Kadmon Announces Publication Of Clinical Data Showing KD025 Improved Clinical Scores In Psoriasis Patients

NEW YORK--(BUSINESS WIRE)--Kadmon Holdings, Inc. (NYSE:KDMN) (“Kadmon” or the “Company”) today announced the publication of clinical data from its completed Phase 2 open-label clinical trial of KD025, its oral Rho-associated coiled-coil kinase 2 (“ROCK2”) inhibitor, in patients with moderate to severe psoriasis. In the study, KD025 treatment improved clinical scores and skin pathology in psoriasis patients via concurrent modulation of the pro- and anti-inflammatory immune cell response. The results were published this week in the Cutting Edge section of the Journal of Immunology.

“We have demonstrated the molecular mechanism of action by which ROCK2 inhibition with KD025 modulates the immune system to treat psoriasis, correlating with improvements in patients’ clinical scores and symptoms”

Preclinical and clinical studies by Kadmon researchers have previously demonstrated the importance of the ROCK2 signaling pathway in autoimmune disease settings. To further explore the therapeutic potential of ROCK2 inhibition, Kadmon conducted a 12-week, open-label, Phase 2 study of KD025 in 38 patients with moderate to severe psoriasis. The results demonstrated that KD025 affected the cellular mechanisms associated with psoriasis progression, as measured in both peripheral blood and the skin, leading to improvements in clinical scores of patients at 12 weeks. Specifically, KD025 significantly reduced peripheral blood levels of IL-17 and IL-23, two pro-inflammatory cytokines, and showed a correlation between changes in IL-17 levels and patients’ clinical scores. In addition, researchers observed a concurrent up-regulation of the immunosuppressive cytokine IL-10 and a significant increase in the percentage of Foxp3+ CD4 T cells in blood, which diminish immuno-inflammatory response. Together, these findings demonstrated the potential of selective ROCK2 inhibition to modulate pro- and anti-inflammatory immune cell responses to treat psoriasis.

“We have demonstrated the molecular mechanism of action by which ROCK2 inhibition with KD025 modulates the immune system to treat psoriasis, correlating with improvements in patients’ clinical scores and symptoms,” said Alexandra Zanin-Zhorov, PhD, Vice President, Head of Immunology at Kadmon and corresponding author of the manuscript. “These results are consistent with our previously published preclinical animal models and cell-based in vitro assays and provide further evidence of the importance of ROCK2 signaling in autoimmune diseases like psoriasis.”

“We have demonstrated the crucial role of the ROCK2 signaling pathway in rebalancing immune response in patients, further validating the therapeutic potential of KD025 in autoimmune disease,” said Harlan W. Waksal, M.D., President and CEO at Kadmon. “We hope to confirm these findings in our ongoing placebo-controlled Phase 2 study of KD025 in psoriasis, which will be carried out for a longer time period in a larger patient population.”

The manuscript, titled “Selective Oral ROCK2 Inhibitor Reduces Clinical Scores in Patients with Psoriasis Vulgaris and Normalizes Skin Pathology via Concurrent Regulation of IL-17 and IL-10,” is available on the Journal of Immunology website here.

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.