CNM-AU8 Trial

[JAM]

I’m sorry Nikki. You have suffered so much loss in your lifetime. I wish I could take all that pain away and pray these recent advances in FALs treatments help bring it closer to an end for all

 

[Mg8]

Same via Synapticure. First dose this past Tuesday.

 

[Kclark]

My husband is looking for a trial and we are at the va in Chicago. Please keep us posted

 

[JAM]

Have you checked the clinical trial website? It’s very helpful in area, phase, etc. I am an hour north of Chicago. I reached out a month ago to Northwestern about a trial there but they were using patients from their clinic first. In hindsight I wonder if we shouldn’t have changed clinics? Our clinic doesn’t ever seem to know much about trials, new medicines etc. but the people at the clinic are so kind.

 

[Nikki J]

It is possible to attend two clinics. Both my sister and a friend started with clinics near their homes but added mgh. They both dropped the home clinic after a year or so but not because they had to. Their original reason for mgh was another opinion but they liked it so much they stayed

 

[lgelb]

Here is the interventional trial search link -- you can fill in your location.

ClinicalTrials.gov

clinicaltrials.gov

 

[powerpadman]

Very interested in hearing any early results or perceived results for those who got
Into the CNM Au8 EAP. My brother is on the list through Synapticure but I don’t think he is going to make the cut (not enough spots).

 

[JAM]

Yes, if anyone currently is taking please let us know. We understand that whatever you’re feeling observing does not prove anything one way or the other, still we’d love to hear any news/updates even if they are that nothing is happening

 

[ahl39]

Synapiture told us they filled all 70 spots already.

 

[SMJgal]

JC2024 - I am participating in EAP02 for CNM-Au8 here in Washington state. I started June 2024 and am also hopeful!

 

[JC2024]

Hello All,

I have been taking CNM-AU8 for going on 6 weeks now. Do I notice any difference I think it is to soon at this point to tell. I'm going on my third year with symptoms of ALS it took 3 year to get to this point so it may take a little time to truly see results. I have my next appointment with my team in 6 weeks. I get a 3 month supply at every visit.

If there is anyone who has been taking it longer please give us your opinion on how you feel it is working. I will keep you updated on my progress

 

[JAM]

If I’m not mistaken Cline is hoping to convince FDA for a ph 3 and AA depending on additional NFL measures in the study. Does anyone know when that will happen? TIA

 

[Nikki J]

It will depend on how long it takes Clene to collect the data, prepare their submission and then the fda would schedule a meeting to discuss. If they were allowed to submit for accelerated approval they would probably have to do a new application which would be thousands of pages. The fda then reviews and then often there is a public meeting ( both relyvrio and qalsody had them) called an ADCOMM where the fda scientists presents their assessments and the drug company replies to any concerns. There is also time for public testimony then there is a vote by a panel of neurologists there is also a citizen member of the panel. The vote is only a recommendation and the fda can decide differently
Even IF Clene is successful we aren’t going to see it on the market for many months

 

[JAM]

Ty Nikki. That is quite a detailed process - which I know is good since it needs to be thoroughly investigated before being allowed to go forward. Still keeping fingers crossed for positive results.

 

[lgelb]

If all goes well, they plan to get P3 started and then file the NDA mid-year under the accelerated approval pathway. The traditional consideration process takes several months at least; with new FDA leadership and a stated policy shift, I would not venture a guess right now as to what happens post-NDA.