ZymoGenetics and Merck Serono Initiate Phase 2/3 Clinical Trial of Atacicept in Lupus...

Thu Dec 13, 2007 2:00am EST

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ZymoGenetics and Merck Serono Initiate Phase 2/3 Clinical Trial of Atacicept in Lupus Nephritis

     Trial will Evaluate Safety and Efficacy of Atacicept in Lupus
     Nephritis and is Intended to Support Marketing Authorization
NEW YORK--(Business Wire)--ZymoGenetics, Inc. (NASDAQ: ZGEN) and Merck Serono, a division of
Merck KGaA, announced today the initiation of a Phase 2/3 clinical
trial of atacicept in lupus nephritis, a severe form of systemic lupus
erythematosus (SLE). The kidneys are affected in at least 30% of the
estimated 1.5 million people suffering from SLE worldwide. This study
will evaluate the efficacy and safety of atacicept for the treatment
of patients with active lupus nephritis.

   The trial is being conducted under a Special Protocol Assessment
(SPA) agreement with the U.S. Food and Drug Administration (FDA) and
is intended to be used as part of a program to support a worldwide
application for marketing authorization.

   "Lupus nephritis patients need better treatment options to help
them maintain kidney function and avoid kidney failure," said Nicole
Onetto, M.D., Senior Vice President and Chief Medical Officer. "Based
on its mechanism of action and our early clinical data in lupus, we
believe that atacicept has the potential to reduce disease symptoms
and may help patients improve kidney function."

   Anton Hoos, M.D., Merck Serono's Head of Global Development,
added: "This study forms part of our ongoing development program with
atacicept in autoimmune and inflammatory diseases. It underscores
Merck Serono's strong commitment to offering innovative treatment
options to patients and their doctors in indications with unmet
medical needs."

   The one-year (52 week), randomized, double-blind,
placebo-controlled Phase 2/3 clinical trial will enroll approximately
200 patients and will be conducted at approximately 80 sites in North
America, Europe, Latin America, and Asia.

   The objective of the study is to evaluate the efficacy and safety
of atacicept in patients with active lupus nephritis who are also
receiving immunosuppressive therapy with mycophenolate mofetil (MMF)
and corticosteroids. To be eligible to enroll in the trial, patients
must have active lupus nephritis at the time of screening. The primary
endpoint of the trial is the improvement in patients' renal function
from baseline to week 52.

   About Atacicept

   Merck Serono and ZymoGenetics are developing atacicept (formerly
referred to as TACI-Ig) as a potential treatment of autoimmune
diseases, such as systemic lupus erythematosus (SLE), lupus nephritis,
rheumatoid arthritis and multiple sclerosis, as well as B-cell
malignancies. Atacicept, a recombinant fusion protein, contains the
soluble TACI receptor that binds to the cytokines BLyS and APRIL.
These cytokines are members of the tumor necrosis factor family that
promote B-cell survival and autoantibody production associated with
certain autoimmune diseases such as systemic lupus erythematosus.
Current data indicates that levels of BLyS and APRIL are elevated in
patients with rheumatoid arthritis, SLE and B-cell malignancies.
Atacicept has been shown to affect several stages of B-cell
development and may inhibit the survival of cells responsible for
making antibodies.

   About Lupus nephritis

   Lupus nephritis is a complication of systemic lupus erythematosus
and is characterized by inflammation of the kidneys. Patients with
lupus nephritis typically have damage to the glomeruli and progressive
loss of kidney function. In the United States, for example, SLE
affects 1 person in 2,000, with higher rates among women and among
individuals with African, Asian, and Hispanic genetic heritage.
Published studies estimate that clinically significant renal
involvement occurs in at least 30% of those with SLE.

   About ZymoGenetics

   ZymoGenetics creates novel protein drugs with the potential to
significantly help patients fight their diseases. The Company is
developing a diverse pipeline of product candidates that are moving
into and through clinical development. These candidates span a wide
array of clinical opportunities that include bleeding, autoimmune and
viral diseases and cancer. ZymoGenetics intends to commercialize these
product candidates through internal development, collaborations with
partners, and out-licensing of patents from its extensive patent
portfolio. For further information, visit www.zymogenetics.com.

   This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are based on the current intent and
expectations of the management of ZymoGenetics. These statements are
not guarantees of future performance and involve risks and
uncertainties that are difficult to predict. ZymoGenetics' actual
results and the timing and outcome of events may differ materially
from those expressed in or implied by the forward-looking statements
because of risks associated with our unproven discovery strategy,
preclinical and clinical development, regulatory oversight,
intellectual property claims and litigation and other risks detailed
in the company's public filings with the Securities and Exchange
Commission, including the company's Annual Report on Form 10-K for the
year ended December 31, 2006. Except as required by law, ZymoGenetics
undertakes no obligation to update any forward-looking or other
statements in this press release, whether as a result of new
information, future events or otherwise.

ZymoGenetics, Inc.
Investor and Media Relations:
Susan W. Specht, MBA, 206-442-6592
Director, Corporate Communications

Copyright Business Wire 2007
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