Avalo Therapeutics IND for AVTX-009 active; Phase 2 LOTUS trial in hidradenitis suppurativa to commence

Avalo Therapeutics, Inc.

FDA cleared IND for AVTX-009 (anti-IL-1β mAb) allowing Phase 2 LOTUS trial in moderate-to-severe HS.
LOTUS is a randomized, placebo-controlled trial of ~180 adults with two AVTX-009 dose regimens; primary endpoint HiSCR75 at Week 16.
First patient enrollment expected in 2024; AVTX-009 acquired in late March 2024 with IND filed ~3 months later.
Company believes AVTX-009 may be best-in-class due to target, half-life, and potency allowing convenient dosing.

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