NEW YORK--(BUSINESS WIRE)--Kadmon Holdings, Inc. (NYSE:KDMN) (“Kadmon” or the “Company”) today announced the presentation of data from its completed Phase 2 clinical trial of KD025, the Company’s oral Rho-associated coiled-coil kinase 2 (“ROCK2”) inhibitor, in patients with moderate to severe psoriasis, as well as new preclinical data demonstrating the importance of ROCK2 signaling in regulating the pro-inflammatory aspect of immune response. The data will be presented in oral and poster presentations at the American Association of Immunologists (AAI) Annual Meeting, taking place May 12-16, 2017, in Washington, D.C.
“The data from these studies provide further support for ROCK2 inhibition as a therapeutic approach in autoimmune diseases,” said Alexandra Zanin-Zhorov, PhD, Vice President, Head of Immunology at Kadmon and a lead author on the studies. “ROCK2 signaling represents an important target in autoimmunity, as it regulates STAT3 phosphorylation and transcriptional activity in human T cells, both key contributors to autoimmune conditions.”
“The findings from our completed Phase 2 study of KD025 in psoriasis, which were recently published in the Journal of Immunology, together with the new mechanistic preclinical data, underscore the importance of ROCK2 signaling in controlling auto-aggressive immune responses and support the clinical development of KD025 in autoimmune indications,” said Harlan W. Waksal, President and Chief Executive Officer at Kadmon. “We remain enthusiastic about KD025’s therapeutic potential in autoimmunity and we look forward to announcing data from our ongoing Phase 2 trials in chronic graft-versus-host disease and in moderate to severe psoriasis in the second half of this year.”
In the Company’s completed Phase 2 study, ROCK2 inhibition with KD025 improved clinical scores and skin pathology in psoriasis patients via concurrent modulation of the pro- and anti-inflammatory immune cell response.
The new preclinical data describe the mechanism by which ROCK2 mediates activation of STAT3, a key regulator of the inflammatory pathway, and subsequent transcriptional activity during the induction of pro-inflammatory T cells. Specifically, researchers demonstrated that ROCK2 binds to STAT3 and regulates the transcription of specific genes that control pro-inflammatory T helper 17 (Th17) cell and T follicular helper (Tfh) cell function. These findings highlight the importance of ROCK2 signaling in controlling auto-aggressive immune responses.
About Kadmon Holdings, Inc.
Kadmon Holdings, Inc. is a fully integrated biopharmaceutical company focused on developing innovative products for significant unmet medical needs. We have a diversified product pipeline in autoimmune and fibrotic diseases, oncology and genetic diseases.
Safe Harbor Statement
This press release contains forward-looking statements. Such statements may be preceded by the words “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We believe that these factors include, but are not limited to, (i) the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; (ii) our ability to advance product candidates into, and successfully complete, clinical trials; (iii) our reliance on the success of our product candidates; (iv) the timing or likelihood of regulatory filings and approvals; (v) our ability to expand our sales and marketing capabilities; (vi) the commercialization of our product candidates, if approved; (vii) the pricing and reimbursement of our product candidates, if approved; (viii) the implementation of our business model, strategic plans for our business, product candidates and technology; (ix) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (x) our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; (xi) costs associated with defending intellectual property infringement, product liability and other claims; (xii) regulatory developments in the United States, Europe and other jurisdictions; (xiii) estimates of our expenses, future revenues, capital requirements and our needs for additional financing; (xiv) the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; (xv) our ability to maintain and establish collaborations or obtain additional grant funding; (xvi) the rate and degree of market acceptance of our product candidates; (xvii) developments relating to our competitors and our industry, including competing therapies; (xviii) our ability to effectively manage our anticipated growth; (xix) our ability to attract and retain qualified employees and key personnel; (xx) our ability to achieve cost savings and other benefits from our efforts to streamline our operations and to not harm our business with such efforts; and (xxi) the use of proceeds from our recent private placement. More detailed information about Kadmon and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the U.S. Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K filed pursuant to Section 13 of the Securities Exchange Act of 1934, as amended, with the SEC on March 22, 2017. Investors and security holders are urged to read these documents free of charge on the SEC's web site at www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.