Kadmon Initiates Phase 2 Clinical Trial Evaluating KD025 in Chronic Graft-Versus Host Disease
NEW YORK--(BUSINESS WIRE)--
Kadmon Holdings, Inc. (NYSE:KDMN) today announced that the first patient
has been dosed in a Phase 2 clinical trial of KD025, the Company’s
rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, for the treatment
of chronic graft-versus-host disease (cGVHD). The randomized,
open-label, 24-week study examines the safety, tolerability and activity
of KD025 dosed at 200 mg once daily (QD), 200 mg twice daily (BID) or
400 mg QD in 48 cGVHD patients in the United States.
cGVHD is a common and often fatal complication following allogeneic stem
cell transplantation in which donor immune cells attack the recipient’s
body, leading to fibrosis in multiple organs. Preclinical research
conducted by Kadmon in collaboration with Bruce Blazar, MD, of the
University of Minnesota and recently published in the journal Blood demonstrated
that ROCK2 inhibition with KD025 down-regulated clinical symptoms in
multiple murine models of cGVHD. KD025 treatment also down-regulated the
pro-inflammatory signaling pathways involved in cGVHD pathogenesis and
simultaneously up-regulated regulatory cell function in these murine
models, reducing overall cGVHD progression while preserving normal
“Kadmon’s preclinical research has demonstrated the potential of ROCK2
inhibition to treat a number of autoimmune and fibrotic diseases,
including cGVHD, a serious condition with limited treatment options,”
said Harlan W. Waksal, M.D., President and Chief Executive Officer of
Kadmon. “In this Phase 2 study, we hope to further assess the ability of
KD025, our lead ROCK2 inhibitor, to ameliorate the cGVHD process.”
In addition to cGVHD, Kadmon is investigating the potential of KD025 to
treat other autoimmune and fibrotic diseases. The company is conducting
an ongoing Phase 2 clinical study of KD025 for the treatment of
idiopathic pulmonary fibrosis, with a planned Phase 2 study in moderate
to severe psoriasis.
About Kadmon Holdings, Inc.
Kadmon Holdings, Inc., is a fully integrated biopharmaceutical company
engaged in the discovery, development and commercialization of small
molecules and biologics to address disease areas of significant unmet
medical need. Kadmon is developing product candidates within 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; and (xix) our
ability to attract and retain qualified employees and key personnel.
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 prospectus filed pursuant to Rule 424(b)
under the Securities Act of 1933, as amended, with the SEC on July 27,
2016. 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
View source version on businesswire.com: http://www.businesswire.com/news/home/20160921006508/en/
Kadmon Holdings, Inc.
Ellen Tremaine, 646.490.2989
Source: Kadmon Holdings, Inc.