Cara Therapeutics Prioritizes Late-Stage Notalgia Paresthetica Program and Extends Cash Runway into 2026
Cara Therapeutics, Inc. announced a strategic shift to focus on the oral difelikefalin Phase 2/3 clinical program in notalgia paresthetica (NP) and reduce operating expenses, extending the cash runway into 2026. The company will discontinue the Phase 3 program in advanced chronic kidney disease (CKD) and implement a workforce reduction of up to 50%. The decision is expected to allow the completion of the NP clinical program and reach key value-inflection milestones. The Phase 2/3 clinical program for NP is progressing ahead of projections, with a data readout expected in Q3 2024. The company also announced the departure of Frédérique Menzaghi, Ph.D., Chief Scientific Officer and SVP of Research & Development, effective February 2, 2024.
Positive
Strategic shift to focus on the NP clinical program to address unmet need
Expected extension of cash runway into 2026
Progress ahead of projections for the Phase 2/3 clinical program for NP
Negative
Discontinuation of the Phase 3 program in advanced CKD
Workforce reduction of up to 50%
Departure of Frédérique Menzaghi, Ph.D., Chief Scientific Officer and SVP of Research & Development
The announcement by Cara Therapeutics to concentrate efforts on the Phase 2/3 clinical program for notalgia paresthetica (NP) represents a strategic pivot towards an area with significant unmet medical need and potential market exclusivity. NP is characterized by chronic pruritus, a symptom for which there are no FDA-approved treatments, indicating a clear pathway for market entry should the trials prove successful. The decision to focus on this program aligns with the industry trend of targeting niche markets with specialized therapies.
From a research perspective, the progression of the KOURAGE trial ahead of projections is a positive indicator of the company's operational efficiency and could signal a higher probability of timely FDA submission. The anticipation of a data readout in Q3 2024 will be crucial, as it will provide insights into the drug's efficacy and safety, which are key determinants of its commercial viability. The estimated addressable market of 650,000 patients in the U.S. presents a noteworthy opportunity for Cara Therapeutics, assuming the therapy's approval and adoption.
The discontinuation of the advanced chronic kidney disease (CKD) program by Cara Therapeutics is a significant operational shift that will likely impact the company's financial projections and resource allocation. The planned workforce reduction of up to 50% is a cost-cutting measure that aims to extend the company's cash runway into 2026. This is a critical move to preserve capital in anticipation of the NP program's completion. However, such reductions can also pose risks to company morale and future productivity.
With Cara ending 2023 with approximately $101 million in cash, the financial runway extension is a strong point for investor consideration, as it suggests that the company will not require additional funding in the near term. This could reduce dilution risk for current shareholders. Nonetheless, the market will be closely monitoring the upcoming data readouts and trial results for their potential to either enhance or detract from shareholder value.
The strategic refocusing on NP by Cara Therapeutics highlights the company's attempt to capitalize on a niche market with a first-in-class therapy for a disorder lacking FDA-approved treatments. This move is in line with pharmaceutical market trends where companies target specific, underserved patient populations to achieve market penetration and premium pricing. The projected addressable market size and the lack of competition are favorable factors that could facilitate rapid market adoption and peak sales achievement upon successful completion of the clinical program and subsequent product launch.
Analyzing the potential market dynamics, Cara's oral difelikefalin would likely benefit from orphan drug status incentives, including extended market exclusivity, which could enhance its market position. The company's ability to meet the expected key value-inflection milestones will be instrumental in determining its future market share and revenue potential within the NP treatment landscape.
01/22/2024 - 07:00 AM
– Focus on Phase 2/3 program in notalgia paresthetica (NP), a neuropathic disorder with significant unmet need –
– Phase 3 program in advanced chronic kidney disease (CKD) to be discontinued –
– Planned workforce reduction of up to 50% –
– Cara ended 2023 with approximately $101 million in cash; runway extended into 2026 –
– Company to host conference call and webcast today at 8:30 a.m. EST –
STAMFORD, Conn., Jan. 22, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA) today announced it will focus its resources on the oral difelikefalin Phase 2/3 clinical program in notalgia paresthetica (NP) and significantly reduce its operating expenses. These measures will extend the Company’s cash runway into 2026, enabling the expected completion of the NP clinical program.
“We are sharpening our clinical focus on the rapidly progressing Phase 2/3 study in NP, which we believe is the therapeutic indication with the greatest commercial potential for oral difelikefalin,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “Following careful consideration, we have decided to discontinue our work in advanced chronic kidney disease (CKD). I would like to thank the patients and investigators who have participated in our advanced CKD clinical program, as well as our employees for their commitment to transforming the lives of CKD patients suffering from pruritus.”
