SPG302 EAP from Spinogenix

[virgo777]

Are they enrolling patients who diagnosed less than a year ago and already on Riluzule/ Radicava. Swallowing and Gagging progressing a bit faster.

[FAITH OREMLAND]

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.

[Jeff-Y]

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.

[NJGuy]

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…

[Jeff-Y]

Thank you for that info, I will contact my neurologist about staying in contact with Spinogenix.

[leander]

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.

[Amanda]

I’m interested in learning more about this so I’m hoping others chime in. Thanks for posting NJguy!

[leander]

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.

[Esmeralda Trinidad]

I have not tried the new medication SPG302

[katy1985]

I have an appt for a screening in Feb. I have read that Dr Rowe from the Australian trials was positive about results in slow progressors but said it did not work in fast progressors.

[leander]

Katy,

Please keep us posted.

[Jeff-Y]

Hello Everyone, I just started on SPG302 which is being administered through MGH in the EAP. Though it has been only 1 week on it, I am not experiencing any adverse events. If you would like to know more, you can text or call me at (518) 221-2826.

[katy1985]

Thanks, if all goes well at the screening I am supposed to start the meds early March. We are working the timing around a long planned Europe trip in June. To keep me on schedule for the follow ups. I will keep in touch .

[Monica]

I enrolled in SPG302, in spite of my doctor’s opinion. My neurologist advised against it because of lack of data. After a few days of taking the drug, I became nauseous with a migraine headache. It was so bad I ended up in the ER. I stopped taking the drug for 10 days and decided to try again. The headache and vomiting returned. I withdrew from the EAP. I also saved myself $6500 because the cost is being passed onto patients.

[katy1985]

Thank you for posting your experience Monica.