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Conatus May Still Have A Path Forward After Latest Phase 2b Data

Dec. 07, 2018 8:50 AM ETHistogen Inc. (HSTO)NVS58 Comments


  • Conatus Pharmaceuticals didn't meet primary endpoint for phase 2b ENCORE-PH study, but a subgroup analysis of compensated cirrhosis patients had a clinically meaningful effect when taking emricasan.
  • Those that benefited the most with 25 mg emricasan were compensated NASH cirrhosis patients with portal hypertension that had HVPG ≥13 mmHg.
  • Both the 25 mg and 50 mg of emricasan achieved a >10% improvement in mean HVPG compared to placebo in all HVPG cohorts from ≥13 mmHg through ≥17 mmHg.
  • Additional 48-week data from the phase 2b ENCORE-PH study measuring liver function and other clinical outcomes is anticipated by mid-2019.
  • Results remain for two other studies, which are ENCORE-NF in NASH Fibrosis due 1st half 2019 and ENCORE-LF for NASH cirrhosis due by mid-2019.
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Recently, Conatus Pharmaceuticals (CNAT) announced results from its phase 2b ENCORE-PH study treating patients with NASH cirrhosis portal hypertension. The primary endpoint for the overall trial wasn't met. However, I believe that the company still has a path forward for a subpopulation of compensated cirrhosis patients. This could potentially be moved forward on a subgroup analysis. For this reason, I believe that the study may still push forward. On top of that, there is another 6-month treatment extension period that will look at other clinical outcomes besides HVPG as an endpoint.

Further Potential

The phase 2b ENCORE-PH study recruited a total of 263 patients with compensated or early decompensated liver cirrhosis and severe portal hypertension. Patients enrolled into the study had to have an HVPG > 12 mmHg at baseline. Patients were randomized to receive either 5 mg, 25 mg, 50 mg of emricasan or placebo twice daily for 24 weeks. It was announced that the primary endpoint of achieving a change in the mean hepatic venous pressure gradient (HVPG) from baseline to week 24 was not achieved. Despite this, there was a subgroup analysis done on compensated cirrhosis patients which may provide a path forward towards additional studies. A post-hoc analysis showed that there were consistent improvements in mean HVPG at week 24 over baseline in the compensated cirrhosis population. Clinically meaningful differences compared to placebo were shown consistently in multiple baseline HVPG cohorts from ≥13 mmHg through ≥17 mmHg. These values are shown below:

Patient Baseline HVPG Emricasan 25 mg BID
≥13mmHg -1.4 (p=0.040)
≥14mmHg -1.8 (p=0.015)
≥15mmHg -1.6 (p=0.035)
≥16mmHg -2.3 (p=0.006)
≥17mmHg -2.8 (p=0.005)

Notice above that it starts off with ≥13 mmHg and goes higher. That's because the >12 mmHg total population (both compensated and early decompensated patients) was not significant with a p-value of p <0.05. The

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This article was written by

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Actionable ideas on small-large cap biotech stocks through deep analysis.

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