Avalo Announces First Patient Dosed in Phase 2 LOTUS Trial of AVTX-009 for the Treatment of Hidradenitis Suppurativa

Rhea-AI Summary

Avalo Therapeutics (Nasdaq: AVTX) has announced the dosing of the first patient in its Phase 2 LOTUS trial for AVTX-009, a treatment for hidradenitis suppurativa (HS). The global study will involve approximately 180 adults with moderate to severe HS, evaluating two dose regimens of AVTX-009 against a placebo. AVTX-009 is a humanized monoclonal antibody that targets interleukin-1β.

The randomized, double-blind trial will assess efficacy and safety over a 16-week treatment phase. The primary endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Secondary objectives include HiSCR50 and HiSCR90 achievement, changes in severity scores, and reduction in skin pain. Topline data is expected in 2026.

Positive

• Initiation of Phase 2 LOTUS trial for AVTX-009 in hidradenitis suppurativa
• Potential for AVTX-009 to be a best-in-class and best-in-indication treatment for HS
• Large-scale global study with 180 participants
• Multiple efficacy endpoints to assess treatment effectiveness

Negative

• Topline data not expected until 2026, indicating a long wait for results
• Potential competition from existing or developing HS treatments

Insights

Medical Research Analyst

The initiation of the Phase 2 LOTUS trial for AVTX-009 in hidradenitis suppurativa (HS) is a significant milestone for Avalo Therapeutics. This study targets a chronic, debilitating inflammatory skin condition with treatment options, positioning AVTX-009 as a potential best-in-class therapy. Key points to consider:

• The trial's design, involving 180 adults and two dose regimens, is robust and could provide compelling efficacy data.
• The primary endpoint of HiSCR75 at Week 16 is ambitious, potentially demonstrating strong efficacy if met.
• Secondary endpoints encompass various aspects of HS, which could provide a comprehensive understanding of AVTX-009's efficacy profile.
• Topline data expected in 2026 suggests a relatively long trial duration, which may impact the company's cash runway and time to market.

While this news shows progress in Avalo's pipeline, investors should note that Phase 2 results are still years away and success is not guaranteed in this challenging indication.

• Global study in approximately 180 adults with hidradenitis suppurativa to assess the efficacy and safety of two dose regimens of AVTX-009 compared to placebo
• Topline data expected in 2026

WAYNE, Pa. and ROCKVILLE, Md., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), today announced that the first patient has been dosed in the Company’s Phase 2 LOTUS trial of AVTX-009 in hidradenitis suppurativa (HS). AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity.

“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,” said Dr. Garry Neil, Chief Executive Officer and Chairman of the Board. “We look forward to releasing topline results in 2026.”

The LOTUS Trial is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial with two AVTX-009 dose regimens to evaluate the efficacy and safety of AVTX-009 in approximately 180 adults with moderate to severe hidradenitis suppurativa. Subjects will be randomized (1:1:1) to receive either one of two doses of AVTX-009 or placebo during a 16-week treatment phase. The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Secondary objectives include but are not limited to: proportion of patients achieving HiSCR50 and HiSCR90 as well as change from baseline in: International HS Severity Score System (IHS4), draining fistula count, abscess and inflammatory nodule (AN) count and patients achieving at least a 30% reduction on a numerical rating scale in Patient's Global Assessment of Skin Pain (PGA Skin Pain). The number of patients with anti-drug antibodies, safety, and tolerability will be assessed. For additional information this trial (NCT06603077), please visit www.clinicaltrials.gov.

About Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules, abscesses, and tunnels that form in areas of the body such as the armpits, groin, and buttocks, severely impacting the quality of life of affected individuals.¹ HS is often underdiagnosed or misdiagnosed and therefore estimates of HS vary between 0.2-1.7% of the population worldwide.^2-5 The exact cause of HS is not fully understood but is believed to involve a combination of genetic, hormonal, and environmental factors. While advances in treatment have been made, limited treatment options are available. IL-1β plays a crucial role in the inflammatory cascade underlying HS, contributing to tissue damage, inflammation, and disease progression. Given the involvement of IL-1β in the inflammatory process of HS, we believe therapies that target IL-1β offer a potential treatment option for HS.

About AVTX-009 

AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity. IL-1β is a central driver in the inflammatory process. Overproduction or dysregulation of IL-1β is implicated in many autoimmune and inflammatory diseases. IL-1β is a major, validated target for therapeutic intervention. There is evidence that inhibition of IL-1β could be effective in hidradenitis suppurativa and a variety of inflammatory diseases in dermatology, gastroenterology, and rheumatology.

About Avalo Therapeutics

Avalo Therapeutics is a clinical stage biotechnology company focused on the treatment of immune dysregulation. Avalo’s lead asset is AVTX-009, an anti-IL-1β mAb, targeting inflammatory diseases. Avalo also has two additional drug candidates, which include quisovalimab (anti-LIGHT mAb) and AVTX-008 (BTLA agonist fusion protein). For more information about Avalo, please visit www.avalotx.com.

Forward-Looking Statements

This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Avalo’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Avalo’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: drug development costs, timing of trials and trial results and other risks, including reliance on investigators and enrollment of patients in clinical trials; reliance on key personnel; regulatory risks; integration of AVTX-009 into our operations; general economic and market risks and uncertainties, including those caused by the war in Ukraine and the Middle East; and those other risks detailed in Avalo’s filings with the Securities and Exchange Commission, available at www.sec.gov. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Avalo expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avalo’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

References
¹Patel ZS et al. Curr Pain Headache Rep. 2017;21(12):49.
²Egeberg A, et al. JAMA Dermatol 2016;152:429–34
³Phan K, et al Biomed Dermatol 2020; 4: 2-6
⁴Jfri, A, et al. JAMA Dermatol. 2021;157(8):924-31
⁵Nguyen TV, et al. J Eur Acad Dermatol Venereol. 2021;35(1):50-61

For media and investor inquiries

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

or

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

FAQ

What is the purpose of Avalo's Phase 2 LOTUS trial for AVTX-009?

The LOTUS trial aims to evaluate the efficacy and safety of AVTX-009, a potential treatment for hidradenitis suppurativa (HS), in approximately 180 adults with moderate to severe HS.

When does Avalo (AVTX) expect topline results from the AVTX-009 LOTUS trial?

Avalo Therapeutics expects to release topline results from the Phase 2 LOTUS trial of AVTX-009 in 2026.

What is the primary endpoint of the AVTX-009 Phase 2 trial for hidradenitis suppurativa?

The primary efficacy endpoint of the LOTUS trial is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16.

How many dose regimens of AVTX-009 are being tested in the LOTUS trial?

The LOTUS trial is testing two dose regimens of AVTX-009 compared to placebo in patients with hidradenitis suppurativa.