Novartis announces new crizanlizumab (SEG101) data analysis in sickle cell disease, and investment in SENTRY clinical program - Seite 2

In the analysis of the per protocol population of the 52-week SUSTAIN study, which compared the P-selectin inhibitor crizanlizumab with placebo in patients with sickle cell disease, crizanlizumab (5.0 mg/kg) significantly:

• Increased the percentage of patients who did not experience any VOCs vs placebo (37.5% vs. 12.2%, p=0.008) during treatment
• More than doubled the median time to first on-treatment VOC (6.55 vs 1.58 months, p < 0.001) and

Decreased the annual rate of VOCs (1.04 vs 2.18, p=0.02).

SUSTAIN is part of the SENTRY clinical trial program including seven active or planned clinical studies designed to generate an array of additional data on the role crizanlizumab plays in the management of sickle cell disease. More studies may be added as plans are finalized.

Major active trials in the SENTRY program include:

• SOLACE-adults (A2202) Phase II study investigating the pharmacological properties and safety of crizanlizumab in patients with sickle cell disease aged 16 and above
• SOLACE-kids (B2201) Phase II study investigating the safety and efficacy of crizanlizumab in pediatric patients with sickle cell disease
• STAND (A2301) Phase III study investigating the efficacy and safety of crizanlizumab in sickle cell disease patients aged 12 and above
• SUCCESSOR retrospective cohort study among adult sickle cell disease patients in the US

"The SENTRY program emphasizes our long-term commitment to reimagining sickle cell disease treatment for as many people as possible," said Samit Hirawat, MD, Head, Novartis Oncology Global Drug Development. "The outcomes of these trials, alongside our analyses of SUSTAIN, will increase our understanding of the disease and, we hope, take us a step forward in our aspiration to reduce the burden of sickle cell pain crises."

About the SUSTAIN trial
The Phase II SUSTAIN trial was a multicenter, multinational, randomized, placebo-controlled, double-blind,12-month study to assess safety and efficacy of the anti-P-selectin antibody crizanlizumab with or without concomitant use of hydroxyurea therapy in sickle cell disease patients with sickle cell-related pain crises. Primary results were published in The New England Journal of Medicine and showed that crizanlizumab reduced the median annual rate of sickle cell pain crises (SCPCs) by 45.3% compared to placebo (1.63 vs 2.98, p=0.010) in patients with or without hydroxyurea therapy[6].