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SPG302 EAP from Spinogenix
Hi all,
The FDA approved SPG302 Expanded Access Program (EAP) some time in May 2025. It looks like Spinogenix has started enrolling ALS patients for this EAP. Are there any patients part of this forum that are now participating in this EAP? I would like to know about any early feedback from patients who are already enrolled and started taking this drug.
As you may know, SPG302 is a disease modifying drug and it promotes dendrite growth of the neuron and makes new synapses. This drug is expected to bring back motor functions, which is such great hope to the ALS patient community.
Wishing you all the best!
With love, NJGuy
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9 Replies
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Are they enrolling patients who diagnosed less than a year ago and already on Riluzule/ Radicava. Swallowing and Gagging progressing a bit faster.
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My understanding, from Spinogenix, is that they’re running one EAP at MGH-Boston. They are maintaining a list of those interested in participating in an EAP if/when they setup new sites. I’ve inquired on a couple of ALS Facebook sites about SPG302 in the States but no one has responded. The info from the trials (Australia) looks promising. Always hoping.
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I inquired about getting into the EAP as well and I was told the 200 spots are already taken. Hope this drug works then gets approval to go mainstream.
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Yes, this EAP is running in the USA and there are 200 spots at this time but Spinogenix is trying to get approval for 500 more patients.
Also yes, there are enrollment criteria (1 – FVC score which has to be more then 35%, 2 – should be able to swallow pills). If you are in the USA, you can request your neurologist to be in touch with Spinogenix and show your interest in taking part in this EAP. I’m pretty sure that not all 200 spots are taken at this time. There may be a chance that Spinogenix may relax the criteria to enroll but who knows that may come in the near future…
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Thank you for that info, I will contact my neurologist about staying in contact with Spinogenix.
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This is the latest information that I received from Spinogenix. <div>
Hi Leander,
We will share updates as we have them on our website, see link below.
https://www.spinogenix.com/clinical-trials/amyotrophic-lateral-sclerosis-als/
If you are interested in enrolling in the EAP, please send your treating physician and clinic name.
Best,
</div>
spinogenix.com
Spinogenix ALS Clinical Trials
We are currently recruiting for a Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPG302 in healthy volunteers and ALS participants. The trial is open in Australia and soon to be in the USA.
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I’m interested in learning more about this so I’m hoping others chime in. Thanks for posting NJguy!
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Here’s an article that I thought was interesting.
Spinogenix’s ALS hopeful to advance to registrational trial – Clinical Trials Arena https://share.google/MDBKmIcCrsfheApkR
share.google
Spinogenix’s ALS hopeful to advance to registrational trial
If Spinogenix's potentially disease-modifying drug, SPG302, were to be approved in ALS, it would join a market fraught with unmet needs.
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I have not tried the new medication SPG302
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