Avalo Therapeutics Embarks on Phase 2 LOTUS Trial for HS

Avalo Therapeutics Embarks on Clinical Journey with AVTX-009

Avalo Therapeutics, Inc. (NASDAQ: AVTX) is thrilled to share that the first patient has been dosed in their Phase 2 LOTUS trial focused on honoring patients suffering from hidradenitis suppurativa (HS). This promising study aims to provide new insights into the treatment of this chronic skin condition, which has a profound impact on the quality of life for those affected.

Understanding Hidradenitis Suppurativa

Hidradenitis suppurativa is characterized by painful nodules and abscesses that form in various body areas, significantly affecting individual quality of life. Often underdiagnosed or misdiagnosed, the prevalence of HS varies, affecting approximately 0.2% to 1.7% of the global population. While the exact cause remains unclear, factors such as genetics, hormones, and the environment may contribute to its development.

The Importance of Treating HS

Despite the need for more effective treatment options, many individuals with HS still lack comprehensive care solutions. Current therapies may not adequately address the underlying inflammatory processes. Interleukin-1? (IL-1?), a critical player in this inflammation, presents a fascinating target for potential therapy. Medications that effectively inhibit IL-1?’s activity have the potential to offer significant relief to those living with HS.

About the LOTUS Trial

The LOTUS trial is an innovative, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of AVTX-009, a humanized monoclonal antibody. Approximately 180 adults with moderate to severe hidradenitis suppurativa will participate in this study. Participants will receive either one of two doses of AVTX-009 or a placebo over a 16-week treatment period.

Trial Objectives and Outcomes

The primary objective is to assess the proportion of subjects achieving a significant clinical response, particularly Hidradenitis Suppurativa Clinical Response (HiSCR75), at 16 weeks. Secondary goals include evaluating other clinical scores, patient-reported pain levels, and key safety parameters. Monitoring patients for anti-drug antibodies, among other tolerability assessments, will provide a comprehensive view of AVTX-009's profile during the trial.

Excitement from the Leadership Team

Dr. Garry Neil, the CEO of Avalo Therapeutics, expressed enthusiasm regarding this significant milestone: “The Avalo team has efficiently executed to achieve this important milestone and we are excited to have this trial underway. Hidradenitis suppurativa is a disease that can significantly impact quality of life, and there is a need for improved treatment options. We believe AVTX-009’s high potency could make it a best-in-class and best-in-indication treatment option for patients suffering from hidradenitis suppurativa.”

Potential of AVTX-009

AVTX-009 has caught the attention of the medical community due to its unique mechanism. As a humanized monoclonal antibody targeting IL-1?, it holds promise not only for HS but also for various other inflammatory diseases. With growing evidence that supports its effectiveness in treating autoimmune and inflammatory conditions, this therapy could represent a breakthrough for many patients.

Avalo’s Commitment to Innovation

Avalo Therapeutics remains dedicated to advancing its portfolio, addressing immune dysregulation through innovative therapeutic solutions. Alongside AVTX-009, Avalo is developing additional candidates that target critical pathways in inflammatory diseases. The focus on advancing potential therapies demonstrates Avalo’s commitment to improving patient outcomes.

Contact Information for Inquiries

For media and investor inquiries, please contact:

Christopher Sullivan, CFO
Avalo Therapeutics, Inc.
Email: ir@avalotx.com
Phone: 410-803-6793

or

Chris Brinzey
ICR Westwicke
Email: Chris.brinzey@westwicke.com
Phone: 339-970-2843

Frequently Asked Questions

What is the LOTUS trial?

The LOTUS trial is a Phase 2 clinical study evaluating the efficacy and safety of AVTX-009 in patients with hidradenitis suppurativa.

What is AVTX-009?

AVTX-009 is a humanized monoclonal antibody that targets interleukin-1?, a key mediator of inflammation in various autoimmune diseases.

How many patients will be involved in the LOTUS trial?

Approximately 180 adults with moderate to severe hidradenitis suppurativa are expected to participate in the trial.

What are the goals of the LOTUS trial?

The trial aims to evaluate the proportion of patients achieving significant clinical improvement and to assess safety and tolerability.

When can we expect results from the LOTUS trial?

Topline results from the trial are expected to be released in the future, with significant interest from the medical community.

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