ZymoGenetics, Inc. (Nasdaq:
ZGEN) today announced preliminary positive results from two Phase 1b
clinical trials in patients with systemic lupus erythematosus (SLE) treated
with atacicept (formerly referred to as TACI-Ig). The results demonstrated
a favorable tolerability profile and indicated biological activity
consistent with the mode of action. ZymoGenetics and its partner, Serono
S.A., plan to present full results of these clinical studies at a medical
meeting later this year.
"These positive results show the potential of atacicept for treating
patients with SLE," said Nicole Onetto, M.D., Senior Vice President and
Chief Medical Officer of ZymoGenetics. "We are very encouraged by the
findings of these studies and the results will be beneficial in designing
future studies in this indication."
The primary objective of these two Phase 1b clinical studies was to
determine the safety and tolerability of atacicept administered
subcutaneously or intravenously to patients with SLE. Secondary objectives
included examination of the relationship between the atacicept dose and
schedule with markers of biologic activity and disease activity. In both
studies, atacicept appeared to be well tolerated across all dose levels and
schedules tested in both studies, and clear biologic response corresponding
to the mechanism of action of atacicept was observed.
Both clinical studies were multi-center, double-blind, randomized,
placebo-controlled, dose-escalating studies. In the subcutaneous
administration study, 49 patients were enrolled and patient cohorts
received single or repeated doses (4 weekly doses) of atacicept or placebo.
In the study with intravenous administration, 24 patients were enrolled and
patient cohorts received single or repeated doses (2 doses 21 days apart)
of atacicept or placebo. All patients were monitored during and for several
weeks after for safety. The predominant adverse event noted was a mild
injection site reaction (redness of skin or pain at the injection site).
ZymoGenetics and Serono are planning to start a Phase 2 study of
atacicept later this year in rheumatoid arthritis patients with an
inadequate response to TNF inhibitors. The companies are also conducting
ongoing Phase 1b clinical trials of atacicept in patients with B-cell
malignancies in several open label dose escalation safety studies.
About Atacicept
ZymoGenetics and Serono are developing atacicept (formerly referred to
as TACI-Ig) for the treatment of autoimmune diseases and B-cell
malignancies. Atacicept is a soluble receptor that binds to BLyS and APRIL,
TNF family cytokines that promote B-cell survival and the production of
autoantibodies that are associated with certain autoimmune diseases such as
systemic lupus erythematosus (SLE). 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 ZymoGenetics
ZymoGenetics creates novel protein drugs with the potential to
significantly help patients fight their diseases. The Company is developing
a diverse pipeline of potential proprietary product candidates that are
moving into and through clinical development. These candidates span a wide
array of clinical opportunities that include bleeding, autoimmune 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 zymogenetics/.
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, 2005. 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.
zymogenetics/