Johnson & Johnson reported Phase II/III ENERGY results showing Imaavy (nipocalimab) produced statistically significant and durable haemoglobin gains in adults with warm autoimmune haemolytic anaemia (wAIHA). Patients receiving 30 mg/kg met the trial’s primary endpoint by week 24, with a mean Hgb rise ≥1 g/dL observed as early as week one and nearly two‑thirds reaching Hgb ≥10 g/dL plus a ≥2 g/dL increase. Key secondary outcomes—patient‑reported fatigue and steroid reduction—improved from week two and were sustained through 24 weeks. The safety profile was consistent with prior studies, and 115 adults were randomised with an optional 144‑week open‑label extension.
J&J’s Imaavy Shows Durable Hemoglobin Gains in Phase II/III ENERGY Trial for wAIHA
Patients treated with nipocalimab also saw nearly two-thirds achieving both Hgb ≥10g/dL and a ≥2g/dL rise from baseline by week 24. Credit: Sai Thaw Kyar / Shutterstock.com.(Sai Thaw Kyar / Shutterstock.com.)
Johnson & Johnson (J&J) has released initial results from the Phase II/III ENERGY trial showing that Imaavy (nipocalimab‑aahu) produced meaningful and durable haemoglobin (Hgb) improvements in adults with warm autoimmune haemolytic anaemia (wAIHA).
Trial Design and Primary Endpoint
The randomised, multicentre, placebo‑controlled, double‑blind study evaluated nipocalimab in adults with wAIHA. The ENERGY trial randomised 115 participants to receive nipocalimab or placebo and assessed a range of haematologic and patient‑reported outcomes over 24 weeks, with an optional 144‑week open‑label extension.
Primary Endpoint
The prespecified primary endpoint was a durable Hgb improvement: an increase of ≥2 g/dL from baseline to an absolute Hgb ≥10 g/dL, sustained across at least three visits spanning 28 days or more beginning by week 16, without rescue therapy or changes to background medication.
Key Efficacy Findings
- Patients receiving 30 mg/kg nipocalimab achieved a statistically significant and durable Hgb response by week 24 compared with placebo.
- Approximately three times as many patients on nipocalimab met the primary outcome versus placebo.
- A mean Hgb increase of ≥1 g/dL was observed as early as week one in the treated group.
- Nearly two‑thirds of treated patients achieved both Hgb ≥10 g/dL and a ≥2 g/dL rise from baseline by week 24.
Secondary Outcomes
Key secondary endpoints included patient‑reported fatigue and steroid use. Fatigue scores began improving by week two and these improvements were sustained through 24 weeks. Investigators also observed reductions in steroid use among treated patients, supporting a potential steroid‑sparing benefit.
Safety
Imaavy’s safety profile in wAIHA was consistent with previous studies in generalized myasthenia gravis. The most commonly reported adverse reactions were peripheral oedema, diarrhoea and fever. No new safety signals were reported in the trial.
Leonard Dragone, J&J’s autoantibody and rheumatology disease area leader, said: “In the first large, placebo‑controlled trial of its kind, Imaavy delivered durable haemoglobin improvements and showed no new safety signals in a disease lacking FDA‑approved therapies. This immunoselective approach targets the autoantibodies driving disease while preserving key immune functions.”
Context and Next Steps
wAIHA is an autoantibody‑driven condition with no therapies currently approved by the US Food and Drug Administration (FDA). Most treatments in use today are unapproved, relying on corticosteroids or broad immunosuppressants. The ENERGY results support further clinical development of nipocalimab and may inform regulatory and clinical discussions.
Study Size and Follow‑Up: 115 adults were randomised; after 24 weeks of double‑blind treatment, participants may enter a 144‑week open‑label extension to receive nipocalimab.
Source: Clinical Trials Arena (GlobalData). The information above is provided for general informational purposes and should not replace professional medical advice.
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