Kadmon Initiates Placebo-Controlled Phase 2 Clinical Trial Evaluating KD025 in Psoriasis
September 21 2016 - 04:47PM
Business Wire
Kadmon Holdings, Inc. (NYSE:KDMN) today announced that the first
patient has been dosed in a double-blind, placebo-controlled Phase
2 clinical trial of KD025, the Company’s oral inhibitor of
Rho-associated coiled-coil kinase 2 (ROCK2), in moderate to severe
chronic plaque psoriasis. The dose-finding study examines KD025
administered at four doses: 200 mg once daily (QD), 200 mg twice
daily (BID), 400 mg QD and 600 mg QD (administered as 400 mg in the
morning and 200 mg in the evening) compared to matching placebo BID
for 16 weeks in approximately 150 patients in the United
States.
The study builds on results from a recently completed open-label
Phase 2 clinical study of KD025 in moderate to severe psoriasis, in
which 85% of patients completing the trial achieved Psoriasis Area
and Severity Index (PASI) score reductions with minimal side
effects. Of note, 71% of patients receiving KD025 200 mg BID
achieved at least a 50% decrease in PASI score (PASI 50), and 42%
of patients receiving KD025 400 mg QD and achieved PASI 50. In
addition, 84% of patients for whom measurements were available
showed reduced levels of pro-inflammatory cytokine IL-17, the key
driver in psoriasis, with minimal effect on the rest of the immune
system, potentially avoiding toxicities and increased
susceptibility to infections associated with currently available
biologic therapies.
“With its demonstrated safety and targeted anti-inflammatory
activity, we believe KD025 potentially offers a new approach to
treating psoriasis, while preserving normal immune function,” said
Harlan W. Waksal, M.D., President and Chief Executive Officer of
Kadmon. “We are optimistic that data from our placebo-controlled
trial will provide further evidence of the potential value of KD025
as a psoriasis therapy.”
In addition to psoriasis, Kadmon is conducting Phase 2 clinical
trials of KD025 in chronic graft-versus-host disease and in
idiopathic pulmonary fibrosis, diseases in which ROCK2 signaling is
up-regulated.
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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prospectus filed pursuant to Rule 424(b) under the Securities Act
of 1933, as amended, with the SEC on July 27, 2016. Investors and
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statements as a result of new information, future events or
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version on businesswire.com: http://www.businesswire.com/news/home/20160921006538/en/
Kadmon Holdings, Inc.Investor RelationsEllen Tremaine,
646-490-2989ellen.tremaine@kadmon.comorMediaMaeve Conneighton,
212-600-1902maeve@argotpartners.com
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