Benzinga - by Vandana Singh, Benzinga Editor.
Cara Therapeutics Inc (NASDAQ: CARA) announced the outcome from the dose-finding Part A of the KIND 1 study evaluating the efficacy and safety of oral difelikefalin as adjunct therapy to topical corticosteroids (TCS) for moderate-to-severe pruritus in adult patients with atopic dermatitis (AD).
Oral difelikefalin as an adjunct to TCS did not demonstrate a meaningful clinical benefit compared to TCS alone, resulting in the company's decision to discontinue its clinical program in pruritus associated with atopic dermatitis.
The company's Korsuva (difelikefalin) injection is the first and only FDA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.
Cara expects to end 2023 with approximately $100 million in cash.
The company's late-stage oral difelikefalin clinical programs for pruritus associated with notalgia paresthetica and advanced chronic kidney disease continue to enroll on track with key data readouts expected in 2H24.
Needham analyst considered the Phase 3 AD program a venture with a high-risk/high-reward potential.
CARA was positioning oral Korsuva as a safer and tolerable oral anti-itch drug that could be used after or in conjunction with topical steroids, but before JAK inhibitors and biologics. An improvement in 4+ points is considered clinically meaningful. CARA provided no clinical data details on the Part A readout.
Among CARA's three late-stage programs, investors perhaps had the least confidence in the success of Phase 3, considering the Phase 2 data. Nevertheless, the analyst does not anticipate significant implications from this assessment for the notalgia paresthetica or chronic kidney disease readouts.
Needham removed AD revenues from the model and lowered the price target to $6 from $22, with a Buy rating.
Price Action: CARA shares are down 48.4% at $0.6344 on the last check Monday.
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Latest Ratings for CARA
| Mar 2022 | JP Morgan | Upgrades | Neutral | Overweight |
| Aug 2021 | HC Wainwright & Co. | Maintains | Buy | |
| Aug 2021 | JP Morgan | Initiates Coverage On | Neutral |
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