Novartis SEG101 (crizanlizumab, formerly SelG1) significantly reduces frequency of sickle cell pain crises in Phase II study

Novartis International AG / Novartis SEG101 (crizanlizumab, formerly SelG1) significantly reduces frequency of sickle cell pain crises in Phase II study . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• SEG101 reduced annual rate of sickle cell-related pain crises (SCPC) by 45.3% compared to placebo in patients with or without hydroxyurea therapy
   

SEG101 is a potential new disease-modifying, preventive treatment option for patients with SCPC; first in nearly 20 years
 

Data being highlighted in ASH 2016 media briefing, presented at Plenary Scientific Session and published simultaneously in The New England Journal of Medicine

Basel, December 3, 2016 - Results from the Phase II SUSTAIN study show that SEG101 (crizanlizumab, formerly SelG1), an anti-P-selectin antibody, reduced the median annual rate of sickle cell-related pain crises (SCPC) by 45.3% compared to placebo (1.63 vs 2.98, p=0.010) in patients with or without hydroxyurea therapy[1]. Novartis today announced that the data are being featured in the official press briefing at the 58^th American Society of Hematology (ASH) Annual Meeting and presented during the Plenary Scientific Session tomorrow (Abstract #1, 2:00 - 4:00 p.m. PST). The results also are being published simultaneously in The New England Journal of Medicine.

"Acute painful episodes, commonly referred to as vaso-occlusive crises, are a substantial cause of morbidity in sickle cell disease with limited treatment options," said Kenneth I. Ataga, M.D., Division of Hematology/Oncology, University of North Carolina, Chapel Hill. "These findings show that crizanlizumab significantly reduces the frequency of painful crises and represents a potentially novel disease-modifying therapeutic option." 

In the SUSTAIN study, patients were assigned to high-dose (5.0 mg/kg), low-dose (2.5 mg/kg) and placebo arms. The study met its primary endpoint, reduction of the annual rate of SCPC in the high-dose arm by 45.3% vs. placebo (medians of 1.63 vs. 2.98, p=0.010). In the low- dose arm, the annual rate of SCPC was reduced by 32.6% vs. placebo (medians of 2.01 vs. 3.0, p = 0.180). For patients in the high dose arm, time to first SCPC vs. placebo was 2.9 times longer (medians of 4.07 vs. 1.38 months, p = 0.001) and time to second SCPC was 2.0 times longer than placebo (medians of 10.32 vs. 5.09 months, p = 0.022)[1].