Avalo Therapeutics Achieves Positive Topline Results in Phase 2 LOTUS Trial of Abdakibart (AVTX-009) in Moderate to Severe Hidradenitis Suppurativa

Rhea-AI Summary

Avalo Therapeutics (NASDAQ: AVTX) reported positive topline Phase 2 LOTUS results for abdakibart (AVTX-009) in moderate to severe hidradenitis suppurativa on May 5, 2026. The trial met its primary endpoint HiSCR75 at Week 16 for both doses (42.2% at 150 mg, 42.9% at 300 mg; placebo 25.6%), showed significant secondary endpoint benefits, enrolled 253 adults, and observed a favorable safety profile. Avalo plans a registrational Phase 3 program and will present full results at a medical congress.

Positive

• HiSCR75 response +42.2% (150 mg) at Week 16
• HiSCR75 response +42.9% (300 mg) at Week 16
• Statistical significance achieved on primary and key secondary endpoints
• Favorable safety profile with no neutropenia- or serious-infection signals
• Registrational path advancement to planned Phase 3 program

Negative

• Placebo rate 25.6% reduces absolute treatment margin
• Results limited to 16-week topline data pending full readout
• Long-term safety and durability not yet reported

News Market Reaction – AVTX

+34.13% 1.7x vol

99 alerts

+34.13% Session close to close

+91.0% Peak Tracked

-34.0% Trough Tracked

$434.91M Market Cap

1.7x Rel. Volume

In the May 6 session, AVTX gained 34.13%, reflecting a significant positive market reaction. Argus tracked a peak move of +91.0% during that session. Argus tracked a trough of -34.0% from its starting point during tracking. Our momentum scanner triggered 99 alerts that day, indicating high trading interest and price volatility. Trading volume was above average at 1.7x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock surged +34.1% in the session following this news. A strong positive reaction aligns with t...

Analysis

The stock surged +34.1% in the session following this news. A strong positive reaction aligns with the clearly positive Phase 2 LOTUS topline data, where abdakibart achieved HiSCR75 rates of up to 42.9% versus 25.6% for placebo with statistically significant p-values. Historically, AVTX clinical-trial milestones averaged only about -0.94% moves, so a sizable gain would mark a break from past caution. Investors may also weigh the effective $750,000,000 shelf and recent insider net selling when assessing how durable such strength could be.

Key Figures

HiSCR75 response 150 mg: 42.2% (p=0.018) HiSCR75 response 300 mg: 42.9% (p=0.015) Combined HiSCR75 improvement: 42.5% vs 25.6% placebo (p=0.004) +5 more

8 metrics

HiSCR75 response 150 mg 42.2% (p=0.018) Phase 2 LOTUS, Week 16 primary endpoint

HiSCR75 response 300 mg 42.9% (p=0.015) Phase 2 LOTUS, Week 16 primary endpoint

Combined HiSCR75 improvement 42.5% vs 25.6% placebo (p=0.004) Phase 2 LOTUS, Week 16 HiSCR75

Trial enrollment 253 adults Phase 2 LOTUS HS population

Treatment duration 16 weeks Phase 2 LOTUS treatment period

Dosing regimen 1 600 mg load → 300 mg every 4 weeks Abdakibart Phase 2 LOTUS arm

Dosing regimen 2 300 mg load → 150 mg every 2 weeks Abdakibart Phase 2 LOTUS arm

Placebo HiSCR75 rate 25.6% Phase 2 LOTUS Week 16 comparator

Previous Clinical trial Reports

2 past events · Latest: Oct 29 (Positive)

Same Type Pattern 2 events

Date	Event	Sentiment	24h Move	Catalyst
Oct 29	Enrollment completion	Positive	-1.9%	Phase 2 LOTUS enrollment completed above target with ~250 patients.
Oct 08	Trial initiation	Positive	-0.0%	First patient dosed in Phase 2 LOTUS trial of AVTX-009 for HS.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical trial milestones for AVTX have previously seen slightly negative next-day moves despite constructive updates, indicating a tendency toward cautious reactions.

Recent Company History

Recent history for Avalo centers on the LOTUS program in hidradenitis suppurativa. In October 2024, the company announced first patient dosing in the Phase 2 LOTUS trial, followed by completion of enrollment, above target, in October 2025. Both were tagged clinical trial events and produced modest negative price reactions. Today’s positive Phase 2 topline results mark a transition from trial setup and enrollment milestones to efficacy and safety validation, advancing abdakibart toward a planned registrational Phase 3 program.

