FX-322-208 Study Fails to Meet Primary Endpoint, Showing No Significant Separation in Speech Perception Between FX-322 and Placebo

Company Will Now Focus on Advancing its Program in Remyelination for Multiple Sclerosis (MS)

The Company will now discontinue the FX-322 development program. In addition, while dosing of FX-345, a second program to treat SNHL, has been completed in the initial safety cohort of an ongoing Phase 1b trial, that development program will also be discontinued. The Company will now focus its resources to advance its remyelination in MS program into the clinic.

This is outright horrible.

I've been following the FX-322 trial, and I'm seriously disappointed. I have sensorineural hearing loss, I might have been a good candidate for the drug if Frequency Therapeutics brought it to market.

My take on the results they've released is that the drug CAN reverse hearing loss, but they haven't yet found a protocol that gives consistent results. This is not unusual for a phase 2 clinical trial; you'd expect them to come back in a few months with a revised set of protocols to test in a new set of phase 2 trials.

But if you read the full press release and do some googling, it becomes clear that Frequency is in serious financial trouble and the CEO/founder is sidelined with serious medical issues.

From the press release:

The Company will immediately reduce headcount as part of an overall restructuring, downsizing personnel by approximately 55 percent. The Company believes that the restructuring will generate sufficient cost savings to extend its runway into 2025 and enable it to complete a first clinical trial of its MS program in 2H 2024. As of December 31, 2022, Frequency had cash, cash equivalents and marketable securities of $83.1 million (excluding restricted cash).

So the company isn't stopping the hearing loss drug trials because it doesn't have potential. Rather, they're venture-funded and running out of cash. They've stopped ALL their research except for the work on this one MS drug, because they think they can get it through clinical trials and sell it before their money runs out.

In the short term, this is bad for us. In the long term, there's still hope, because cash-strapped Frequency may sell the rights to the hearing loss drug to somebody else who could actually finish the trials and bring it to market.

Here's hoping.

https://hms.harvard.edu/news/scientists-regenerate-hair-cells-enable-hearing

First of all thank you, as I know Decibel Therapeutic is far away from cure, Rinri said it take 8-10 years, Sound pharmaceuticals SPI 1005 is for Meniere and acute hearing loss, the other I didn’t know until now. So like you said it’s cure will be available sometime the hard question is when 5/10/20 years or more