They did do speech in noise in phase 1. Page 28 of the corporate presentation shows FX-322 improved beyond placebo (20 words comprehended vs. ~2 words comprehended). This can't be a learning effect either, because of the multiple points at which they measured this variable.
If you think this is cool, you should check out the research on ATOH-1/ATOH-138 from Chen at Harvard.
Just to be clear, the data shows that participant who received FX-322 produced a 20% improvement in word-in-noise score from their baseline test (prior to receiving the dose).
Based on the licensing agreements in their most recent 10-Q, 2024 is probably a realistic year for a release if there is a typical Phase 2B, Phase 3, and NDA submission.
There is a chance but not a huge one imo, unfortunately. They have expanded their trial and are still recruiting so I'm not even sure we will still get results end of this year (though we could) because they are monitoring people 5-6 months out. They would have to be fully recruited by March for this to happen and some new locations haven't even started recruiting yet. Even if they get Breakthrough status and skip phase 3, my guess is 2022 is the absolute earliest but it would be great to be wrong.
They are in charge of all non US distribution/trials, so if/when there is a trial in Canada it will be run by Astellas.
Just listened to it. Mostly David Lucchino hitting on the same talking points on the Phase 1/2 and Phase 2A. Expectations on "how soon a product will be available" was asked by the interviewer. Lucchino commented "next few years" but depends on FDA continued support and mentioned that Breakthrough Therapy designation is not yet granted.
Just listened. The only thing new is that they confirmed they will be trying to get Breakthrough Status with FDA so drug can be released in the next few years.
The fact that they touched on our wild speculation is incredibly heartening to me. I have no idea how many hurdles they'd have to overcome if they were able to skip phase 3, but I'd guess that they'd mostly have to do with commercialization and distribution. With their robust financial backing, and assumed efficacy in dimensions previously unexamined (extended pure tone audiometry, larger dosing with possibly better delivery agent), I would suspect that phase 2 should produce better results than phase 1.
Sometime in 2022? And then add in the time for the logistics of getting the network of ENTs throughout the country learned and all fired up in the new technique. The queue (line of people waiting) will not be short.
Getting the word out to ENTs will be fairly easy. Some I have spoken to are already well aware of Frequency and Pipeline. And luckily the injection is intratympanic so nothing new needs to be learned from a procedural standpoint.
https://www.tinnitustalk.com/threads/regrowing-hairs-cells-through-dna-reprogramming.37937/
I doubt it since the FDA regulates drugs for the US but I'm not sure if there are ever exceptions to this.
Audion uses transdifferiation of an already established support cell. I'm not sure if this will be as effective as developing a fully a hair cell from the start of division.
There's really not a whole lot they can report at this time. They can't reveal any early outcomes from the Phase 2A trial, other than that they completed enrollment.
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