Key Terms

hiscr75, hiscr50, hidradenitis suppurativa, treatment-emergent adverse events, +2 more

6 terms

hiscr75 medical

"primary endpoint of HiSCR75 for both doses studied"

HiSCR75 is a clinical-trial measure used in dermatology that indicates a 75% or greater reduction in the number of painful skin lesions and abscesses compared with baseline. For investors, it is an objective signal of a drug’s effectiveness in reducing disease burden—similar to saying a treatment cuts the symptom load by three-quarters—which can strongly influence regulatory decisions, market adoption and commercial value.

hiscr50 medical

"benefit was demonstrated on key secondary endpoints of HiSCR50, change in IHS4"

HiSCR50 is a clinical trial measure used in skin disease studies that means a patient has experienced at least a 50% reduction in the number of painful lumps and boils, without new worsening complications. For investors, HiSCR50 is an objective yardstick of a drug’s effectiveness — hitting this threshold in trials can boost a treatment’s chance of regulatory approval, market acceptance, and commercial value, much like a safety rating improving consumer confidence in a new car model.

hidradenitis suppurativa medical

"for immune-mediated inflammatory diseases, today announced positive topline results ... in adults with moderate to severe hidradenitis suppurativa"

A chronic skin disease marked by recurring, painful lumps and tunnels under the skin that often leak and leave scars; it behaves like a slow-burning, recurring infection in areas with many sweat glands. For investors, it matters because the condition has few consistently effective treatments and causes long-term healthcare use, making successful new drugs, devices, or diagnostics potentially high-value opportunities while also carrying clinical-trial, regulatory and reimbursement risks.

treatment-emergent adverse events medical

"The percentage of subjects with treatment-emergent adverse events (TEAE) were similar"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

neutropenia medical

"There were no adverse events related to neutropenia, serious infections, or opportunistic infections."

Neutropenia is a medical condition where the blood has an unusually low number of neutrophils, the white blood cells that act like the body’s front-line security guards against bacterial and fungal infections. For investors, it matters because neutropenia can signal safety or tolerability problems for drugs or treatments, driving clinical trial setbacks, regulatory scrutiny, additional monitoring costs, or label warnings that can influence a company’s commercial outlook and stock value. Monitoring for neutropenia is a common part of assessing medical risk and long-term financial impact.

opportunistic infections medical

"no adverse events related to neutropenia, serious infections, or opportunistic infections."

Infections that occur when bacteria, viruses, fungi or other microbes take advantage of a weakened immune system and cause illness that they normally would not in healthy people. Investors watch these because their appearance in clinical trials, patient populations or product use can signal safety risks, affect regulatory reviews, increase treatment costs or reduce market demand—like discovering mold in a house that lowers its value and increases repair bills.

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• Successfully met primary endpoint of HiSCR75 for both doses studied, demonstrating response rates of 42.2% for 150 mg dose (p=0.018) and 42.9% for 300 mg dose (p=0.015) at Week 16, which are the highest rates observed in a trial of this size or larger
• Statistically significant benefit was demonstrated on key secondary endpoints of HiSCR50, change in IHS4 and change in draining tunnel count
• Abdakibart was well tolerated with a favorable safety profile
• Avalo plans to advance abdakibart into a registrational phase 3 program
  
  

WAYNE, Pa., May 05, 2026 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company fully dedicated to developing IL-1β based treatments for immune-mediated inflammatory diseases, today announced positive topline results from its Phase 2 LOTUS trial evaluating the efficacy and safety of abdakibart in adults with moderate to severe hidradenitis suppurativa (HS). The LOTUS trial successfully met its primary endpoint at both doses studied. Based on these data, Avalo plans to advance abdakibart into a registrational phase 3 program.

"We are proud to report that abdakibart has delivered a strong, consistent, and deep response across both the HiSCR75 and HiSCR50 endpoints in our Phase 2 trial. This achievement powerfully validates the clinical promise of IL-1β inhibition for hidradenitis suppurativa," said Garry Neil, MD, Chief Executive Officer of Avalo Therapeutics. “This de-risking data set gives us tremendous confidence to advance abdakibart into a pivotal phase 3 registrational program. With a differentiated and patient friendly potential monthly dosing regimen, we aim to offer a truly innovative mechanism of action to the HS community. Our heartfelt thank you goes to the patients, caregivers, investigators, and site teams whose dedication made this successful Phase 2 trial possible."

