Shares of Cara Therapeutics (CARA) are up 25% after the company reported positive phase 2 results in patients with kidney failure. More specifically, Cara's drug treats a condition these patients have, known as Uremic Pruritus, which causes severe itching that interferes with daily life activities. There are no currently approved FDA products to treat this condition, therefore a drug with this type of observed efficacy is welcomed hope.
Now that Cara has these positive phase 2 results on hand it will have to meet with the FDA to draft an appropriate phase 3 trial design that will be used for the possible approval of the CR845 drug. If all goes well wit the FDA meeting, the company then expects to begin a phase 3 trial sometime in 2016.
The phase 2 trial enrolled up to 65 dialysis patients who had severe itching because of Uremic Pruritus. The primary endpoint was to determine a change from baseline in the amount of itching during the second week of treatment using a scale known as VAS — visual analog scale. Patients who took CR845 saw a 54% greater reduction in itching compared to those patients who were on the placebo. Now all that is left is for Cara to take this to phase 3 clinical trials to ultimately seek FDA approval to help these patients.