then there was little interest in finding help. Things are looking up.

 

Thank you, it is looking up. Being reassured by a veteran is nice, we are going to make it.

 

Tbh I wouldn't set your expectations too high for either drug. The odds are against them and you could wind up falling on your face pretty hard.

 

I was reading the news when they mentioned about PIPE-505 starting their trials and this sentence caught my eye:

"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.”​

I’m not sure this means anything but what they implying about sensitivity sounds like OHCs could be what is causing loudness hyperacusis and noxacusis. FX-322 and PIPE-505 should complement each other as FX-322 can regrow IHCs and OHCs whereas PIPE-505 can regrow synapses.

 

If that's the case, an improvement on the audiogram and WIN test would certainly point to OHC + Synapse restoration. And, since the audiogram is the great gold standard for hearing loss, all the "skeptics" on the FX-322 thread will become #TeamPipeline overnight. Even if they aren't testing for tinnitus whatsoever.

As it relates to any sub-type / symptom bucketed under the "hyperacusis" umbrella... I honestly suspect that ANY of these treatments that restore signal to the auditory nerve, and ultimately the brain will provide some type of partial relief for any or all of the symptoms. It will depend on the individual.

 

I agree, I don’t believe in the whole only one area is causing these problems. If you fix any of these problems, whether that’s regrowing IHC, OHC or synapses, it should give sufferers partial relief.

But I hope that hyperacusis will be solved by taking FX-322 as it will be closer at coming out in the market compared to PIPE-505.

Do we know how much money Pipeline Therapeutics has to run these trials? Do they need to do something similar to Frequency Therapeutics and find a partner to help them release as they will have more money available for these trials compared to Pipeline Therapeutics?

 

Any amount of relief would be great.

 

Let's hope these next set of trials have positive outcomes. So many people are getting tinnitus or hyperacusis from COVID-19 infection or the vaccine. I hope this is treated as an urgency for these drugs to come out. Thinking about that CEO Kent Taylor who passed away because of tinnitus.

 

Who is to say though that these drugs won't lead to synapses growing uncontrollably or undirected and leading to new tinnitus or other troublesome, torturous hearing problems?

 

I believe that's a vital reason why trials exist.

 

Nobody can say for sure, however, in the imagery taken for the mouse experiments for these regenerative drugs, and here I speak generally of images I’ve seen collectively across many drug threads, the “after” picture generally more closely approximates a healthy cochlea and/or synapses, i.e. the drug is inducing a growth that visually approximates a healthy ear more closely than an unhealthy ear. We can infer from there, though nothing is certain.

 

Yeah, we will know the answers next month when they publish the results. If there are distortions in the participants' hearing, I am sure they will report it.

 

It's true. I guess the right balance of hope and being realistic will be different for everyone. Sometimes hope is the only thing that keeps some going, so there's no harm in double-dosing that ingredient.

Just read this morning about a first-ever in vivo trial of CRISPR for restoring congenital loss of sight.

With so many medical advances gaining steam lately, it doesn't seem too crazy to me to think that there will soon be viable, routine treatments for hearing issues too.

EDIT: I'd like to clarify my "it's true" assertion above. I don't know nearly enough about either drug to suspect that either will or won't work. I'd rather let the clinical studies reveal that story. My statement was meant to be in support of practicing caution in our optimism, as @weab00 seemed to be promoting.