Small-cap biotech Cara Therapeutics Inc CARA is trading to its highest level since early April after it released the results of a Phase 3 trial for its lead candidate Korsuva.
What Happened
Cara, which focuses on developing new chemical entities for treating pruritus, a severe form of itching, announced positive top-line data Wednesday from the KALM-1 pivotal Phase 3 trial of Korsuva injections in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritis, or CKD-aP.
Korsuva — chemically difelikefalin — acts by selectively targeting peripheral kappa opioid receptors.
Korsuva achieved the primary endpoint of the trial, with the proportion of patients receiving 0.5 mcg/kg of Korsuva achieving a three-point or greater improvement from the baseline in the weekly mean of the daily Worst Itching Intensity Numeric Rating Scale score at week 12 at 51 percent compared to 28 percent for patients on placebo.
The investigational asset also met key secondary endpoints. It was generally well-tolerated, with a safety profile consistent with earlier Korsuva clinical trials.
Why It's Important
Korsuva is Cara's only clinical asset. It's being tested in different formulations for indications such as pruritis and chronic pain.
The company cited estimates that suggest that at least 40 percent of patients with end-stage renal disease suffer from pruritis.
The FDA has granted Breakthrough Therapy Designation for Korsuva injections in CKD-aP.
"We are extremely pleased with the robust topline results from our first pivotal Phase 3 trial of KORSUVA Injection and are particularly encouraged by the early anti-pruritic response with KORSUVA Injection, which resulted in statistically significant separation from placebo after only one week of treatment and a sustained significant benefit through 12 weeks," Cara CEO Derek Chalmers said in a statement.
What Next
Cara said it expects to report topline data from its second global Phase 3 trial, KALM-2, in the second half of 2019.
If the results are positive, Cara said it will likely follow a New Drug Application shortly thereafter.
Cara shares were trading up 12.85 percent at $20.29 at the time of publication Wednesday.
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