Genfit's elafibranor flunks NASH study; shares plummet 42% after hours

• Based on an interim analysis, a Phase 3 clinical trial, RESOLVE-IT, evaluating Genfit's (NASDAQ:GNFT) elafibranor in adults with nonalcoholic steatohepatitis (NASH) failed to achieve the primary endpoint.
• Elafibranor did not sufficiently separate from placebo as measured by the proportion of patients achieving NASH resolution without worsening of fibrosis at week 72. Based on an intent-to-treat population of 1,070 patients, the response rate in the treatment group was 19.2% (n=138/717) compared to 14.7% (n=52/353) in the control arm.
• The proportion of patients achieving improvement in fibrosis at week 72, a secondary endpoint, was 24.5% in the treatment arm versus 22.4% in the control arm.
• The full dataset will be presented at a liver meeting in H2.
• Shares down 42% after hours.
• Selected NASH-related tickers: Intercept Pharmaceuticals (NASDAQ:ICPT) (+3%); Galectin Therapeutics (NASDAQ:GALT) (+12%); Viking Therapeutics (NASDAQ:VKTX) (-3%); Can-Fite BioPharma (NYSEMKT:CANF) (-1%); Lipocine (NASDAQ:LPCN) (+4%); Bristol-Myers Squibb (NYSE:BMY) (-1%)

Comments

[share_maverick]

Time and time again it has been proven that you cannot put lipstick on a pig and in this case justify a failed phase 2 trial.
Targeting metabolic component of Nash will not do much and you have to treat fibrotic component and that too patients in late stage.
The only company still standing is ICPT and they are barely given the tox profile of their drug. I am an investor in ICPT but I don't think anything except MDGL will come closer. If ICPT have good marketing strategy and their drugs get approved they may get 15-20% of NASH and all in late stage. I suspect that is where they will be targeting.

Don't be a fan of any stock. be objective and take your positions wisely.

[DSGX1]

Can't talk about MDGL without including VKTX.

[Dan Komaromi]

GALT is the best horse in the NASH race now -- belapectin is the only direct anti-fibrotic that has shown actual clinical effect (not just lab results): the prevention of bleeding varices. GALT simply needs to repeat the effect already demonstrated in Phase 2, where the prevention of varices was statistically significant (also decreased HVPG).

Perhaps best summarized in this recent paper published in the journal Gastroenterology:

"Modulation of Fibrogenesis Even when effective therapies for preventing and treating NASH are available, many patients will continue to progress without symptoms and present to physicians when they already have advanced fibrosis. Thus, there will always be a potential clinical role for therapies that can reverse fibrosis by directly blocking stellate cell activation, decreasing extracellular matrix production, and increasing its removal.181"

"Directly antifibrotic drugs include molecules that block the galectin-3 receptor on stellate cells.182,183 A study of one such drug, belapectin (GR-MD-02), was shown to reduce the hepatic-portal vein pressure gradient in patients with cirrhosis but without varices184 (NASH-CX, NCT02462967), and a further trial of belapectin is in development."

www.gastrojournal.org/...

[NDHT]

I'm in at $7 for the following reasons:

1. Their Phase 2 trial PBC is quite positive.

2. They have 277 million in Euro in cash, close to their market cap now?

3. They have a unique diagnostic test (non-biopsy, or no piercing through the liver to get a piece of it) for NASH, which is partnered with Lab Corp., a good validation.

4. They have initiated a combination study for NASH. Elafibranor alone and over a short period of time may not show clear effect, but as a combination, which is the future standard of care anyway, it may work.

5. They have another molecule in Phase 2 study now for fibrosis.

Any disagreements?

Shoot!

[skwirrlmaster]

lol how is this Eurotrash bio only down 40%? This crap should be down 140% for wasting everybody's time after flunking the phase 2 then scamming folks with their bullshit post-hoc subgroup nonsense.

[jbdash2]

Anyone buying at $7 and change? Is this the only product in their pipeline?

[CR144 Research]

ICPT may benefit from it

[microhoo]

Bummer.

[Downtown10]

NASH; where biotech investment dollars go to die. It got some of mine before I wised up.

[vtcarguy81]

Take a look at the research $LPCN has been conducting. Best value in NASH IMO

[Fattyliverman]

As far as winners and losers in NASH, that shows a very rudimentary understanding
The economic and human toll in NASH is late stage, compensated Cirrhosis becoming decompensated leading to complications, liver transplant and HCC
The American Journal of Gastroenterology in April 2020 listed a Medicare study of those economic costs
NASH is a very difficult disease to crack because of the multiple metabolic pathways and environmental factors
I have always favored a direct acting antifibrotic as the answer for late stage, where metabolic issues are no longer in play and it’s the end stage fibrosis leading to F4 and beyond
GALT stands to gain from this PPAR debacle

[Pseudopseudonym]

That’s like saying the best way to treat chronic kidney disease is to wait until esrd and use dialysis.

[Fattyliverman]

I understand your point, but what you don’t realize is that no drug can stop the metabolic pathways in NASH
Diet and exercise won’t happen, and ICPT data showed an effect in only 1/5 people
In the overwhelming majority the disease will march on, and we can only help to prevent complications
There is no cure for NASH. This isn’t HCV
Now your analogy is not exactly correct. If in CKD we can find a drug that forestalls dialysis, that would be a more exact analogy
With GALT we are trying to prevent end stage liver complications - equivalent to dialysis in renal failure patients

[Pseudopseudonym]

I also get the error in my analogy but was trying to make the point which I think you do get (and agree with). The more “upstream” one goes in the pathological pathway, the better.

I’d disagree re your second point. I *might* be mistaken but I think that Metformin has been shown to reverse histology nash. I also wouldn’t be surprised if SGLt2 inhibitors and or GLP1 agonists did the same, they just haven’t been studied as such. If I’m wrong, I preemptively apologize :)

[Fattyliverman]

I think you are confusing me with nashbiotechs. That’s the French guy who ran the website on all NASH stocks

[stephen tips]

BTW: I am curious to know how @fattyliverman sees these results, considering his constant belief that GNFT was the sure winner for NASH.

Surprised no comments.

[srg045]

Don't hold your breath...

[Statham]

42%.... ouch.

[ATinvestor]

It looks good for $GALT!

[braliv]

Sory 13,6%

[braliv]

MADRIGAL TO DAY WAS UP 12%

[Axomoxa]

why? is Heisenberg cooking again?

[stephen tips]

With ICPT adcomm on 6/9/20, and the PDUFA on 6/26/20, this unfortunate setback for GNFT appears to assist the probability of approval for Intercept Pharmaceuticals.

Long $ICPT (first-to-market in NASH?).

[srg045]

This shouldn't surprise anyone. They were supposed to release this data months ago.

[Max Zar]

Madrigal

[maverick451]

Long Live VKTX