Conatus Pharmaceuticals Inc (NASDAQ: CNAT) is having an incredibly rough start to the trading session in the pre-market hours, and for good reason. The company announced that a clinical trial failed to meet its primary endpoint. Of course, the news upset investors, sending the stock tumbling for the bottom. Today, we’ll talk about:
- The failed clinical trial;
- what we’re seeing from CNAT stock as a result; and
- what we’ll be watching for ahead.
CNAT Falls On Failed Clinical Trial
As mentioned above, Conatus Pharmaceuticals is having a horrible start to the trading session in the pre-market hours this morning after the company announced its top-line results from a Phase 2b clinical trial. The trial, known as ENCORE-PH, failed to meet its primary endpoint of change in mean hepatic venous pressure gradient from baseline to week 24 in any of the three emricasa dosing groups when compared to placebo.
In the press release, CNAT said that at week 24, changes in HVPG from baseline showed a positive trend, but were not statistically significant enough for the trial to meet its primary endpoint. In a statement, Steven J. Mento, Ph.D., President, CEO and co-founder at CNAT, had the following to offer:
Based on previous discussions with regulators, we expect that separate registration trials would be needed in compensated and decompensated NASH cirrhosis. This trial purposely enrolled mostly compensated patients, and we are encouraged by the treatment effect shown in this population in these top-line results.
The above statement was followed up by Guadalupe Garcia-Tsao, M.D., Professor of Medicine at the Section of Digestive Diseases at Yale School of Medicine, Director of the Clinical and Transitional Core at Yale Liver Center, Chief of the Section of Digestive Diseases at the Veterans Administration-Connecticut Health Care System and the central reader for the HVPG tracings in the ENCORE-PH clinical trial, had the following to offer:
Patients with compensated cirrhosis and severe portal hypertension, that is, with HVPG of 12 mmHg or higher, are at risk for decompensation, that is, they are at risk for developing complications such as variceal hemorrhage, hepatic encephalopathy and ascites that significantly decrease their quality of life and survival… We have recently shown that the risk of decompensation and death rises with progressive increases in HVPG. Conversely, reductions in HVPG as small as 1 mmHg can reduce the risk of decompensation or death. Post-hoc analyses from the ENCORE-PH trial showing that, compared to placebo, emricasan is associated with clinically meaningful incremental reductions in HVPG with worsening baseline HVPG levels, strongly suggest that emricasan has the potential of providing patient benefit.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work int he market is that the news leads to moves. In the case of CNAT, the news proved to be overwhelmingly negative. While the data may show some promise, with the primary endpoint needed, further investments of both time and money will be needed to push this asset further along the development process. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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What We’ll Be Watching For Ahead
Moving forward, the iWatch Markets team will continue to keep a close eye on CNAT. In particular, we’re interested in following the story surrounding the company’s continued work surrounding Emricasan. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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