SBI-087 at the EULAR 2012

SBI-087 has been evaluated in a phase 2 study. IT’s called a SMIP and SMIP has been trade marked as SMIP™ and means mono-specific protein therapeutic. Wyeth also has another SMIP™ in the pipeline, TRU-015, of which I haven’t seen anything, yet. SBI-087 is a humanized SMIP™, which is directed at B cell and leads to a dose dependant B cell depletion. The drug is administered subcutaneously twice per day, evaluation has been done with groups having received one day of treatment, two days at different times and three days. The subcutaneous injections have been done “in combination with 40 mg oral prednisone or equivalent, acetaminophen, and an antihistamine prior to dosing and 20 mg oral prednisone or equivalent 4 hours post dose.” So; we’re already in the study presented by N. Damjanov and colleagues. ACR20 reached 70% in the three days treatment group. “The DAS28 mean changes from baseline at week 16 were -2.12 in the Day 1, 15, and Week 12 arm versus -1.52 in the placebo arm (p<0.05).” In adverse events there were leukopenia and others like headache, diarrhea, nausea, and increased ALT, but also pyrexia despite the premedication. The authors concluded for positive results.

[OP0024] SAFETY AND EFFICACY OF SBI-087 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS IN A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
N. Damjanov1, M. Tlustochowicz2, J. Aelion3, A. Dimic4, M. Greenwald5, A. Diehl6, I. Bhattacharya7, S. Menon7, I. Gourley6. 1Belgrade University School of Medicine, Belgrade, Serbia; 2Wojskowy Instytut Medyczny, Warsaw, Poland; 3Arthritis Center, Jackson, United States; 4Institute for Treatment and Rehabilitation, Niska Banja, Serbia; 5Desert Medical Advances, Palm Desert; 6Pfizer Inc., Collegeville; 7Pfizer Inc., Cambridge, United States
Conclusions: SBI-087 administered subcutaneously was generally well tolerated. The 200 mg SBI-087 Day 1, 15, and Week 12 treatment arm achieved significant improvement in RA disease activity by week 16 compared to placebo.

It seems that B cell depletion will become easier in the future. On the other hand, if patients might suffer from immediate adverse events, you don’t want them to do so alone, so the advantage of a SC injections melts away.

30.11.2016:
Interestingly Adinsight informs that all phase 1 and 2 studies have been discontinued. B cell depletion hasn't become easier. We had seen ofatumumab, ocrelizumab, and veltuzumab being taken off the study in regard of rheumatoid arthritis earlier.
Links:
http://adisinsight.springer.com/drugs/800027994 
http://rheumatologe.blogspot.de/2012/06/anti-cd-20-monoclonal-antibody.html  

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