Cara Therapeutics (NASDAQ:CARA) has announced positive topline data from its second phase trial of Oral KORSUVA in treating chronic kidney patients with pruritus. Cara develops and commercializes new drugs designed to improve pruritus through selective targeting of peripheral kappa opioid receptors.
Oral KORSUVA tablets show positive results in the treatment of CKD
Derek Chalmers, the CEO and President of Cara Therapeutics, indicated that pruritus in chronic kidney disease is still a significant unmet medical need for several patients with CDK in the US. He added that they were pleased that the second phase trial had managed to identify a suitable tablet strength of Oral KORSUVA for the next phase. The next phase, which is the Phase III registration program, will be initiated in 2020.
The positive results indicate that Oral KORSUVA could be the first drug therapy to receive approval in the US in the treatment of chronic kidney disease patients with moderate-to-severe pruritus. This is according to Gil Yosipovitch MD Dr. Philip Frost Dermatology and Cutaneous surgery department and the Director of Miami Itch Centre. He added that there is a significant unmet medical need for effective long term therapy in the treatment of Intractable Pruritus. Gill affirmed that the results of the study have shown that Oral KORSUVA has great potential and promise for chronic kidney disease patients.
Second Phase trial achieved primary efficacy endpoint
The second phase trial was a randomized, multicentre, double-blind placebo-controlled study for 12 weeks. The study was designed to assess the safety and efficacy of Oral KORSUVA in three dose levels. The levels were 0.25 mg, 0.5 mg, and 1 mg administered daily versus placebo in around 240 patients with stage II-V chronic Kidney disease suffering from pruritus.
The primary efficacy endpoint of the study was to change from the reference line in the weekly mean of the Worst Itching Intensity Numeric Rating Scale score at 12 weeks of treatment with Oral KORSUVA relative to placebo. The study achieved the primary endpoint with patients treated with 1 mg of Oral KORSUVA, showing a significant reduction in the weekly WI-NRS scores relative to placebo groups after 12 weeks.