According to a news release from Biospace, recent data from the KALM-2 Phase III trial highlighted how Korsuva, an injectable, is beneficial in treating severe itching associated with severe chronic kidney disease. The medication from Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) had similar results from the KALM-1 Phase III trial.
Chronic Kidney Disease
Chronic kidney disease (CKD) is a condition characterized by progressive damage to the kidneys. Normally, the kidneys filter waste from the blood. This waste is then expelled from the body during urination. However, chronic kidney diseases causes this waste, including fluid and electrolytes, to accumulate in the body. Symptoms include high blood pressure, jaundice, inflamed and enlarged organs, fatigue, vitamin deficiencies, and severe, persistent itching. In fact, itching is present in an estimated 40% of dialysis patients. Additionally, the itching happens with patients with chronic kidney disease who are not on dialysis.
There are many causes of chronic kidney disease. These include diabetes, recurrent kidney infections, high blood pressure, and kidney inflammation. Learn more about chronic kidney disease.
VFMCRP bought the worldwide licensing rights to Korsuva (minus Japan, South Korea, and the United States) 2 years ago. Meanwhile, Cara Therapeutics has the rights to commercialization and drug development within the United States. Korsuva received the Breakthrough Therapy indication for its results in May of 2019. According to the FDA, Breakthrough Therapy indication means that a therapy:
intend[s] alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition, and…preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
The KALM-1 trial showed clear benefits throughout the entire 12-week study, particularly in comparison to placebos. Now, these results have been replicated within the KALM-2 trial.
This trial lasted for 12 weeks with an added 52-week extension phase. It followed 473 dialysis patients who experienced severe itching resulting from kidney disease. A large portion of patients experienced symptom reduction throughout the trial.
Now, Cara Therapeutics sees the ability to fulfill an unmet market need. The company’s next step is to pursue a New Drug Application in the United States.