RE:RE:RE:RE:RE:RE:RE:RE:RE:My opinionHate to share this. Clearly these drugs are nothing to get excited about (same family of drugs as OBA) but could NASH sound any less appealing?
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Cracking NASH has been the holy grail for years in liver drug development, but the field has so far proven a wasteland for biotech. One biotech is now offloading in-house clinical work for two of its NASH drugs after one posted lackluster results as a solo therapy. Enanta Pharmaceuticals has halted internal development of its two FXR agonist NASH drugs, EDP-305 and follow-up candidate EDP-297, and will pivot to an out-licensing strategy after early data turned up little chance of success for either drug as a solo agent, the company said Monday.
"We believe that the multiple mechanisms in development for NASH today, which reflect the complex pathophysiology of this disease, make it likely that a combination approach with FXR agonists will ultimately provide the optimal treatment regimen for patients," CEO Jay Luly said in a statement.
In the short term, that means Enanta will halt its 72-week monotherapy trial for EDP-305, instead pivoting the drug into combination studies to be run by outside partners. ARGON-2, as the trial was called, tested two doses of the drug to improve NASH patients' fibrosis by one stage or greater without worsening of steatohepatitis and/or resolve steatohepatitis with no worsening of liver fibrosis as determined by liver biopsy.
That Phase II test followed early data for EDP-305 that were middling at best. In December 2019, Enanta rolled out data from a Phase I precursor study, dubbed ARGON-1, in which EDP-305 significantly cut ALT levels, a sign of worsening liver function, over placebo but just barely with a p-value of 0.049."