Kadmon Announces Publication of Clinical Data Showing KD025 Improved Clinical Scores in Psoriasis Patients
April 12 2017 - 9:00AM
Business Wire
-- Findings Published in Cutting Edge section
of the Journal of Immunology --
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.
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.
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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
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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
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(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.
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Kadmon Holdings, Inc.Ellen Tremaine, Investor
Relations646.490.2989ellen.tremaine@kadmon.comorMaeve
Conneighton212.600.1902maeve@argotpartners.com
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