Enanta Pharmaceuticals, Inc. ENTA announced positive top-line results from a mid-stage study on its lead product candidate EDP-305, currently being developed for the treatment of non-alcoholic steatohepatitis (NASH). This phase IIa ARGON-1 study evaluated the safety, tolerability, pharmacokinetics and efficacy of EDP-305 for the NASH patient population.
The primary endpoint of the study was to see the reduction in alanine aminotransferase (ALT), a liver enzyme, at week 12 of treatment with EDP-305 (2.5 mg). The study met the primary endpoint by achieving a statistically significant ALT reduction of 28 U/L in the EDP-305 arm (2.5 mg) compared to 15 U/L achieved in the placebo arm at week 12.
The study also met the key secondary endpoint of reduction in liver fat content as measured by MRI-PDFF at week 12 of treatment with the same dosing regimen of EDP-305.
However, around 51% of the patients in the EDP-305 2.5mg experienced pruritus or itchy skin compared to less than 10% in the EDP-305 1mg arm. There was also a modest increase in lipid levels with the 2.5mg dose compared to the 1mg dose and placebo. This can possibly be a factor why shares of Enanta plunged in after-hours trading despite the study meeting its primary and second goals.
Shares of Enanta were down almost 10.2% in after-hours trading following the above news on Wednesday. As a matter of fact, the stock has inched up 0.6% so far this year, underperforming the industry’s increase of 5.3%.
EDP-305 is a potent FXR agonist, which has exhibited strong target engagement for NASH patients. Enanta plans to initiate a 72-week phase IIb ARGON-2 study for NASH patients in the first half of 2020.
We remind investors that NASH is a chronic liver disease caused by excessive fat accumulation in the liver or steatosis. It is one of the primary reasons for liver transplants. NASH patients can develop fibrosis or cirrhosis of the liver, potentially causing liver cancer. Currently, there are no approved treatments for NASH.
Notably, biotech bigwig Gilead Sciences, Inc. GILD is collaborating with Denmark-based pharma giant Novo Nordisk A/S NVO for developing treatments for NASH. Intercept Pharmaceuticals, Inc ICPT is also developing obeticholic acid (OCA) in a late-stage study for treating patients with liver fibrosis due to NASH.
Meanwhile, apart from NASH, EDP-305 is being evaluated in the phase II INTREPID study for the treatment of primary biliary cholangitis (PBC). Enanta announced that it has achieved sufficient enrollment and there will be no further recruitment in this study on EDP-305 for the PBC indication. The study will continue in accordance with the latest data safety monitoring board recommendation.
Enanta currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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