Avalo Therapeutics Posts 42% HiSCR75 Responses, Targets Phase 3 for Abdakibart
AVTX•Avalo Therapeutics achieved HiSCR75 response rates of 42.2% with a 150 mg dose and 42.9% with a 300 mg dose at Week 16 in its Phase 2 LOTUS trial. The study also demonstrated statistically significant HiSCR50, IHS4 and draining tunnel count improvements and will advance abdakibart into a registrational Phase 3 program.
1. Phase 2 LOTUS Trial Topline Results
In a randomized, double-blind, placebo-controlled Phase 2 trial enrolling 253 adults with moderate to severe hidradenitis suppurativa, both 150 mg and 300 mg abdakibart regimens achieved the primary HiSCR75 endpoint at Week 16, delivering response rates of 42.2% (p=0.018) and 42.9% (p=0.015), the highest absolute improvements observed in trials of this size or larger.
2. Secondary Endpoints and Clinical Impact
Abdakibart demonstrated statistically significant benefits on key secondary measures including HiSCR50 response, reduction in International HS Severity Score System (IHS4) and decrease in draining tunnel count, with consistent efficacy across patients with and without prior biologic exposure.
3. Safety and Tolerability
The antibody was well tolerated, with treatment-emergent adverse event rates similar to placebo; most events were mild to moderate (headache, nausea) and no unexpected safety signals, neutropenia or serious infections were reported during the 16-week period.
4. Registrational Phase 3 Program
Buoyed by these topline results, Avalo plans to initiate a pivotal registrational Phase 3 program for abdakibart, leveraging a differentiated monthly dosing regimen to further assess efficacy and safety in the hidradenitis suppurativa population.
