[sosuke]

For the sake of my question let’s assume this is legit and magically works for a wide range of autoimmune conditions. How many years away are we from being able to sign up for this treatment? 10 years? 20? 30?

It would be nice to dream of it happening sometime soon.

[thebeardisred]

In the US, my "back of the napkin" estimate tends to be 8-15 years, if it passes trials.

[kiba]

Is there a way to speed up trials without compromising quality?

[throwup238]

Only for orphan and ultra orphan diseases where there are so few patients that it’s not economically viable to do full clinical trials.

There is also a breakthrough therapy designation where the clinical evidence is solid enough to release the drug while they finish full trials but that’s only in exceptional cases.

[adamredwoods]

Possible to use surrogate endpoints, which is used for slower evolving diseases. But then the claims need to be associated with the new endpoints.

FDA can fast track certain drugs, but it really needs to show amazing efficacy.

[Retric]

Not really, the process gets shortcut when the benefits of moving fast are dramatic enough.

So sure we could speed things up by killing more people undergoing medical experiments. But the current approach of validating safety in humans then efficacy in humans is inherently serial. Further a lot more stuff is going into the pipeline than actually ends up working.

[andrewjl]

https://www.outsourcedpharma.com/doc/an-overview-of-the-fda-...

[notheyarent]

Only for gene therapies unfortunately

[mhuffman]

Maybe not long at all. Scroll down to the section that says "Our Approach : Building a Designer Immune System" on this site[0]

[0]https://orcabio.com/what-we-do/

[wpasc]

amen. I've tried 3 tnf inhibitors that have not worked (and had negative side effects). Cosentyx (il 17a inhibitor) kinda scares me. I always like to keep my hopes that some better autoimmune treatments could come soon

[throw241005]

Out of curiosity I'm curious why it scares you?

For context, I had been on Taltz before for psoriasis, and it worked very well. It seems like il17 inhibitors specifically are extremely targeted in what they affect.

In comparison, I was also on otezla at one point (tnf-a inhibitor) and it didnt work for me either, and the side effects were terrible.

[wpasc]

It's the few instances of new onset IBD and generally the GI side effects. I'm lucky enough to have a pretty solid GI system that I don't want to risk messing with. I get very anxious with medicine, and my ankylosing spondylitis is sufficiently slow moving on MRI and tolerable enough that I prefer not to use the medicines. I had too many strange side effects whilst on Humira/Remicade such that it scares the crap out of me.

[throw241005]

Understandable. I'll just say that for a sample size of n=1 I've seen no GI side effects with il17 blockers.

Which was not the case with otezla. But tnfa blockers - yeah those are bad times.

In any case, good luck with your treatment!

[wpasc]

thank you and thanks for your n=1, wish you the best with your treatment as well

[notheyarent]

You had a skin fungal infection dumbass not some unknown mystery condition psoriasis they came up with

[throw241005]

Wow, kid, you really have no clue about the world.

[dylan604]

Depends. Do you want to be a patient, or a trial test subject?

[9dev]

I would assume they primarily would like to suffer less.

My uncle has developed an autoimmune respiratory disease over twenty years ago, and I know he would give a whole lot to improve his condition.

[tim333]

Probably less long if you are prepared to go to China where the research in the paper took place. The FDA seems to be a bit slow.

[hammock]

In Mexico, maybe a year?

(Please don’t downvote me because you don’t like the tone of that. Europe banned artificial food colors and Japan is using self-replicating RNA vaccines. There is a wide spectrum of risk tolerance and healthcare does not revolve around the USA)

[gus_massa]

I'm not sure about Mexico, but here in Argentina I think we wait until the drug gets a the FDA or EMA approval and ask for a copy, well we probably ask for all the paperwork but I don't remember cases of weird fast local approvals. It's possible to buy Metamizole/Dipyrone here https://en.wikipedia.org/wiki/Metamizole . Anyway, we have special cases, like a vaccine for a local illness https://es.wikipedia.org/wiki/Virus_Jun%C3%ADn that I guess is not approved anywhere else.

Every few years, there is an scandal for illegal medicine, but I think most of the case it's about using industrial silicone in human cosmetic surgery or something as stupid like that, not cutting edge new drugs. Perhaps it's possible to get tourist-illegal-medicine, but I strongly advice against that.

---

> Japan is using self-replicating RNA vaccines

Do you have a source for that? I can try to take a look. I suspect it's very bad journalism reporting.

Self-replicating RNA are just https://en.wikipedia.org/wiki/Viroid but they only survive in plants, not animals. If they make their own coating, they are retrovirus. Writing a retrovirus from scratch is too difficult, some vaccines use edited virus, where they add the interesting part but also remove another part to the virus can't reproduce outside the lab. And there are vaccines with "live" attenuated virus, like the oral polio vaccine, but they are more difficult to make.

[hammock]

https://www.prnewswire.com/news-releases/japans-ministry-of-...

Your characterization is inaccurate, of both the reporting and the technology

[gus_massa]

Thanks. Very interesting. From the research paper:

> The ARCT-154 study vaccine consists of sa-mRNA encapsulated in lipid nanoparticles. The RNA comprises a replicon based upon Venezuela equine encephalitis virus (VEEV) in which RNA coding for the VEEV structural proteins has been replaced with RNA coding for the full-length spike (S) glycoprotein of the SARS-CoV-2 D614G variant.

IIUC the RNA makes copies of itself inside the cell, but it does not get a capsule of proteins to travel and invade other cells. Is this correct?

(A few more details in https://en.wikipedia.org/wiki/MRNA_vaccine#Amplification but not enough for my curiosity level.)