Statements contained in this presentation 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 expected timing of the initiation, enrollment and data readouts from the Company's planned and ongoing clinical trials, the potential results of ongoing clinical trials, timing of future regulatory and development milestones for the Company's product candidates, the potential for the Company's product candidates to be alternatives in the therapeutic areas investigated, the Company's expected cash reach, and the potential impact of COVID-19 on the Company's commercial launch, clinical development and regulatory timelines and plans. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. 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, 2021 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this presentation 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.
Today's Speakers
Christopher A. Posner
Dr. Joana Goncalves, M.D.
President & CEO
Chief Medical Officer
Dr. Brian Kim, MD, MTR
Dr. Jonathan Silverberg, MD, PHD, MPH
Sol and Clara Kest Professor | Vice Chair of Research | Site Chair, Mount Sinai West and Morningside | Director, Mark Lebwohl Center for Neuroinflammation and Sensation | The Kimberly and Eric J. Waldman Department of Dermatology | Precision Immunology Institute | Friedman Brain
Director, Clinical Research | Director,
Patch Testing | Associate Professor, Department of Dermatology | The George Washington University School of Medicine and Health Sciences, Washington, DC
3
Agenda
01
Introductory Remarks
Christopher Posner, CEO, President and Director, Cara Therapeutics
02
Review of Oral Difelikefalin Phase 3 Clinical Programs in
Patients with Advanced CKD and AD-associated Pruritus
Dr. Joana Goncalves, MD, CMO, Cara Therapeutics
03
04
05
Oral difelikefalin is an investigational agent that has not been approved by the FDA.
4 The efficacy and safety of oral difelikefalin has not been established.
Difelikefalin Potential Mechanism of Action in Atopic Dermatitis
Dr. Brian Kim, MD, MTR
Heterogeneity and Novel Phenotypes of Atopic Dermatitis
Dr. Jonathan Silverberg, MD, PHD, MPH
Live Q&A Session
Introductory Remarks
CHRISTOPHER POSNER
CEO, PRESIDENT AND DIRECTOR, CARA THERAPEUTICS
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CARA Therapeutics Inc. published this content on 11 March 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 11 March 2022 23:03:08 UTC.
Cara Therapeutics, Inc. is a development-stage biopharmaceutical company. The Company is focused on treatment paradigm to improve the lives of patients suffering from chronic pruritus. It is developing an oral formulation of difelikefalin, a selective, predominantly peripherally acting, non-scheduled Kappa opioid receptor agonist, for the treatment of chronic neuropathic pruritus associated with Notalgia Paresthetica (NP), a common, underdiagnosed neuropathy affecting the upper back. It is conducting Phase II/III Clinical Program in NP. The program is comprised of two studies - KOURAGE 1 and KOURAGE 2, which are double-blind, placebo-controlled, eight-week studies with patients allowed to roll-over into open-label 52-week extensions. It has developed an IV formulation of difelikefalin, 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.