Johnson & Johnson (J&J) has reported the first outcomes from the Phase II/III ENERGY trial, indicating that Imaavy (nipocalimab-aahu) led to a significant haemoglobin (Hgb) improvement in patients with warm autoimmune haemolytic anaemia (wAIHA).
The randomised, multi-centre, placebo-controlled, double-blind trial is assessing the efficacy of nipocalimab in adults with wAIHA.
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It demonstrated that patients in the 30mg/kg nipocalimab group showed a statistically significant and durable Hgb response by week 24.
The trial also showed nearly three times as many patients achieved this outcome compared to placebo, with a mean Hgb increase of at least 1g/dL observed by week one.
Patients treated with nipocalimab also saw nearly two-thirds achieving both Hgb ≥10g/dL and a ≥2g/dL rise from baseline by week 24.
The ENERGY study defined its primary endpoint as a durable Hgb improvement of ≥2g/dL from baseline, with an Hgb concentration of ≥10g/dL, sustained across at least three visits for 28 days or more starting by week 16, without rescue therapy or changes to background medication.
Improvements in fatigue and reduced steroid use were key secondary endpoints, with patient-reported fatigue decreasing as early as week two and sustained through 24 weeks.
Imaavy displayed a safety profile similar to that observed in the treatment of generalised myasthenia gravis. The most frequent adverse reactions reported in wAIHA patients were peripheral oedema, diarrhoea, and fever.
wAIHA is an autoantibody-driven disease for which there are currently no therapies approved by the US Food and Drug Administration (FDA).
Most available therapies for wAIHA are unapproved and include corticosteroids or broad immunosuppressants.
J&J autoantibody and rheumatology disease area leader Leonard Dragone said: “In the first large, placebo-controlled trial of its kind, Imaavy delivered durable improvements in haemoglobin levels and showed no new safety signals, in a disease with no FDA-approved therapies.
“This immunoselective approach targets the underlying autoantibodies driving disease while preserving key immune functions, which is important for people living with this disease who frequently suffer from comorbid conditions.”
The ENERGY trial randomised 115 adults to nipocalimab or placebo. After completing the double-blind treatment for 24 weeks, patients are eligible for an open-label extension period to receive nipocalimab for a period of 144 weeks.
