Theratechnologies Inc T.TH

RE:RE:RE:RE:RE:RE: PLWH and Nash

[juniper88]

"(which they didn't) "  QWERTY, that is just your assumption.  True, no deal was made but that doesn't mean there was no interest.  Maybe something was on the table but not on terms acceptable to Thera.  We can see how good Thera's negotiation skills have been over the last couple of offerings.

Qwerty54321 wrote:

I'm not convinced there is a HIV-only path because I don't think you exclude hiv patients from the other drugs. The problem for THTX is/was how do you pivot to the general population on the back of hiv data. They messaged they were shooting for the moon with a straight ph3 and got pretty close with a Ph2/3 that still had an hiv component. That's still a bit messy but a great achievement. If they had had the money, time and interest from others (which they didn't) then they'd have been dosing a straight Ph1/2 in the general population to put them on the right path. One way to look at this might be to think of them pushing the fda as far as they could with this hiv data as a way to prove that taking a step backwards into the general population was worth the risk. If the hiv is an ugly duckling then the got the fda to admit it has the potential to be a swan. I come to that position because I've always thought they need more data than they have to justify this as a Ph2/3 drug in the general population, I could easily be wrong on that. The way the NASH field developed meant I don't think too many were looking for that sort of opportunity.

From memory, the great thing about mdgl's drug is it has downstream activity a bit like THTX's. If there is a feeding frenzy around NASH opportunities then maybe we snag something.

Lee430 wrote:

Palinc2000, it seems that we interpreted the FDA push for Thera to trial the general population & not just PLWH as a positive indication of support, however, in hindsight it seems to have been a disaster for the program as it is possible we could have been approved by now for the HIV population if we were not pushed down the wrong rabbit hole.
 
Is this that way you see it also?
 

Qwerty54321 wrote:

I can't see any restrictions. The exclusion was to keep the trial as simple as possible. Most drug trials do that. Hiv patients aren't then excluded from those drugs.

palinc2000 wrote:

If HIV patients are diagnosed for Nash they would not be prescribed the Madrigal drug?

scarlet1967 wrote:

Exclusion criteria

Patients who meet any of the following criteria will be excluded from participation in the study...."

Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, who are known to be positive for HIV or who have recurrent or chronic systemic bacterial, fungal, viral or protozoal infections."

https://www.nature.com/articles/s41591-023-02603-1

I don't believe they had any HIV positive patients enrolled in their trial like most of the current trials.

 

palinc2000 wrote: We were told a few years ago that FDA insisted that THTX proposed Phase 3 trial include the general Nash population and not only PLWH .....In hindsight that was bad news since THTX could not handle such a large trial

Does anyone have access if any to the subset data from the Madrigal trial on results in theur Phase 3 trial for PLWH?
Scarlett and or Qwerty are the only posters imo on this MB who could find out  but of course others are invited also
Maybe just maybe there could be an opportunity for going back to the original Nash protocol to include only PLWH