The LOTUS trial (NCT06603077), which enrolled 253 adults, was a randomized, double-blind, placebo-controlled parallel-group Phase 2 trial to evaluate the efficacy, safety and tolerability of abdakibart across two dose regimens and placebo in a 1:1:1 ratio over a 16-week treatment period. Subjects received either a 600mg loading dose of abdakibart followed by 300mg every four weeks or a 300mg loading dose followed by 150mg every two weeks. The trial’s primary efficacy endpoint was the proportion of patients achieving HiSCR75 at Week 16.

The Phase 2 LOTUS trial successfully met its primary endpoint at both doses studied (p=0.018 150mg, p=0.015 300mg and p=0.004 combined), demonstrating a 42.2% and 42.9% absolute improvement in HiSCR75 response rates at Week 16, respectively (42.5% combined, placebo rate 25.6%). This was the highest absolute improvement in HiSCR75 and HiSCR50 in clinical trials of this size or larger at each individual dose and on a combined dose basis. Abdakibart regimens also demonstrated statistically significant benefit across the key secondary endpoints in HiSCR50, change in IHS4 and change in draining tunnel count. Numerically favorable responder rates were observed across all other key secondary endpoints. The HiSCR75 response was similar in patients with and without prior biologic exposure.

“These Phase 2 results are highly promising for the HS community,” said Dr. John Frew, Professor of Dermatology, University of New South Wales, Sydney, Australia. “Achieving this level of improvement suggests that IL-1β inhibition with abdakibart may offer a meaningful new therapeutic option for people with HS who continue to struggle with this disease. The physical and emotional burden of HS is profound, and I am encouraged to see an investigational therapy showing such robust and clinically relevant results.”

Across the study, abdakibart was well tolerated. The percentage of subjects with treatment-emergent adverse events (TEAE) were similar across abdakibart treatment arms and placebo with the most common being headache and nausea. Most adverse events were mild to moderate, and no unexpected safety findings emerged during the 16-week treatment period. There were no adverse events related to neutropenia, serious infections, or opportunistic infections.

Avalo expects to present full results from the LOTUS trial at an upcoming medical congress.

About Avalo Therapeutics

Avalo Therapeutics (Nasdaq: AVTX) is a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases. Our lead asset, abdakibart, is an anti-IL-1β monoclonal antibody (mAb). Positive topline data was recently reported for abdakibart in a Phase 2 clinical trial in hidradenitis suppurativa (HS). We’re also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. For more information about Avalo, please visit www.avalotx.com.

About Abdakibart  

Abdakibart is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity. IL-1β is a pro-inflammatory cytokine that plays a central role in the pathogenesis of a wide range of human diseases.¹ It activates immune cells that generate proinflammatory cytokines, including IL-6, TNF-α, and IL-17. Dysregulated IL-1β signaling is a major driver of inflammation, contributing to the progression of autoimmune disorders. IL-1β inhibition has proven effective in multiple immune-mediated inflammatory diseases.^1-3

About the LOTUS Trial

The LOTUS trial is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial with two dose regimens to evaluate the efficacy, safety and tolerability of abdakibart in approximately 250 adults with moderate to severe hidradenitis suppurativa. Subjects were randomized (1:1:1) to receive either one of two dosing regimens of abdakibart 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: the proportion of patients achieving HiSCR50 and HiSCR90 as well as change from baseline in: International HS Severity Score System (IHS4), draining tunnel 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). For additional information about this trial (NCT06603077), please visit www.clinicaltrials.gov or www.lotustrial.com.

About Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic, progressive, often debilitating inflammatory skin disease that causes painful nodules, abscesses, and tunnels to form under the skin.^4-6,8 Areas commonly affected by HS include the nape of the neck, breasts, chest, armpits, abdomen, buttocks and anus, groin and genitals, and inner thighs.⁷ If not adequately and promptly treated, the chronic inflammation characteristic of HS may progress to tissue destruction and permanent scarring.^4-6,9 HS typically first presents in late adolescence or early adulthood and is estimated to affect 0.7–1.2% of the U.S. population, though some sources suggest the prevalence may be as high as 2–4%.^10,11,12

