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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 Result summary20 Oct, 2025
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.
RPT904's bio-better regulatory strategy?
Market impact of RPT904's Q12W dosing?
Rationale for RPT904 food allergy trial?
RPT904's durability advantage over Xolair?
Phase III CSU trial design and regulatory path
RPT904's food allergy market differentiation?
Assess RPT-904's optimal Phase 3 dosing.
RPT-904's market position vs. new CSU therapies.
Impact of CSU data on food allergy trial.
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Next RAPT Therapeutics earnings date
Q3 202511 Nov, 2025
Next RAPT Therapeutics earnings date
Q3 202511 Nov, 2025
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Frequently asked questions
RAPT Therapeutics Inc. is a clinical-stage biopharmaceutical company specializing in immunology-based treatments. The company's primary focus is on discovering, developing, and commercializing oral small molecule therapies for significant unmet needs in inflammatory diseases and cancer. Utilizing a proprietary drug discovery and development engine, RAPT Therapeutics designs highly selective small molecules aimed at modulating critical immune responses. The company's pipeline includes drug candidates targeting CCR4 and other key immune pathways, with ongoing development for conditions such as atopic dermatitis and various cancers. RAPT Therapeutics is headquartered in South San Francisco, California, and its shares are listed on the NASDAQ.
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