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Avalo Therapeutics (AVTX) investor relations material
Avalo Therapeutics Piper Sandler 37th Annual Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Key announcements and data updates
Top-line data from the phase II LOTUS trial in HS with AVTX-009 will be available in Q2, following last patient visits at the end of March and subsequent data analysis.
Enrollment for the LOTUS trial was completed on October 29, with 250 patients enrolled, exceeding the original target of 222, making it one of the largest phase II HS trials.
The study is powered at 80% to detect a 20% delta in HiSCR75 and 90% for a 25-30% delta, with over one-third of patients being biologically experienced.
Subgroup analyses, including bio-experienced versus naive patients, are planned for the top-line data release.
Study design and operational rigor
Approximately 90 sites participated, mainly in the US and Canada, with strict site and investigator qualification and training protocols.
Board-certified dermatologists led most sites, and both investigators and patients underwent specialized training to minimize placebo effects.
Continuous monitoring and retraining ensured data consistency, and site enrollment was capped to avoid bias.
The CRO selected had prior success in similar studies, and operational measures were implemented to maintain steady, high-quality enrollment.
Competitive positioning and future plans
The preferred phase III dose is likely the every-four-week regimen, pending FDA discussions and phase II results.
The program is designed to meet regulatory requirements for two pivotal studies, with dose selection informed by efficacy and safety data.
AVTX-009 is positioned to differentiate from lutikizumab through higher potency, longer dosing intervals, and potentially superior efficacy.
The mechanism targets IL-1 beta, with potential for broader application in dermatology, GI, and rheumatology, including crystal arthropathies.
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