Avalo Therapeutics (AVTX) TD Cowen 46th Annual Health Care Conference summary

Strategic focus and asset differentiation

• AVTX-009 is a high-affinity monoclonal antibody targeting IL-1 beta, central to HS inflammation, aiming for best-in-disease status due to its potency, half-life, and dosing regimen.

• IL-1 beta is a key driver of chronic inflammation in HS, while IL-1 alpha plays a different, less relevant role.

• High affinity and bioavailability are emphasized as competitive advantages over other IL-1 inhibitors, including lutikizumab and MAS825.

• Direct targeting of IL-1 beta is considered more efficient than indirect approaches like IL-1 receptor antagonists.

Competitive landscape and clinical validation

• Prior IL-1 inhibitors (anakinra, canakinumab) and recent bispecifics (MAS825) show efficacy signals but are limited by potency, half-life, or dosing.

• AbbVie's lutikizumab Phase II data in severe, bio-experienced HS patients is seen as strong proof of concept for IL-1 beta inhibition.

• AVTX-009 claims 7–10x higher affinity for IL-1 beta than lutikizumab, potentially enabling superior efficacy in difficult-to-treat lesions.

• The trial design leverages experienced dermatologists and rigorous training to optimize endpoints and minimize placebo effects.

Clinical trial design and expectations

• Phase II trial powered with over 250 patients, expanded from 180 to enable robust subpopulation analyses.

• HiSCR 75 is the primary endpoint, with placebo rates expected at 13–18%; efficacy goal is >20% placebo-adjusted difference, with 25% considered a home run.

• Data readout expected within 4–8 weeks after last patient out, which should occur by end of March.

• Subgroup analyses will address efficacy in both bio-experienced and bio-naive patients, including those who failed TNF and IL-17 therapies.