Positive Results From KALM-1 Pivotal Phase 3 Trial of KORSUVA™
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So what
Any time a clinical-stage biotech announces positive results for its lead candidate, it's good news. But today's results are especially great for Cara for several reasons.
The improvement in itching for patients receiving Korsuva was off the charts. The key metric in determining statistical significance in clinical studies is the p-value, a calculated probability of how meaningful the obtained results actually are. A p-value of 0.05 or less is considered to be statistically significant. For the primary endpoint in Cara's study, the p-value was 0.000019.
Cara Therapeutics CEO Derek Chalmers noted that the company was "particularly encouraged by the early response with Korsuva injection." He said that the statistically significant difference between Korsuva and placebo was observed after only one week of treatment. Even better, the significant benefit from Korsuva was sustained through 12 weeks.
Also, Korsuva didn't raise any safety concerns. There were some adverse events for patients in the phase 3 study, but they were similar across patients taking Korsuva and those on placebo. The most common adverse event was diarrhea, which was reported for 9.5% of the patients receiving Korsuva injection versus 3.7% of the patients in the placebo group.
Now what
This was a critical step for Cara, but there are still a couple of hurdles to jump. The biotech must complete another ongoing phase 3 clinical study of Korsuva injection in treating CKD-aP patients on hemodialysis. Cara expects to announce the results from this second study later this year. If those results are positive, the company will move quickly to file for U.S. regulatory approval of the drug.
There's no sure thing when it comes to the regulatory approval process. But based on what Cara announced today, the chances of eventual approval of Korsuva in the CKD-aP indication appear to be quite good.
finance.yahoo.c...-153608796.html?.tsrc=rss
So what
Any time a clinical-stage biotech announces positive results for its lead candidate, it's good news. But today's results are especially great for Cara for several reasons.
The improvement in itching for patients receiving Korsuva was off the charts. The key metric in determining statistical significance in clinical studies is the p-value, a calculated probability of how meaningful the obtained results actually are. A p-value of 0.05 or less is considered to be statistically significant. For the primary endpoint in Cara's study, the p-value was 0.000019.
Cara Therapeutics CEO Derek Chalmers noted that the company was "particularly encouraged by the early response with Korsuva injection." He said that the statistically significant difference between Korsuva and placebo was observed after only one week of treatment. Even better, the significant benefit from Korsuva was sustained through 12 weeks.
Also, Korsuva didn't raise any safety concerns. There were some adverse events for patients in the phase 3 study, but they were similar across patients taking Korsuva and those on placebo. The most common adverse event was diarrhea, which was reported for 9.5% of the patients receiving Korsuva injection versus 3.7% of the patients in the placebo group.
Now what
This was a critical step for Cara, but there are still a couple of hurdles to jump. The biotech must complete another ongoing phase 3 clinical study of Korsuva injection in treating CKD-aP patients on hemodialysis. Cara expects to announce the results from this second study later this year. If those results are positive, the company will move quickly to file for U.S. regulatory approval of the drug.
There's no sure thing when it comes to the regulatory approval process. But based on what Cara announced today, the chances of eventual approval of Korsuva in the CKD-aP indication appear to be quite good.