RE:Reddit Post Question Plenty of discussion on GH and NASH through the years.
Give the poster this link...
https://www.theratech.com/wp-content/uploads/2021/01/Corporate-Deck_Theratechnologies_January-2021.pdf
They seem hypercritical as the achieved results looked non-inferior to Madrigals to me and many think they have the top prospect in the field.
bfw
MHemorrhage wrote: Had some good traction. I was able to answer everything in most subs, but might've just run into one I'll need the science-oriented ones on this board to take. From /r/biotechplays thread. Thoughts?
Other poster: Thanks for sharing. NASH is a tough indication. I'm always interested in seeing what different companies are trying.
That being said, it seems unwise to me to launch a 2000 patient, 60 month, Ph3 trial in the general NASH population based on (largely unimpressive) results from a Ph2 trial in an HIV/NASH population.
They should really run their own Ph2b in a general NASH cohort, especially since the MoA is based on HIV disruption of GH pathway, so there's no evidence that GHRH will work in non HIV patients. Kind of wild that the FDA would allow this imo.
Me: Point me where you read 60 month P3. I'm under the impression it'll be 18 months, hopefully w/ 1 arm open. And don't have enough of a science background to debate you on last paragraph, but trust that the preeminent NASH specialist in USA (Dr. Loomba) apparently was able to convince FDA otherwise. Likely along the lines of impressive (what is classified as P2 for THTX) data in HIV population already being a tougher to treat cohort.
Other poster: You're correct, 18 months to final readout, but 60 months on protocol for safety follow up. I think [HIV pop being toughter to treat] may not be true. The etiology of HIV induced lipodystrophy is more clearly understood where HIV gp120 directly inhibits growth hormone release. As far as I can tell, they haven't shown that the MoA applies for HIV negative patients.