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Enanta Stumbles In Trying To Show Better FXR Agonist Profile In NASH

 
• By Joseph Haas

Enanta hoped its Phase II study would indicate a better efficacy and/or tolerability profile for EDP-305 compared to other FXR agonists for NASH, including Intercept’s OCA. Despite the inconclusive data, it plans a longer Phase IIb study.

Blood sample with requisition form for liver enzyme (AST, ALT) test - Image
Enanta's NASH drug lowered ALT levels, but the fuller picture is unclear

Enanta Pharmaceuticals Inc. is one of at least six companies working to develop a farnesoid X receptor (FXR) agonist for non-alcoholic steatohepatitis that might offer a better overall risk/benefit profile than Intercept Pharmaceuticals Inc.’s obeticholic acid (OCA) – likely to be the first drug approved for NASH – but data from its Phase IIa ARGON-1 study don’t offer a conclusive case on efficacy or tolerability.

The Boston-based infectious disease specialist unveiled data on 25 September testing 2.5mg and 1mg doses of EDP-305 in NASH patients...

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Argenx Powers Ahead With Vyvgart’s Prefilled Syringe Launch

 
• By Andrew McConaghie

The Netherlands-headquartered company is enjoying huge success with Vyvgart in two autoimmune conditions, with a new prefilled syringe version reaching more patient groups.

Sanofi CFO Says Direct Sales To Patients ‘Certainly Worth Considering’

 
• By Kevin Grogan

François Roger believes fixing inefficiencies is more important than playing with pricing.

Vyne Seeks Partner For Repibresib After Phase IIb Vitiligo Fail

 
• By Alaric DeArment

The Phase IIb study failed its primary and a key secondary endpoint, but showed activity on another key secondary and an exploratory endpoint.

Blenrep Questions Won’t Go Away But GSK Sees Chance To Lead In COPD

 
• By Andrew McConaghie

GSK is sticking to its guns on its forecasts for Blenrep and the firm’s total sales in 2031 despite concerns about the antibody-drug conjugate’s approvability in the US.

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Blenrep Questions Won’t Go Away But GSK Sees Chance To Lead In COPD

 
• By Andrew McConaghie

GSK is sticking to its guns on its forecasts for Blenrep and the firm’s total sales in 2031 despite concerns about the antibody-drug conjugate’s approvability in the US.

PTC To Challenge BioMarin In PKU With Oral Sephience

 
• By Joseph Haas

PTC plans to compete with BioMarin’s two phenylketonuria drugs with efficacy data showing strong reduction of phenylalanine and ability for patients to liberalize their diets.

Lilly’s Jaypirca Threatens Imbruvica’s CLL Position After Phase III Results

 
• By Alaric DeArment

The BRUIN CLL-314 trial was designed to show noninferiority, but the p-value indicated a favorable result for Jaypirca in both the pre-treated and intent-to-treat populations.