Patient enrollment for Frequency's FX-322 Phase 2a study has been steady over the second quarter of 2020 and based on current projections, the Company expects to achieve target enrollment by early in the fourth quarter of 2020. Based on this timeline, the Company expects to report study data in the second quarter of 2021. [1]
The study is 7 months long, so if we assume the last person gets entrolled in late October, then the study should complete in May. That means we'll probably see top-line data sometime in late May or early June. I'm glad they're doing things right, but that just seems so far away.
This also means that the results of Phase 2a will happen very close to their Multiple Sclerosis drug submission, which is a little interesting.
They listed some conferences they'll be speaking at this fall, but it seems like there's going to be a drought in news from them between November of this year and May of next year. I wonder what they'll do during this time period.
Four of the patients that were observed to have statistically significant WR scores during the Phase 1/2 study were observed to have maintained the hearing benefit, three of which remained at statistically significant levels. An additional patient who did not achieve a statistically significant improvement in WR during the Phase 1/2 study was also retested and it was observed that the WR score had returned to baseline. The Company plans to share results of this follow-up study at the upcoming American Academy of Otolaryngology – Head & Neck Surgery meeting in September 2020. [1]
I am mildly concerned about people returning to base-line. However, looking at the slides, even people in the Placebo group improved [2, slide 22]. I wonder if some of the improvement that was seen was due to just getting better at the test. If you do something every 30 days, you're bound get a little skilled at it, but after a year, you're probably back to normal. I'm hoping that's the case and we're not seeing that these haircells don't last. The fact that they're presenting their data at a conference is a good sign. It'll be very interesting to see what the data shows.
[1]
https://frequencytx.gcs-web.com/new...tics-provides-business-updates-and-reports-2/
[2]
https://investors.frequencytx.com/static-files/6d161090-16f5-49f4-9606-8caceb5a88a1