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CR845 (Difelikefalin), A Kappa Receptors Agonist In Phase III By CARA Therapeutics

CR845: (difelikefalin), a peripheral opioid agonist currently developed by Cara Therapeutics, an analysis.

CR845 (Difelikefalin), A Kappa Receptors Agonist In Phase III By CARA Therapeutics

Maintaining high standards of Responsible Research and Innovation (RRI) in every communication related to new drug development is of utmost importance, as it helps to maintain public and investors trust in the research enterprise, and supports a platform of debate between industry and medical profession. Here we will analyze the structure of scientific company communications during nearly a decade, related to the peripherally acting kappa receptors agonist CR845 (difelikefalin), currently developed by Cara Therapeutics. Peripheral kappa agonism is a new principle to treat chronic or post-operative pain.
Phase I development of CR845 started in 2008, phase II studies have been completed, and phase II/III is ongoing for two formulations: an intravenous formulation (IV) for postoperative analgesia and uremic pruritus, and an oral formulation for treatment of chronic pain such as in osteoarthritis. Soon (1st half of 2017) new data from phase IIb is expected to become available. It is scheduled that the file of CR845 will be submitted to the authorities for approval in 2018, the key indication for the IV formulation is still unclear.
Although the clinical development phase started in 2008, independent scientific publications in peer reviewed journals to date are absent. The only sources for information and valuation of the company available are some abstracts and posters, written by company employees, and many press releases of CARA Therapeutics. All scientific information related to CR845 after 9 years of development thus are company based, making a thorough evaluation for scientists and clinicians of the value of the principle for patients rather difficult. Moreover, only company based information are the drivers of the valuation of the company on the stock market.
We will present the profile of CR845 based on the information presently available and discuss this in the context of disseminating scientific information in a peer review free environment. So far the company’s track record of quick recruitment in trials and the promising profile communicated supports hope for the targeted indications. Our recommendation for companies developing new treatment principles is, to facilitate actively publications of data in peer reviewed journals as soon as possible, to support independent scientific evaluation of such principles. Press releases should not stay long in the public domain as the sole vehicles for the communication of new scientific facts and the sole base of the valuation of the company and its assets.

Introduction
How to maximize the economic and social benefit, without loss of scientific integrity? A question put forward in the publication ‘BIG SCIENCE (2015): What’s It Worth? From CERN, ESADE Business School and the Aalto University, but remained a question with no answer. Maintaining high standards of ethical and scientific integrity is of utmost importance, as it helps to maintain public trust and investors trust in the research enterprise. The integrity of a scientist should be based on adherence to two core values of science: respect for evidence and evidence-sharing.
We will analyze respect for evidence and evidence-sharing based on what is known about CR845 in the public domain, press releases of CARA and some posters presented by company representatives, based on the context we outline here. It is known, that under the US securities laws (Securities Act of 1933), company are required to publish results, which an average investor would deem important in making investment decisions, as soon as possible. However, there is great freedom in how this public reporting obligation can be shaped, and the case of CR845 will serve as an example, based on which we will make some recommendations.