Theratechnologies Inc T.TH

NGM NASH drug bites the dust

[bfw]

These results are certainly disappointing, particularly given the dire unmet need in this patient population. The lack of significant fibrosis improvement was unexpected given the consistency of histology findings previously seen with aldafermin in our adaptive four-cohort Phase 2 study,” said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. “However, in line with the data from that study, ALPINE 2/3 achieved statistical significance on multiple non-invasive measures of NASH at the two higher doses. That said, given the failure to meet the primary endpoint, we have decided to shift resources that had previously been reserved for a Phase 3 F2/F3 NASH development program toward advancing our other programs.”

[SPCEO1]

MDGL's CFO told me a while back that he viewed NGM as the biggest threat to them in NASH. So, I am surprised to see them fail so completely. It is both a positive and a negative for TH. Positive in that another NASH competitor bites the dust, negative in that it makes spending a huge sum of money on a phase III test seem even more daunting.

[Wino115]

Big news.  The other advanced Fibroblast Growth Factor guys are Akero, 89Bio, Bristol Myers - but they are FGF21, not FGF19. Not sure the differences but the overall approach is FGF and increasing adiponectin.  In some ways it's a positive for THTX.  It brings into question the FGF players above.  One less competitor and we know that while Akero has shown really good fat

[Wino115]

I guess you could add Viking to the Thyroid agonist race too.  SPCEO, any insights from the LIver Therapy analyst?

[SPCEO1]

She thinks NGM made a mistake by making fibrosis their endpoint. Frankly, I am not sure what to make of her analysis generally as she often says she has propietary info that she cannot share. 

[qwerty22]

She must be saying that because they passed the NASH resolution part, but that was a secondary endpoint. Hindsight etc. I tend to think, at least short term, that all this failure is a negative for the whole Nash sector. It gives the impression that with this difficult to treat multifaceted indication it's a bit of a coin flip on which MOA will get over the line.  I also tend to think

[qwerty22]

You sort of have to applaud the CEO here. They could have released this data Friday evening and spun things more, maybe been less emphatic about killing the program. Instead they lay it out plain and simple, time to move on. They have a backup cancer program, sound familiar?

[bfw]

thought the same thing. Except, their market cap was over $2 Billion US prior to this announcement. bfw

[jeffm34]

Their 3 mg dose resulted in a 59% decrease in liver fat. Despite this, it did not produce a 1 stage or more improvement of fibrosis.  How will TH's results be any different unless the issue comes down to trial design?   

[BlitzBuuckeyeoh]

Seems to me slowing or stopping progression would be beneficial.