They aren't the only company doing this exact therapy.
It isn't a good one.
When I looked at preclinical for one of their competitors, that was the exact same thing, the issue was study design. Specifically, you are shoving something up an autistic kid's butt once a day or twice a day. They only did this to the placebo arm for 3 days, and only to healthy kids, whereas the treatment arm did this for 8 weeks.
If I punched you in the chest as hard as I could once or twice a day, do you think you'd have a behavioral change? That's their endpoint. If I called it a "medical" punch, does that change anything?
Can an autistic kid learn how to answer a test to get the thing to stop being shoved up their butt? I think so. By all means though, I encourage people to make this risky investment if they think this treatment pathway is real. It sort of is! If you want a behavioral change, we have a good idea of a way to get that from defenseless kids. But not for a good reason.
Given there are cases of sudden onset autism being resolved with antifungals, it’s at least not implausible that fecal transplants could be effective too.
There are so many claims of autism being cured in a couple people with different drugs or supplements out there.
They’re always followed by thousands of self-experimenters where nobody can reproduce the result.
The explanation is almost always placebo effect. A parent or doctor is so convinced that they’ve found a cure that they change assume it worked, change their behavior toward the autistic person, and believe that a dramatic change has occurred.
This is also why the placebo arm of every autism study also shows improvement.
No. No chance. It's completely implausible. This is reflected in their actual Phase II trial - NCT06503978 - whose primary endpoint is relieving GI symptoms. It's far from curing autism. It is idiosyncratic to target this population. They could do the same trial with healthy adults, but of course, twice daily massive laxatives is not something very marketable. The reason this product is the way it is is because ASD kids cannot really say no.
This seems a wild theory. So in your view, effectively abusing autistic kids results in a long-term, sustained, massive reduction in their autism symptoms? Highly skeptical on that, chief. I’d bet good money it goes the other way, and causing intentional pain and suffering in autistic kids would only worsen their symptoms.
I don’t even think I understand your proposed mechanism here. So these kids have this treatment multiple times a day, for eight weeks, and nothing they do during that time changes it, but then suddenly it stops, but they modulate their behavior for many months, what, just in case it happens again? When their behavior changes during the treatment had no effect on whether they keep getting the treatment? How does that make any sense?
> effectively abusing autistic kids results in a long-term, sustained, massive reduction in their autism symptoms?
While I'm dubious about this specific case, the basic dynamic you're describing there is the core controversy around ABA "therapy", which is effectively conditioning autistic children to act "normal" [1], sometimes through social pressure, sometimes through physical punishment that rises to a level legally recognized as torture [2]. It generally results in immediate behavioral changes, but also results in long-term PTSD [2].
I don't think you should be downvoted for expressing skepticism. I'm not going to address the details here, besides to say, I'm talking about something else.
You can read their current study, its primary endpoint is severely treatment resistant GI symptoms, not "autism". That means they are trying to get a liquid FMT with two hero laxative doses per day approved for ASD kids who have failed two other standard of care GI treatments.
But then why not get it approved for adults without ASD? It's a simple question. As you are not very familiar with the therapeutics startup business, you wouldn't know that it's all about commercialization. They are gambling that parents will buy this drug anyway, for its secondary endpoint, which is supposed to be "less disobedient behavior while ASD" (my characterization of the evaluation they receive).
Look... parents can also punch their kids, and I'm sure it'll modify their behavior. Do you see? It's not complicated, there's no conspiracy, there's barely any science.
It isn't a good one.
When I looked at preclinical for one of their competitors, that was the exact same thing, the issue was study design. Specifically, you are shoving something up an autistic kid's butt once a day or twice a day. They only did this to the placebo arm for 3 days, and only to healthy kids, whereas the treatment arm did this for 8 weeks.
If I punched you in the chest as hard as I could once or twice a day, do you think you'd have a behavioral change? That's their endpoint. If I called it a "medical" punch, does that change anything?
Can an autistic kid learn how to answer a test to get the thing to stop being shoved up their butt? I think so. By all means though, I encourage people to make this risky investment if they think this treatment pathway is real. It sort of is! If you want a behavioral change, we have a good idea of a way to get that from defenseless kids. But not for a good reason.