Replies to post #247025 on Biotech Values

[Mufaso]

Including Ocliva, I suspect billions have been spent in failed NASH trials with nothing to show for it. One would think the market is very attractive given that so many keep trying.

Below is a partial list of notable drugs (I'm sure there are more) that have failed in Nash, along with MOA and trial phase completed:

 Selonsertib (Gilead)		ASK1 inhibitor		Multiple Ph 3  
 Simtuzumab  (Gilead)		Anti-Loxl2 MAb		Ph 2  
 Px-102 (Gilead)		FXR agonist		Ph 2  
 Elafibranor (Genfit)		PPARa/d agonist		Ph 3  
 Emricasan (Conatus)		FXR agonist		Ph 2b  
 Ocaliva (Intercept ) 		CETP inhibitor		Mult Ph 3  
 Seladelpar (Cymabay ) 		PPAR-delta agonist	Ph 2b  
 Semaglutide (NOVO) 		GLP-1 ag		Ph 2  
 PF-06882961 (Pfizer)		GLP-1 ag		Ph 1 
 PF 06835919 (Pfizer)		Ketohexokinase inh	Ph 2 
 NGM-219 (NGM     )		UPR inducer		Ph 2b 
 BI 1467335(Boehringer)		Pan-caspase inh		ph 2
                            

[HobGlobulin]

Nature Biotechnology on NASH Therapies

https://www.nature.com/articles/s41587-023-01787-8

[DewDiligence]

ICPT—FDA_advisory_panel_votes 15-1 against accelerated approval_for Ocaliva in NASH:

$ICPT VOTE on Q4
1-a
15-b pic.twitter.com/H4nkmYydmQ

— FDAadcomms (@FDAadcomms) May 19, 2023

In a separate question for the panelists asking if the benefits of Ocaliva outweigh the risks in F2/F3 NASH, the vote was 12-2 against with 2 abstentions.

I’ve posted many times that Ocaliva is simply a bad drug for NASH that should not be approved for this indication—e.g. #msg-169362197 and #msg-170082971.

After today’s vote, I’m skeptical that ICPT will continue its clinical trial to the final analysis for measurement for hard clinical outcomes. If they do, it'll be an extreme case of Zebra's Law.