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Investing.com -- RAPT Therapeutics Inc (NASDAQ:RAPT) stock surged 56.3% in premarket trading Monday following the announcement of positive topline data from a Phase 2 trial of its RPT904 treatment for chronic spontaneous urticaria (CSU).
The clinical-stage biopharmaceutical company, along with its Chinese partner Shanghai Jeyou Pharmaceutical, reported that RPT904 demonstrated comparable efficacy and safety to omalizumab, the current standard of care, but with significantly less frequent dosing. While omalizumab requires monthly administration, RPT904 showed effectiveness with dosing intervals of 8 weeks (Q8W) and 12 weeks (Q12W).
The randomized, double-blind study enrolled 137 adult patients with CSU inadequately controlled by antihistamines. Results showed that both RPT904 dosing regimens achieved numerically greater improvements in the seven-day urticaria activity score (UAS7) compared to omalizumab at all measured timepoints.
By week 16, 45.65% of patients in the Q8W arm and 43.48% in the Q12W arm achieved complete symptom resolution (UAS7=0), compared to 33.33% in the omalizumab group. The drug was well tolerated with no serious adverse events related to treatment.
"These data exceeded our expectations by not only showing comparable efficacy and safety to omalizumab at Q12W dosing, but also showing durability after a single dose out to Week 16," said Brian Wong, President and CEO of RAPT. The company plans to discuss advancing to Phase 3 trials with regulatory authorities and intends to initiate a Phase 2b trial in food allergies before year-end.
The positive results suggest RPT904 could potentially transform treatment options for CSU patients by reducing the frequency of required doses from monthly to quarterly.
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