Mr. Posner continued, “Unfortunately, as a result of the difficult decision to restructure the Company, many of our talented team members will depart the organization. I am deeply grateful for their dedicated service and support of our mission. We expect the changes we are making to extend our cash runway into 2026, allowing us to reach all expected key value-inflection milestones in the NP clinical program.”
Focus on Late-Stage Notalgia Paresthetica Clinical Program
Enrollment in the Phase 2/3 clinical program evaluating oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with NP, known as KOURAGE, is progressing ahead of the Company’s projections. A data readout from the dose-finding portion of the program is expected in the third quarter of 2024. Final topline results from the first pivotal study are expected by the end of 2025 with the second pivotal study results in early 2026.
NP is a common but under-recognized neuropathic disorder characterized by chronic pruritus affecting the upper back. NP is challenging to manage, as there are currently no FDA-approved therapies to treat the disorder. Oral difelikefalin is the only therapy in development for NP. NP represents a sizable, underserved patient population with an estimated addressable market of 650,000 patients in the U.S. who are under the care of a healthcare provider, not accounting for those who are undiagnosed.
Leadership Update
Frédérique Menzaghi, Ph.D., Chief Scientific Officer and SVP of Research & Development, will depart the Company, effective February 2, 2024.
“On behalf of the entire Cara team, I would like to express our sincere gratitude to Fred for all her contributions and dedication to the organization over the past 20 years. As one of Cara’s founders, her scientific leadership helped shape the trajectory of the company from start-up to a publicly traded company,” said Mr. Posner.
Conference Call & Webcast
Cara will host a conference call and webcast today at 8:30 a.m. EST to discuss the corporate update.
To participate in the conference call, please register here . Registrants will receive the dial-in numbers and a unique PIN.
A live audio webcast and archived replay of the call will be available under “Events & Presentations” in the Investors section of the Company’s website at www.CaraTherapeutics.com .
About the KOURAGE Phase 2/3 Clinical Program in Notalgia Paresthetica
KOURAGE is a Phase 2/3 clinical program evaluating oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica (NP). The program is comprised of two studies – KOURAGE 1 and KOURAGE 2 – which are double-blind, placebo-controlled, 8-week studies with patients allowed to roll-over into open-label 52-week extensions.
KOURAGE 1 is composed of two parts. The dose-finding portion of KOURAGE 1 (Part A) is expected to include 200 patients who will be randomized equally to four arms (0.25 mg BID, 1.0 mg BID, 2.0 mg BID, placebo BID). The Company expects a data readout from the dose-finding portion of KOURAGE 1 in the third quarter of 2024. This readout will provide key information, specifically the dose and sample size to initiate the Phase 3 portions of the program – Part B of KOURAGE 1 and the second pivotal study KOURAGE 2.
Part B and KOURAGE 2 will be double-blind, placebo-controlled, 8-week studies with patients randomized 1:1 to either difelikefalin or matching placebo. The primary endpoint will be the proportion of patients with a ≥4-point improvement at Week 8 from baseline in the worst itch numeric rating scale. The Company expects final topline results from the first pivotal study by the end of 2025 with the second study by early 2026.
About Cara Therapeutics
Cara Therapeutics is a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. 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. The Company is developing an oral formulation of difelikefalin, with an ongoing Phase 2/3 clinical program for patients with notalgia paresthetica, a neuropathic disorder characterized by chronic pruritus of the upper back for which there are no FDA-approved therapies. 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 Company’s strategic plans to focus its resources on the development of oral difelikefalin for the treatment of pruritus associated with notalgia paresthetica and to discontinue the development of oral difelikefalin in advanced chronic kidney disease, the timing of enrollment and data readouts from the Company’s planned and ongoing clinical trials, and the Company’s cash runway. 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 and uncertainties include the risks inherent in the launch of new products, including that our commercial partners may not perform as expected, risks inherent in the clinical and regulatory development of pharmaceutical products, and the risks 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, 2022 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2023. 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.
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INVESTOR CONTACT: investor@caratherapeutics.com
What is Cara Therapeutics, Inc. focusing on with its strategic shift?
Cara Therapeutics, Inc. is focusing on the oral difelikefalin Phase 2/3 clinical program in notalgia paresthetica (NP) and reducing operating expenses to extend the cash runway into 2026.
What program is Cara Therapeutics, Inc. discontinuing?
Cara Therapeutics, Inc. is discontinuing the Phase 3 program in advanced chronic kidney disease (CKD).
When is a data readout expected for the Phase 2/3 clinical program for NP?
A data readout is expected in the third quarter of 2024.
Who is departing from Cara Therapeutics, Inc. as announced in the PR?
Frédérique Menzaghi, Ph.D., Chief Scientific Officer and SVP of Research & Development, will depart the Company, effective February 2, 2024.
