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RAPT Therapeutics (RAPT) investor relations material
RAPT Therapeutics Study Result summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study overview and design
Randomized, double-blind, active-controlled Phase II trial in adults with chronic spontaneous urticaria (CSU) inadequately controlled by H1 antihistamines, conducted in China with ex-China rights held by the sponsor.
135–137 patients were randomized to RPT-904 300 mg every 8 or 12 weeks, or omalizumab 300 mg every 4 weeks, for a 16-week treatment period.
Primary endpoint was change from baseline in UAS7 at weeks 8, 12, and 16; secondary endpoints included complete response (UAS7=0), itch/hive severity, angioedema, and quality of life.
Baseline demographics and disease severity were well balanced across arms, with mean age around 40 years and only ~10% with prior omalizumab exposure.
Completion rates exceeded 94% across all arms.
Efficacy and safety results
Both RPT-904 dosing regimens showed numerically superior or comparable efficacy to omalizumab on UAS7 and complete response rates at all time points.
At week 16, RPT-904 Q8 and Q12 week arms showed 23.2 and 22.2 point improvements in UAS7, versus 19.1 for omalizumab.
Complete response rates (UAS7=0) at week 16 were 46% (Q8), 44% (Q12), and 32% (omalizumab).
Efficacy was durable, with sustained response at week 16 after a single dose of RPT-904 Q12W.
No drug-related serious adverse events, discontinuations, or anaphylaxis were reported; safety profile was favorable and similar across groups.
Mechanism, competitive landscape, and future plans
RPT-904 is a next-generation, half-life extended anti-IgE antibody with higher affinity, improved manufacturability, and less frequent dosing compared to omalizumab.
It blocks IgE binding and removes IgE from mast cells/basophils, downregulating FcεRI and desensitizing cells.
Market research suggests RPT-904's dosing schedule may improve compliance and clinical outcomes, potentially making it the preferred advanced therapy for CSU.
Plans include advancing to Phase III in CSU, initiating a Phase IIb trial in food allergy, and future studies in asthma.
Additional efficacy and safety data will be presented at future medical conferences.
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