-- Conference Call and Webcast Tomorrow at 8:30
a.m. ET --
Kadmon Holdings, Inc. (NYSE:KDMN) today announced topline
results from an ongoing Phase 2 clinical trial evaluating KD025,
its Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, in
patients with idiopathic pulmonary fibrosis (IPF) who were
previously treated with or offered pirfenidone and/or nintedanib.
KD025 was well tolerated and demonstrated clinical benefit, with a
median decline in forced vital capacity (FVC), a measure of lung
function, of 48 mL at week 24, compared to a median decline of 175
mL in patients treated with best supportive care (BSC), an absolute
difference of 127 mL and a relative difference of 73%.
“KD025 represents a novel mechanism of action in IPF by
inhibiting ROCK, a central regulator of fibrosis that mediates
several pro-fibrotic responses, including stress fiber formation,
myofibroblast activation and pro-fibrotic gene transcription,” said
Kevin F. Gibson, MD, Professor and Medical Director, Dorothy P. and
Richard P. Simmons Center for Interstitial Lung Disease, University
of Pittsburgh Medical Center and lead investigator of the study.
“In this proof-of-concept trial, KD025 has demonstrated clinical
activity at 24 weeks and was well tolerated, with no apparent
safety signals, potentially offering a new option for patients with
IPF.”
In the open-label trial (KD025-207), patients who were
previously treated with or offered pirfenidone and/or nintedanib
were randomized 2:1 to receive KD025 400 mg QD monotherapy or BSC.
The primary endpoints were safety and tolerability of KD025 and
change in FVC from baseline to 24 weeks. Patients have the option
to continue treatment with KD025 beyond 24 weeks.
As of a data cutoff date of February 1, 2018, 20 evaluable
patients have completed 24 weeks of KD025 treatment, and 9
evaluable patients in the BSC arm have completed 24 weeks of
follow-up. Approximately 44% of all patients enrolled in the trial
had received prior treatment with pirfenidone and/or nintedanib.
Following are key results:
- The median decline in FVC at 24 weeks
was 48 mL in the KD025 arm, compared to a median decline of 175 mL
in the BSC arm, a relative difference of 73%.
- The median decline in FVC % predicted
from baseline to week 24 was 1% in KD025 patients, compared to a
median decline of 2% in BSC patients, a relative difference of
50%.
- Treatment with KD025 reduced the
proportion of patients who experienced IPF progression: At 24
weeks, 20% of KD025 patients experienced FVC % predicted decline
≥5%, compared to 44% of BSC patients, a relative difference of
55%.
- KD025 patients experienced less FVC
decline on an annualized basis relative to the year prior to
enrollment: Evaluable patients randomized to KD025 had an
annualized decline in FVC of 126 mL in the year prior to
randomization, compared to an annualized decline of 32 mL at 24
weeks of KD025 treatment.
- KD025 was well tolerated, with no
drug-related serious adverse events. In addition, 90% of patients
who received KD025 for 24 weeks have elected to continue KD025
treatment beyond week 24.
“We are pleased with today’s results, which demonstrate the
activity and tolerability of KD025 in IPF, including in patients
who have received prior therapy with approved agents,” said Harlan
W. Waksal, M.D., President and CEO at Kadmon. “These findings
support the therapeutic potential of ROCK inhibition in IPF and
further validate Kadmon’s ROCK inhibitor platform, which is being
applied across programs in fibrotic diseases as well as
inflammatory diseases.”
Kadmon plans to present the results from this study at the
American Thoracic Society (ATS) International Conference in May
2018.
Conference Call and Webcast
Kadmon will host a conference call and webcast on February 13,
2018, at 8:30 a.m. ET to discuss top-line results from the
KD025-207 study. To access the webcast, please visit the Investors
section of www.kadmon.com, under “Presentations & Events.” A
replay of the webcast will be archived on the Company's website for
30 days.
Dial-in Information:(866) 762-3021Conference ID: 369-4419
About KD025
KD025 is a selective oral inhibitor of ROCK2, a signaling
pathway involved in the pathogenesis of multiple chronic diseases.
Published research by Kadmon and academic institutions has
demonstrated that KD025 regulates fibrotic processes and aberrant
immune responses. Kadmon is conducting Phase 2 clinical trials of
KD025, including in idiopathic pulmonary fibrosis (IPF) and chronic
graft-versus-host disease (cGVHD).
About IPF
IPF is a progressive fibrotic disease of the lungs, with a
median survival of 3 to 5 years from the time of diagnosis. IPF is
thought to be caused by repetitive environmental injury to the
lining of the lung airways and the resulting abnormal wound-healing
responses. IPF patients are in need of new therapies that provide
clinical benefit.
About Kadmon Holdings, Inc.
Kadmon Holdings, Inc. is a fully integrated biopharmaceutical
company developing innovative products for significant unmet
medical needs. We have a product pipeline focused on fibrotic and
inflammatory diseases.
Forward-Looking Statements
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, if any, 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; and/or (xx) our ability to
achieve cost savings and benefits from our efforts to streamline
our operations and to not harm our business with such efforts. 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 Quarterly Report on
Form 10-Q filed pursuant to Section 13 of the Securities Exchange
Act of 1934, as amended, with the SEC on November 9, 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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version on businesswire.com: http://www.businesswire.com/news/home/20180212006192/en/
Kadmon Holdings, Inc.Ellen Tremaine, Investor
Relations646-490-2989ellen.tremaine@kadmon.com
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