DGAP-News: SuppreMol releases positive interim Phase Ib/IIa results on SM101 in Primary Immune Thrombocytopenia (ITP) trials
(firmenpresse) - DGAP-News: SuppreMol GmbH / Key word(s): Study
SuppreMol releases positive interim Phase Ib/IIa results on SM101 in
Primary Immune Thrombocytopenia (ITP) trials
14.02.2012 / 12:50
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Press Release
SuppreMol releases positive interim Phase Ib/IIa results on SM101 in
Primary Immune Thrombocytopenia (ITP) trials
Data confirm excellent safety profile and therapeutic activity
Munich, Germany, 14th February, 2012. SuppreMol GmbH, an autoimmune
diseases specialist, today announced interim results of the Phase Ib/IIa
clinical trial of SM101 to treat Primary Immune Thrombocytopenia (ITP).
SM101 was safe and very well tolerated with encouraging efficacy data.
The Phase Ib section of this randomized, double-blind, placebo-controlled,
dose escalating, multi-centric trial enrolled 36 patients that received up
to 12 mg/kg intravenous doses of SM101 as weekly administrations for 4
weeks. SM101 was safe and well tolerated. These data also verify findings
from the earlier Phase Ia trial in 48 healthy volunteers that did not
report any dose limiting toxicity of SM101. The study showed a dose
dependent platelet increase confirming the first therapeutic activity of
SM101 in humans. In the highest dosage group the increase of platelet level
continued throughout the three month follow up period. No ITP rescue
treatment was necessary in these patients.
'These exciting results provide convincing evidence and reason for
SuppreMol to continue with the further development of SM101 in ITP and
other B cell driven autoimmune diseases', said Prof. Peter Buckel, CEO of
SuppreMol GmbH. 'We are very encouraged by these data that indicate the
efficacy of SM101 in humans, especially the long lasting effect on platelet
increase that confirms its fascinating therapeutic potential. SM101
continues to work after only one treatment cycle, unlike current treatments
for ITP, possibly due to its new mode of action. In particular, SM101 may
require a lower dosage frequency than thrombopoietin receptor agonists.'
SuppreMol intends to report full Phase Ib data at a scientific conference
later in 2012.
About SuppreMol
SuppreMol is a privately held biopharmaceutical company developing novel
therapeutics for the treatment of autoimmune and allergic diseases. The
company is pioneering the development of soluble Fc gamma receptors
(Fc(Rs), which are recombinant autologous therapeutic proteins with a
specific immunoregulatory potential. The company plans to develop Fc(Rs for
the treatment of Primary Immune Thrombocytopenia (ITP), Systemic Lupus
Erythematosus (SLE), Rheumatoid Arthritis (RA) and other autoimmune
conditions. SuppreMol's pipeline comprises two early antibody development
programs utilizing the inhibitory effect of Fc(RIIb suitable for
alternative treatment strategies and indications as well as an anti-IL-3
antibody to treat RA. SuppreMol was founded in 2002 as a spin-off from the
laboratory of Prof. Dr. Robert Huber, Nobel Prize for Chemistry in 1988, at
the Max Planck Institute for Biochemistry in Martinsried, Germany.
Investors in the company include MIG Fonds, BioMedPartners AG, Santo
Holding GmbH and FCP Biotech Holding GmbH along with KfW Mittelstandsbank,
Bayern Kapital GmbH, Max Planck Society, and Z-Cube. The study has been in
part supported by a grant from the Federal German Ministry of Education and
Research (BMBF).
About SM101
SuppreMol's lead candidate SM101 is a recombinant, soluble,
non-glycosylated version of the Fc( receptor IIb. The protein binds to
autoantibody/autoantigen complexes and blocks the activation of Fc
receptors on the surface of immune cells. As a result, the immune response
is down regulated and triggering of the inflammation cascade, typically
seen in autoimmune diseases, is prevented. SM101 has been validated in
relevant animal models and has shown strong efficacy by decreasing
inflammation and immune reactions. At present, SM101 is being developed in
Primary Immune Thrombocytopenia (ITP). For this indication, SM101 has
received orphan drug designation in the US and Europe. In November 2011
SM101 started a Phase IIa, double-blind clinical trial in patients
suffering from Systemic Lupus Erythematosus (SLE). The company believes
SM101 may also have potential in Rheumatoid Arthritis (RA) and other B cell
driven autoimmune diseases.
Contact
SuppreMol GmbH
Prof. Dr. Peter Buckel
Chief Executive Officer
Tel: +49 89 30 90 50 680
E-mail: info(at)suppremol.com
www.suppremol.com
End of Corporate News
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