Cara Therapeutics Announces Outcome of Part A of KOURAGE-1 Study Evaluating Oral Difelikefalin in Notalgia Paresthetica

Rhea-AI Summary

Cara Therapeutics announced disappointing results from Part A of their KOURAGE-1 study, evaluating oral difelikefalin for notalgia paresthetica (NP). The drug did not show meaningful clinical benefit over placebo at any dose, leading the company to discontinue the clinical program in NP. The Phase 2/3 trial involved 214 patients, and despite the drug's safety profile being consistent with prior trials, it did not achieve the primary endpoint of a ≥4-point improvement in the Itch-Numeric Rating Scale. Cara Therapeutics will now explore strategic alternatives to maximize shareholder value.

Positive

• The safety profile of oral difelikefalin was consistent with prior trials, indicating no new safety concerns.
• The company has $70 million in cash, cash equivalents, and marketable securities as of March 31, 2024, providing a financial cushion for exploring new opportunities.

Negative

• Oral difelikefalin did not show a meaningful clinical benefit over placebo in the KOURAGE-1 Part A study.
• Cara Therapeutics will discontinue their clinical program in NP, resulting in a potential loss of investment in this area.
• The decision to wind down the Phase 2/3 clinical program in NP may signal a significant setback in the company's development pipeline.

Medical Research Analyst

The outcome of the KOURAGE-1 study conveys a significant setback for Cara Therapeutics, particularly given the high expectations surrounding oral difelikefalin for treating notalgia paresthetica (NP). Despite strong proof-of-concept results initially, failing to demonstrate a meaningful clinical benefit in a larger, controlled study indicates that the drug may not be a viable treatment option for NP. This is a major pivot point for the company, as they will need to redirect resources and possibly consider alternative therapies or entirely different indications moving forward. This decision also underscores the inherent risks associated with drug development, where promising early results do not always translate into successful late-stage outcomes. Investors should consider this outcome as a critical juncture in Cara Therapeutics' strategic plans.

Financial Analyst

The discontinuation of the clinical program for oral difelikefalin in NP will have immediate financial implications for Cara Therapeutics. With approximately $70 million in cash and equivalents as of March 31, 2024, the company has some runway to explore strategic alternatives. However, the market reaction could be negative due to the cessation of a highly anticipated program. This could lead to short-term stock volatility. On the flip side, winding down an unsuccessful program can free up resources and reduce ongoing expenses, which might be a prudent move financially. From a valuation perspective, the company's ability to pivot and successfully capitalize on other pipeline candidates or strategic alternatives will be important for long-term growth and shareholder value.

Market Research Analyst

The news implies significant challenges for Cara Therapeutics in meeting the unmet needs of patients with pruritus, specifically for NP. The company faces a strategic inflection point, requiring a reassessment of its market position and potential new therapeutic areas. The failure of oral difelikefalin in a critical study may also affect the company's competitive edge in the pruritus market. Nevertheless, the company’s pivot to explore strategic alternatives could mean partnerships, mergers, or acquisitions that might bring new opportunities or products that can drive future growth. Investors should pay attention to upcoming announcements regarding these strategic moves, as they will be pivotal in shaping the company’s market trajectory.

– Oral difelikefalin did not demonstrate meaningful clinical benefit compared to placebo –

– Company will discontinue clinical program in NP and explore strategic alternatives –

STAMFORD, Conn., June 12, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the outcome from the dose-finding Part A of the KOURAGE-1 study evaluating the efficacy and safety of oral difelikefalin for moderate-to-severe pruritus in adult patients with notalgia paresthetica (NP). Oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo, resulting in the Company’s decision to discontinue the clinical program in NP.

“Given our strong proof-of-concept results in NP and the significant unmet need in this sensory neuropathy, we are disappointed that oral difelikefalin did not demonstrate a meaningful improvement in pruritus compared to placebo in the KOURAGE-1 Part A study,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “We are grateful for the patients and investigators who participated in this study. We will be winding down the Phase 2/3 clinical program in NP and exploring strategic alternatives focused on maximizing shareholder value.”

KOURAGE-1 Part A was a multicenter, randomized, double-blind, placebo-controlled study designed to inform the dose and sample size for the pivotal portions of the Phase 2/3 clinical program. In Part A, 214 patients were randomized to one of four arms: oral difelikefalin 2 mg twice a day (BID), 1 mg BID, 0.25 mg BID or placebo BID for 8 weeks. The primary endpoint was the proportion of patients achieving a ≥4-point improvement from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 8.

Oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo. The drug was generally well tolerated with a safety profile similar to prior trials.

As of March 31, 2024, the Company had approximately $70 million in cash, cash equivalents, and marketable securities.

About Cara Therapeutics

Cara Therapeutics is a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company developed an IV formulation of difelikefalin, which is approved in the United States, EU, and multiple other countries for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide. For more information, visit www.CaraTherapeutics.com and follow the company on X (Twitter), LinkedIn and Instagram.

Forward-looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the winding down of the Company’s Phase 2/3 clinical program in NP, the exploration of strategic alternatives and other statements that are not historical facts. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ending December 31, 2023 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2024. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

MEDIA CONTACT:
Annie Spinetta
6 Degrees
973-768-2170
aspinetta@6degreespr.com

INVESTOR CONTACT:
Iris Francesconi, Ph.D.
Cara Therapeutics
203-406-3700
investor@caratherapeutics.com

FAQ

What was the outcome of the KOURAGE-1 Part A study conducted by Cara Therapeutics?

The KOURAGE-1 Part A study found that oral difelikefalin did not demonstrate meaningful clinical benefit over placebo in treating notalgia paresthetica.

When was the outcome of the KOURAGE-1 Part A study announced?

The outcome was announced on June 12, 2024.

What is the stock symbol for Cara Therapeutics?

The stock symbol for Cara Therapeutics is CARA.

What will Cara Therapeutics do after the KOURAGE-1 Part A study results?

Cara Therapeutics will discontinue their clinical program in NP and explore strategic alternatives to maximize shareholder value.

How many patients were involved in the KOURAGE-1 Part A study?

The study involved 214 patients.

What was the primary endpoint of the KOURAGE-1 Part A study?

The primary endpoint was achieving a ≥4-point improvement from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale at Week 8.

What was the financial status of Cara Therapeutics as of March 31, 2024?

Cara Therapeutics had approximately $70 million in cash, cash equivalents, and marketable securities.