SuppreMol GmbH / SuppreMol's SM101 shows a sustained clinical activity and a favorable safety profile in Primary Immune Thrombocytopenia (ITP) patients . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.
Munich, Germany, December 10, 2012: SuppreMol GmbH, a biopharmaceutical company focused on the development of novel therapeutics for the treatment of autoimmune diseases, today announced the presentation of interim results from an ongoing Phase Ib/IIa clinical trial in ITP patients. In the dose escalation part of the study, patients were treated at dose levels between 0.3 and 12 mg/kg and received 5 injections of SM101 during the 8 week treatment cycle. Three out of four patients treated with 12 mg/kg of SM101 showed a clinically important and sustained increase in platelet count after a single cycle of treatment with SM101. At dose levels of up to 12 mg/kg SM101, no safety concerns have been identified.
The data were reported in a poster presentation (abstract # 3388) today at the 54th American Society of Hematology (ASH) Annual Meeting in Atlanta, GA.
"The interim data of SM101 in patients suffering from chronic ITP are very encouraging", comments Dr. Tatyana Semenovna Konstantinova of GUZ Sverdlovskaya Regional Clinical Hospital #1, Yekaterinburg, Russia, a Principal Investigator for the ongoing Phase Ib/IIa study. "The combination of sustained platelet response after a single cycle of SM101 and the favorable safety profile certainly warrants further development of this exciting therapeutic approach."
"Current therapies of chronic ITP all have important limitations", comments Dr. David Kuter from Massachusetts General Hospital, Harvard Medical School, an expert in the treatment of ITP. "SM101 has a novel mechanism of action that is designed to selectively modulate the immune response. Early clinical data presented at ASH suggest that it has the potential to provide a prolonged increase in platelet counts in patients with ITP."
SuppreMol has an ongoing dose-escalation trial in ITP in Europe and intends to initiate a randomized Phase II clinical trial in ITP in the US and Europe in 2013.
The poster presented at ASH can be found at http://www.suppremol.com/tl_files/pdf/Poster/SuppreMol-ASH2012-poster_SM101.pdf (http://www.suppremol.com/tl_files/pdf/Poster/SuppreMol-ASH2012-poster_SM101.pdf)
About SM101
SuppreMol's lead candidate, SM101, is a recombinant, soluble, non-glycosylated version of the Fc-gamma-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 as is the associated inflammation cascade, typically observed in autoimmune diseases. The efficacy of SM101, including a reduction of inflammation and immune parameters, has been demonstrated in relevant animal models. Currently, SM101 is being evaluated in a Phase II trial in ITP. SM101 has received orphan drug designation in the US and Europe for ITP. In addition, SM101 is being studied in a Phase II, double-blind clinical trial in patients with Systemic Lupus Erythematosus (SLE). SM101 also has a potential in a number of other B cell driven autoimmune diseases, including Rheumatoid Arthritis (RA).
About Primary Immune Thrombocytopenia
ITP is a severe autoimmune disease mediated by antibodies of the patient's immune system targeting and destroying the patient's platelets. An adequate number of platelets is essential for the control of bleeding. The immune response to platelets in ITP can result in extremely low platelet counts, which can result in severe, sometimes fatal, bleeding. ITP occurs in about 10 of 100,000 people and is more prevalent in women compared to men. Current treatment includes long-term treatment with corticosteroids, IVIg, splenectomy, other chronic immunosuppressive therapies (including B cell depleting antibodies) and thrombopoetin (TPO) receptor agonists.
About SuppreMol
SuppreMol GmbH 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 (FcgRs), which are recombinant autologous therapeutic proteins with a specific immunoregulatory potential. The company is developing FcgRs in two ongoing Phase II studies for the treatment of ITP, Systemic Lupus Erythematosus (SLE) and potentially for Rheumatoid Arthritis (RA) and other autoimmune conditions. SuppreMol's pipeline includes two antibody development programs utilizing the inhibitory effect of FcgRIIB suitable for alternative treatment strategies and indications as well as an anti-IL-3 antibody to treat RA.
Contact
SuppreMol GmbH
Prof. Dr. Peter Buckel
Chief Executive Officer
Tel: +49 89 30 90 50 680
E-mail: info@suppremol.com (mailto:info@suppremol.com)
www.suppremol.com (http://www.suppremol.com/)
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Source: SuppreMol GmbH via Thomson Reuters ONE
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SuppreMol GmbH
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