STAMFORD, Conn. - Cara Therapeutics, Inc. (NASDAQ:CARA), a biopharmaceutical company focused on pruritus treatments, has announced the discontinuation of its clinical program for notalgia paresthetica (NP), a sensory neuropathy, after its oral medication difelikefalin failed to show significant effectiveness in a key study.
The company revealed the results from the dose-finding Part A of the KOURAGE-1 study, which did not meet the primary endpoint of a meaningful improvement in itch severity compared to placebo. In the study, 214 patients were randomized to receive either difelikefalin at varying doses or a placebo twice daily for 8 weeks.
The primary measure of success was a reduction in itch severity as recorded on the Itch-Numeric Rating Scale (I-NRS) by the trial's conclusion. Unfortunately, none of the doses of difelikefalin showed a clinical benefit over placebo.
Despite the setback, Cara Therapeutics noted that the drug was generally well tolerated, with a safety profile consistent with previous trials. Christopher Posner, President and CEO of Cara Therapeutics, expressed disappointment in the results but gratitude towards the patients and investigators involved in the study. The company will now focus on strategic alternatives to maximize shareholder value.
Cara Therapeutics has been recognized for developing an intravenous (IV) formulation of difelikefalin, which has been approved in the United States, the EU, and other countries for the treatment of moderate-to-severe pruritus in adult hemodialysis patients with advanced chronic kidney disease. This IV formulation is currently out-licensed globally.
As of March 31, 2024, the company reported having approximately $70 million in cash, cash equivalents, and marketable securities. With the clinical program for NP now winding down, Cara Therapeutics is exploring strategic options moving forward.
The company's announcement is based on a press release statement and is a reflection of the current status of its clinical program for NP. The company’s future plans will be informed by the outcome of its strategic review process.
InvestingPro Insights
Investors following Cara Therapeutics (NASDAQ:CARA) may be weighing the implications of the recent discontinuation of its notalgia paresthetica clinical program. In light of this development, several InvestingPro Tips and real-time data metrics could provide additional context for evaluating the company’s financial health and future prospects.
InvestingPro Tips highlight that Cara Therapeutics holds more cash than debt on its balance sheet, which may offer some financial flexibility as the company reassesses its strategy. Moreover, the company's liquid assets exceed its short-term obligations, suggesting a degree of near-term financial stability.
Still, analysts are not optimistic about the company's profitability in the near term, noting that Cara is quickly burning through cash, has weak gross profit margins, and is not expected to be profitable this year. In fact, analysts anticipate a sales decline in the current year, which could further impact the company's financials.
On the data front, Cara's market capitalization stands at $37.23 million, reflecting investor valuation of the company. The company's revenue has seen a significant decline of nearly 60.83% in the last twelve months as of Q1 2024, and its price has fallen by 80.5% over the last year. The company's gross profit margin is deeply negative at -546.42%, indicating substantial challenges in its operational efficiency and profitability.
For investors seeking a deeper dive into these metrics and additional insights, there are more InvestingPro Tips available at https://www.investing.com/pro/CARA. These could help in forming a comprehensive view of Cara Therapeutics' financial and operational status. Moreover, users can apply the coupon code PRONEWS24 to receive an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking further valuable analysis and data to aid in investment decisions.
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