Clinical TrialMay 5, 2026, 04:02 PM
Avalo's Abdakibart Phase 2 HS Trial Meets Primary Endpoint
AI Summary
Avalo Therapeutics announced positive topline results from its Phase 2 LOTUS trial for abdakibart in moderate to severe hidradenitis suppurativa (HS). The trial successfully met its primary endpoint, demonstrating HiSCR75 response rates of 42.2% for the 150 mg dose and 42.9% for the 300 mg dose at Week 16, which are the highest rates observed in a trial of this size or larger. Abdakibart was well tolerated with a favorable safety profile, leading Avalo to plan for a registrational Phase 3 program.
Key Highlights
- Abdakibart Phase 2 LOTUS trial met primary endpoint (HiSCR75) for moderate to severe hidradenitis suppurativa (HS).
- 150 mg dose achieved 42.2% HiSCR75 response rate (p=0.018) at Week 16.
- 300 mg dose achieved 42.9% HiSCR75 response rate (p=0.015) at Week 16.
- These response rates are the highest observed in a trial of this size or larger.
- Statistically significant benefit was demonstrated on key secondary endpoints including HiSCR50.
- Abdakibart was well tolerated with a favorable safety profile.
- Avalo plans to advance abdakibart into a registrational Phase 3 program.
- The LOTUS trial enrolled 253 adults over a 16-week treatment period.