Satellos Bioscience Inc Com V.ICO

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Targeted Markets iCo-007 - Diabetes-Related Blindness ~$3B+.

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biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, today announced that updated data from its phase 2 study of bertilimumab in patients with moderate-to-extensive bullous pemphigoid (BP) (study NCT02226146) are being presented today at the 2018 Pre-IID Pemphigus and Pemphigoid Symposium in Orlando, FL. These updated results include complete follow-up on all subjects enrolled in the study.  

Subjects in the study experienced a decline in the Bullous Pemphigoid Disease Area Index (BPDAI) Activity Score of 81% (p=0.015) at day 84 from a mean baseline score of 67, with 86% of subjects showing at least a 50% improvement in the BPDAI Activity Score and 57% showing at least a 90% improvement. Over the course of the study, subjects in the study also had improvements in pruritus, a very challenging symptom for patients with BP, and quality of life. These benefits were seen quickly, with a mean reduction in BPDAI Activity Score of 70% by day 42. For a subgroup of subjects within which lesion healing was assessed, all six showed healing of prior lesions by day 28.

These improvements were observed despite subjects receiving only three doses of bertilimumab (on days 0, 14 and 28) and modest doses of prednisone that were aggressively tapered. The mean starting dose of prednisone was 28 mg (0.33 mg/kg) which was reduced to 17 mg (0.19 mg/kg) by day 42 (p=0.022) and to 12 mg (0.15 mg/kg) by day 84 (p=0.005). 40% of subjects had a prednisone dose of 10 mg/day or less by day 42, and 58% had achieved 10 mg/day or less by day 84. The standard of care for BP patients treated with systemic steroids is a starting dose of 0.5-1.0 mg/kg tapered slowly over the course of 6-12 months, and subjects in this study received on average approximately 2,900 mg less prednisone than called for by the regimen of Joly et al (Joly et al, New Engl J Med 2002; 347:143-145) and 1,700 mg less prednisone than called for by British treatment guidelines (Venning et al, Br J Dermatol 2012: 1200-1214).   

These and additional results will be presented in an oral presentation by Neil Korman, MD, PhD, Director Clinical Trials Unit and the Murdough Family Center for Psoriasis, University Hospitals Cleveland Medical Center, and Professor of Dermatology, Case Western Reserve University School of Medicine, and a member of the Company’s Scientific Advisory Board, and in a poster to be presented by Immune’s Chief Medical and Operating Officer, Tony Fiorino, MD, PhD. Following the conference, the poster will be available on the Company’s website.

Dr. Fiorino stated, “I am gratified to have brought this important study to a close. The subjects in this study showed rapid improvement despite low doses of prednisone, which strongly suggests bertilimumab is active in bullous pemphigoid. Our next study will include a much longer treatment period, which could provide further benefits. We intend to discuss our plans for a randomized, controlled phase 2/3 study of bertilimumab in bullous pemphigoid with the FDA later this year, and we believe this next trial could serve as a registrational study in this orphan disease with no FDA-approved therapies. We expect to launch this pivotal study in 2019, using bertilimumab produced by our new manufacturing process.”