SuppreMol's Clinical Data in SLE for its Lead Product SM101 Accepted for Presentation at the 2014 ACR/ARHP Annual Meeting
SuppreMol GmbH, a biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases, has announced that an abstract detailing Phase IIa clinical data of SM101 in SLE patients has been accepted for presentation at the 2014 ACR/ARHP Annual Meeting, to be held in Boston, Massachusetts, USA, 14–19 November 2014.
The abstract "SM101, a Novel Recombinant, Soluble, Human FcyIIB Receptor, in the Treatment of Systemic Lupus Erythematosus: Results of a Double-Blind, Placebo-Controlled Multicenter Study" will be presented in the session "Systemic Lupus Erythematosus — Clinical Aspects and Treatment: Novel Therapies for Systemic Lupus Erythematosus" on Tuesday, 18 November at 2:30 PM EST (Presentation Number 2787).
The Phase IIa clinical trial enrolled 51 SLE patients for 6 months. Patients received 6 mg/kg or 12 mg/kg SM101 or placebo and randomized to a ratio of 2:2:1. The clinically relevant endpoints were SLEDAI, BILAG, PGA and Overall Response, equivalent to the Responder Index. SM101 showed a clear numerical dose response in all four key endpoints at 6 months. SM101 confirmed its excellent safety profile in this clinical trial.
Mike Tansey, Chief Development Officer at SuppreMol commented: "We are very excited by the promising therapeutic activity and excellent safety profile seen in this first SLE trial with SM101. Acceptance of our encouraging data for oral presentation by the ACR/ARHP Annual Meeting and the positive response we have received from our clinical advisors provide a further incentive for us to continue the expeditious development of SM101 to help patients suffering from SLE."
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