Yes.
- Firm plans to move FX-322 to pivotal as a single-dose drug.
- Two remaining Phase 1B trials still active, may help to further identify specific population to help with single dose (some speculate it will be the severe trial that is most revealing).
- Lucchino mentioned additional Phase 1Bs planned for 2H/2021.
I thought that the severe group would have fewer supporting cells so it would be less effective... I guess we will see.
So right now, with what we know, what is the best case scenario in a single injection scenario?
If you have almost perfect hearing with a slight loss of 0 dB to 10 dB at 8 kHz -> FX-322 might help
If you are able to hear, but have decreased word scores -> FX-322 might help
If you have hearing loss from 8 kHz to 16 kHz -> FX-322 might help
If you have super high frequency tinnitus from 8 kHz to 16 kHz -> FX-322 might help
Is there anything more we can hope for at this point?
Multiple injections spread out over months might provide additional gains in any of the items mentioned above.
Anyone feel free to correct me if I am wrong or if I missed something.
Anyone remember CGF166? Here are the results. They seem pretty similar to what we have now:
Pharma giant Novartis has suspended the clinical trials of the experimental treatment CGF166. One of the lead investigators, Columbia University's Dr. Lawrence Lustig, says, "We were not getting the results we'd hoped for."
Dr. Lustig also points out that, "A couple of patients did show noticeable improvements." Perhaps that's why the trials have been suspended but not cancelled.