Johnson & Johnson (NYSE:JNJ) on Thursday presented detailed results from its Phase 2/3 ENERGY study showing that IMAAVY (nipocalimab-aahu) achieved a statistically significant, durable hemoglobin response in patients with warm autoimmune hemolytic anemia (wAIHA).
The rare blood disorder occurs when the immune system mistakenly produces IgG antibodies that attack and destroy healthy red blood cells at normal body temperatures.
JNJ Drug Demonstrates Durable Hemoglobin Response
The company said patients receiving the 30 mg/kg dose experienced a rapid onset of effect and were about three times more likely to achieve durable hemoglobin improvements than those receiving a placebo over 24 weeks.
The randomized, placebo-controlled trial evaluated IMAAVY against placebo using a stringent primary endpoint focused on durable hemoglobin improvement.
To meet the endpoint, patients had to achieve a hemoglobin increase of at least 2 g/dL from baseline, maintain hemoglobin levels of at least 10 g/dL, meet the criteria across at least three visits beginning by Week 16, and avoid rescue therapy or changes to background medications.
The company designed IMAAVY to block the neonatal Fc receptor, reducing disease-driving IgG antibodies while preserving key aspects of the immune system.
Early Improvements And Secondary Benefits Observed
Patients in the 30 mg/kg treatment arm recorded an average hemoglobin increase of 1 g/dL by Week 1. No meaningful change was observed in the placebo group.
Nearly two-thirds of patients treated with IMAAVY achieved both a hemoglobin level of at least 10 g/dL and an increase of at least 2 g/dL from baseline by Week 24.
The therapy also met key secondary endpoints. Investigators observed improvements in patient-reported fatigue as early as Week 2, with benefits continuing throughout the 24-week treatment period. The study additionally showed reductions in steroid use among treated patients.
Safety Profile And Regulatory Progress
Johnson & Johnson said IMAAVY's safety profile in the trial was consistent with its established profile in generalized myasthenia gravis, its currently approved indication.
The data support the supplemental Biologics License Application for IMAAVY, which has been granted U.S. FDA Priority Review.
JNJ Stock Price Activity: Johnson & Johnson shares were up 0.93% at $240.70 at the time of publication on Thursday, according to Benzinga Pro data.
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