References:¹Dinarello CA. Immunol Rev. 2018;281(1):8-27. ²Kany S et al. Int J Mol Sci. 2019;20(23):6008. ³Kimball AB et al. Presented at: American Academy of Dermatology; March 8-12, 2024; San Diego, CA. ⁴Diaz MJ, et al. Curr Iss Mol Bio. 2023;45:4400-4415. ⁵Agnese ER, et al. Cureus. 2023;15(11):e49390. ⁶de Oliveira ASLE, et al. Biomolecules. 2022;12(10):1371. ⁷Ingram JR, et al. J Eur Acad Dermatol Venereol. 2022;36(9):1597-160. ⁸Sabat R, et al. The Lancet. 2025;405(10476):P420-438. ⁹Jemec GB. Clinicalpractice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158–164. ¹⁰Garg A, Kirby JS, Lavian J, Lin G, Strunk A. Sex- and Age-Adjusted Population Analysis of Prevalence Estimates for Hidradenitis Suppurativa in the United States. JAMA Dermatol. 2017;153(8):760–764. doi:10.1001/jamadermatol.2017.0201. ¹¹Ingram, John R.British Journal of Dermatology. doi:10.1111/bjd.19435. ¹²Nguyen TV, et al. J Eur Acad Dermatol Venereol. 2021;35(1):50-61.

Forward-Looking Statements

This press release includes forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995 and other federal securities laws. 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 our control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to our 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: therapeutic potential, clinical benefits and safety profiles of abdakibart (AVTX-009); plans to advance abdakibart into a registrational phase 3 program; expectations regarding timing, success and data announcements of ongoing preclinical studies and clinical trials; drug development costs, reliance on investigators and enrollment of patients in clinical trials; and our plans to develop and commercialize our current and any future product candidates and the implementation of our business model and strategic plans for our business.

Any forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements including, without limitation, risks associated with: the timing and anticipated results of our current and future preclinical studies and clinical trials, supply chain, strategy and future operations; the delay of any current and future preclinical studies or clinical trials or the development of our product candidates; the risk that the results of prior preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical studies and clinical trials, including those for abdakibart; the risk that cross-trial comparisons may not be reliable as no head-to-head trials of abdakibart have been conducted; the timing and outcome of any interactions with regulatory authorities; obtaining, maintaining and protecting our intellectual property; the availability of funding sufficient for our operating expenses and capital expenditure requirements, reliance on key personnel; regulatory risks; 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 our filings with the Securities and Exchange Commission, available at www.sec.gov. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. In addition, any forward-looking statements represent our view only as of today and should not be relied upon as representing its views as of any subsequent date. You should not rely upon forward-looking statements as predictions of future events and actual results or events could differ materially from the plans, intentions and expectations disclosed herein. Except as required by applicable law, we expressly disclaim any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For media and investor inquiries
Christopher Sullivan, CFO
Avalo Therapeutics, Inc.
ir@avalotx.com
410-803-6793

or

Meru Advisors
Lauren Glaser
lglaser@meruadvisors.com

FAQ

What were the topline HiSCR75 results for AVTX abdakibart in Phase 2 LOTUS?

Abdakibart achieved HiSCR75 response rates of 42.2% (150 mg) and 42.9% (300 mg) at Week 16. According to the company, the combined response was 42.5% versus placebo 25.6% in 253 enrolled adults, with statistical significance reported for both doses.

Does AVTX plan to start a Phase 3 trial for abdakibart and when was that announced?

Yes. Avalo plans to advance abdakibart into a registrational Phase 3 program following Phase 2 topline results. According to the company, this intention was announced on May 5, 2026 after the LOTUS trial met primary and key secondary endpoints.

How large was the Phase 2 LOTUS trial (AVTX) and what was the study design?

The LOTUS trial enrolled 253 adults and was randomized, double-blind, placebo-controlled in a 1:1:1 ratio. According to the company, treatment lasted 16 weeks with two dosing regimens and a placebo arm for efficacy and safety evaluation.

What secondary endpoint benefits did abdakibart show in the AVTX Phase 2 LOTUS trial?

Abdakibart showed statistically significant benefit on HiSCR50, change in IHS4, and draining tunnel count at Week 16. According to the company, numerically favorable responder rates were also observed across other secondary endpoints.

What safety findings did Avalo report for abdakibart (AVTX-009) in the LOTUS trial?

Abdakibart was reported as well tolerated with similar TEAE rates across arms and most events mild to moderate. According to the company, no neutropenia-related adverse events or serious/opportunistic infections were observed during 16 weeks.

How did prior biologic exposure affect HiSCR75 responses in AVTX LOTUS trial participants?

HiSCR75 responses were similar in patients with and without prior biologic exposure. According to the company, this consistency was observed across both dose groups in the 16-week LOTUS topline data.