Avalo Therapeutics Advances in Hidradenitis Suppurativa Treatment
Avalo Therapeutics Celebrates Enrollment Milestone in LOTUS Trial
Wayne, PA - Avalo Therapeutics, Inc. (NASDAQ: AVTX), known for its commitment to advancing treatments for immune-mediated inflammatory diseases, proudly announces the successful completion of patient enrollment in its Phase 2 LOTUS trial of AVTX-009, specifically targeting adults afflicted with hidradenitis suppurativa (HS). Exceeding the anticipated recruitment of 222 participants, the trial has enrolled approximately 250 patients, a promising indication of the study's significance. Topline data is expected to be released in the middle of 2026.
CEO Insights on Trial Significance
Dr. Garry Neil, the Chief Executive Officer, expressed his enthusiasm, stating, "The completion of enrollment in the LOTUS trial marks another important milestone in our AVTX-009 program. We are encouraged by the strong investigator and patient engagement in this trial, highlighting the pressing unmet need in treating HS. With AVTX-009's potent inhibition of IL-1?, we’re moving forward towards providing a possibly groundbreaking treatment option for those battling this chronic and distressing condition."
LOTUS Trial Design and Expected Outcomes
The LOTUS trial is meticulously designed as a randomized, double-blind, placebo-controlled study, structured to evaluate AVTX-009’s efficacy, safety, and tolerability among approximately 250 adults suffering from moderate to severe HS. Participants will receive one of two dosing regimens of AVTX-009 or a placebo over a 16-week treatment period. The primary endpoint focuses on the proportion of patients achieving a significant clinical response, measured by the Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Additional metrics will include the percentage of subjects attaining HiSCR50 and HiSCR90, along with improvements in various assessments of HS severity and patient-reported skin pain metrics.
Learn More About the Trial
For those interested in the specifics related to the LOTUS trial, including detailed eligibility criteria and outcome measures, please refer to ClinicalTrials.gov.
About Avalo Therapeutics
Avalo Therapeutics operates at the forefront of biotechnology, focusing on developing innovative treatments based on IL-1? for immune-mediated inflammatory diseases. With AVTX-009 currently in Phase 2 trials for HS, Avalo is also exploring additional avenues to address significant unmet medical needs. Visit Avalo's official website for more comprehensive insights into their mission and pipeline.
About AVTX-009
AVTX-009 is a humanized monoclonal antibody designed to effectively neutralize the inflammatory activity of interleukin-1? (IL-1?). Recognized as a crucial pro-inflammatory cytokine in various diseases, IL-1?’s dysregulated signaling promotes inflammation and contributes to the severity of autoimmune disorders. Targeting IL-1? with AVTX-009 has shown promise across multiple immune-mediated inflammatory conditions, and the ongoing studies aim to reinforce its potential effectiveness.
Media and Investor Communication
Avalo Therapeutics welcomes inquiries from media representatives and investors alike. For investor relations, please reach out to Christopher Sullivan, CFO, directly via email at ir@avalotx.com or by phone at 410-803-6793. For media concerns, you may also contact Lauren Glaser at Meru Advisors via email.
Frequently Asked Questions
What is the primary focus of AVTX-009?
AVTX-009 aims to target and neutralize IL-1?, a key player in inflammatory processes relevant to diseases like hidradenitis suppurativa.
When can we expect data results from the LOTUS trial?
The topline data from the LOTUS trial is anticipated to be released in mid-2026.
What does the LOTUS trial evaluate?
The LOTUS trial assesses the efficacy, safety, and tolerability of two dosing regimens of AVTX-009 in treating moderate to severe hidradenitis suppurativa.
Who can participate in the LOTUS trial?
The trial includes adults diagnosed with moderate to severe hidradenitis suppurativa, and specific eligibility criteria apply.
How does IL-1? affect humans?
IL-1? is a pro-inflammatory cytokine that can lead to significant inflammation and is involved in various autoimmune diseases when dysregulated.
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