Cara Therapeutics said Oral KORSUVA met its primary endpoint in the Phase 2 trial, but didn’t meet its secondary endpoints.
Cara Therapeutics (NASDAQ:CARA) released topline results from its Phase 2 trial evaluating Oral KORSUVA in chronic kidney disease (CKD) patients with pruritus on Tuesday (December 3), sending its share prices — surprisingly — deep into the red.
In the press release, the company said that CKD-related pruritus — which is itchy skin or a sensation that prompts the desire to scratch — continues to be an area that is highly unmet for roughly a third of patients diagnosed with CKD.
As such, Cara Therapeutics indicated the Phase 2 trial met its primary endpoint, which was a reduction in the mean worst itching intensity numeric rating scale (WI-NRS) score versus a placebo at the 12 week mark of treatment. However, the company reported the treatment didn’t meet its secondary endpoints.
Following the announcement, shares of Cara Therapeutics were down almost 18 percent over the course of Tuesday’s trading session to close at US$16.94. The company’s share price was down over 34.5 percent from its Monday (December 2) close of US$25.88.
“We are pleased that this Phase 2 study has successfully identified an appropriate tablet strength of Oral KORSUVA to carry forward into a pivotal Phase 3 registration program which we expect to initiate next year,” Derek Chalmers, president and CEO of Cara Therapeutics, said in the release.
In a conference call with investors on Tuesday, the company said that a “positive dose-related trend” was seen for all of the secondary endpoints. Oral KORSUVA was also well tolerated with the safety profile consistent with previous studies.
The Phase 2 trial took place over the course of 12 weeks and enrolled roughly 240 CKD patients with pruritus. The trial evaluated the safety and efficacy of three different dosage levels of Oral KORSUVA versus a placebo.
Subjects were equally randomized to receive 0.25 milligrams (mg), 0.5 mg or 1 mg of the treatment or a placebo once a day throughout the course of the trial. In the week before randomization, the company said patients had to have a baseline score greater than or equal to five out of a scale of 10 defined by the WI-NRS score.
Following randomization, patients reported on a daily basis their WI-NRS intensity until the end of the trial.
While the company met its primary endpoints, the secondary endpoints – which included the number of patients taking the 1 mg dose posting a 3 point or more improvement from baseline in the weekly mean of the daily WIR-NRS score — were not met by week 12. For Oral KORSUVA, that number was a 72 percent increase versus 58 percent for the placebo, indicating the treatment didn’t have a statistical significance.
The other secondary endpoint — which evaluated patients on the 1 mg dose showing improvements versus the placebo in itch-related quality of life — did have some improvements, although it, too, was not significant enough.
In the end, a 1 mg dosage was found to be the appropriate amount to be used in a Phase 3 study, which the company anticipates initiating sometime in 2020.
“There is an unmet medical need for an effective long-term therapy for treating intractable pruritus and the results from this trial suggest Oral KORSUVA holds great promise for CKD patients,” Gil Yosipovitch, professor at the Dr. Phillip Frost department of dermatology and Cutaneous Surgery and director of the Miami Itch Center, said in the release.
With plans for a Phase 3 trial sometime in 2020, this brings the company’s Oral KORSUVA treatment one step closer to being US Food and Drug Administration (FDA)-approved and giving patients with CKD-associated pruritus relief. As it currently stands, the company said there are no approved therapies to treat moderate-to-severe pruritus in CKD patients.
Despite a share price drop, the company remains a “strong buy” based off three analyst ratings on TipRanks — each of whom reiterated their “buy” positions on Tuesday. Cara Therapeutics currently has an average price target of US$32.67 — which is a 93 percent increase from its current price — a high of US$35 and a low of US$30.
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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.