Rallybio Sees Complete Complement Inhibition at 300 mg, Plans Phase 2 in H2 2026
Phase 1 trial of RLYB116 achieved complete, sustained terminal complement inhibition at a 300 mg weekly dose with mild injection site reactions and no severe adverse events. Rallybio will initiate a Phase 2 trial for immune platelet transfusion refractoriness in the second half of 2026, targeting topline data in 2027.
1. Phase 1 Trial Results
The Phase 1 PK/PD study of RLYB116 demonstrated complete and sustained inhibition of terminal complement at a weekly 300 mg dose, confirming clinically effective blockade of ex vivo hemolytic activity and promising pharmacokinetic profiles at both 150 mg and 300 mg cohorts.
2. Safety and Tolerability
RLYB116 was well tolerated with only mild-to-moderate injection site reactions reported and no gastrointestinal side effects or severe adverse events, and no participants discontinued the study drug.
3. Phase 2 Trial Plans
Rallybio plans to initiate a Phase 2 clinical trial for immune platelet transfusion refractoriness in the second half of 2026, with topline efficacy and safety data expected in 2027.
4. Stock Performance and Technical Indicators
Shares trade 4.5% below its 20-day SMA and 8.2% below its 100-day SMA, reflecting bearish momentum alongside a 17.97% decline over the past 12 months; RSI remains neutral while the MACD sits below its signal line, indicating mixed near-term direction.