The FX-322-111 trial is their latest trial, which they ran parallel to the Phase 2a trial. They didn't have a press release about it until today. The FX-322-201 trial is their first Phase 1/2 trial back in 2019/2020.I've been reading the press release again. I did not realise that they also released results from another Phase 1b trial. I thought this was the Phase 1b trial from 2019 but this is a completely new trial that showing meaningful improvements.
"The Company also announced preliminary results today from a recently completed open-label, single-dose study of FX-322 (FX-322-111) designed to evaluate the impact of injection conditions on tolerability. In the multi-center, randomized study, subjects with mild to severe SNHL (n=33) were injected in one ear with FX-322, with the untreated ear as the control. Hearing function was tested over the course of 90 days following dosing.
At day 90 following dosing, thirty-four percent (34%) of subjects achieved a ten percent (10%) or greater absolute improvement in WR scores in the treated ear, which was clinically meaningful and statistically significant compared to the untreated ear (p <0.05). This included a subset of subjects that more than doubled their WR scores. The single dose had a favorable safety profile and was well tolerated. These latest results are supportive of the data reported in the prior single dose Phase 1/2 (FX-322-201) study, recently published in the peer-reviewed journal Otology & Neurotology.
"We now have two independent, single-dose studies showing a hearing signal with FX-322 and with statistically significant improvements in speech intelligibility".
Which trials are they referring to when they mean FX-322-111 and FX-322-201?
FX-322 in Adults With Age-Related Sensorineural Hearing Loss
FX-322 in Adults With Severe Sensorineural Hearing Loss
The problem with their latest FX-322-111-trial is that there isn't an audiogram improvement, not even in the extended high frequencies. Carl LeBel said this today. The only hearing signal they get is the WR scores, which aren't that great and apparently can't be explained by extended high frequency improvements.