Source: Swedish Orphan Biovitrum AB
Swedish Orphan Biovitrum AB (publ) (Sobi) announced its intention to bring a
novel investigational biopharmaceutical drug candidate, SOBI002, into a phase I
trial. The company also shared information regarding phase III data for
Kepivance® recently acquired from Amgen. These updates as well as expectations
for top line data for Kiobrina early next year were provided today at the
company's Capital Markets Event in Stockholm.
SOBI002 is a small biologic molecule based on the Affibody® platform that works
as a potent and selective inhibitor of complement protein C5, a key protein in
human immunological and inflammatory processes and central to a number of
"The advancement of SOBI002 into a phase I clinical trial marks an important
milestone for Sobi", said Geoffrey McDonough, CEO and President at Sobi. "It is
a solid validation of our partnership-oriented biologics innovation model and
could address a wide set of rare disease indications where C5 plays a role."
"We believe that the Affibody technology may offer a differentiated way to treat
complement driven diseases, due to the small size, high solubility and stability
of the molecule", said David Bejker, CEO at Affibody. "Sobi is well positioned
to take advantage of the potentially unique features of SOBI002 as they have an
excellent skill-set to develop and commercialize biologics for rare diseases."
The study will evaluate single and repeated doses of SOBI002 administered
subcutaneously and intravenously in healthy volunteers. Sobi expects to be able
to commence the clinical trial during the first quarter 2014.
Sobi also highlighted data from two phase III clinical trials concerning
Kepivance. The trials demonstrate the potential for Kepivance to reduce the
incidence and duration of severe oral mucositis, a complication of chemotherapy
and radiotherapy regimens for Head and Neck cancers. The company is preparing
to discuss the potential for a supplemental Biologics License Application (sBLA)
filing to support a label expansion for Kepivance with the US Food and Drug
Regarding the Kiobrina phase III study, Sobi explained that the top line data
will initially include the primary endpoint of growth velocity at four weeks as
well as some secondary endpoints from the period of the preterm infants'
hospitalization. The company reiterated its expectation that the top line data
for the study will be available in the first quarter in 2014.
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Sobi is an international specialty healthcare company dedicated to rare
diseases. Our mission is to develop and deliver innovative therapies and
services to improve the lives of patients. The product portfolio is primarily
focused on inflammation and genetic diseases, with three late stage biological
development projects within haemophilia and neonatology. We also market a
portfolio of specialty and rare disease products for partner companies. Sobi is
a pioneer in biotechnology with world-class capabilities in protein biochemistry
and biologics manufacturing. In 2012, Sobi had total revenues of SEK 1.9 billion
(€ 215 M) and about 500 employees. The share (STO: SOBI) is listed on NASDAQ OMX
Stockholm. More information is available at www.sobi.com.
Affibody is a biotech company focused on developing next generation
biopharmaceuticals based on its unique proprietary technology platforms:
Affibody® molecules and Albumod(TM). Affibody is developing a portfolio of
innovative drug projects and, in addition, offers the half-life extension
technology, Albumod(TM), for outlicensing. Affibody has ongoing commercial
relationships with several companies including Algeta, Amylin, Sobi, Daiichi-
Sankyo, Daewoong, GE, and Thermo Fisher. Affibody was founded in 1998 by
researchers from the Royal Institute of Technology and the Karolinska Institute
and is based in Stockholm, Sweden. Major shareholders in the Company include
HealthCap and Investor AB. More information is available at www.affibody.com.
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