Avalo Therapeutics reported positive topline Phase 2 LOTUS trial results for abdakibart (AVTX-009) in moderate to severe hidradenitis suppurativa, with both dosing regimens meeting the primary endpoint of HiSCR75 response at Week 16 and showing statistically significant improvements versus placebo.
Written By: Karthik Teja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
Avalo Therapeutics reported positive topline results from the Phase 2 LOTUS trial (NCT06603077) evaluating abdakibart (AVTX-009) in adults with moderate to severe hidradenitis suppurativa (HS), with both dosing regimens meeting the study’s primary endpoint of HiSCR75 response at Week 16.
The randomized, double-blind, placebo-controlled trial enrolled 253 adults who were assigned in a 1:1:1 ratio to receive one of two abdakibart regimens or placebo over a 16-week treatment period. Patients received either a 600 mg loading dose followed by 300 mg every four weeks or a 300 mg loading dose followed by 150 mg every two weeks.
According to the company, both dose groups achieved statistically significant improvements in Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) compared with placebo. Avalo reported p-values of 0.018 for the 150 mg regimen and 0.015 for the 300 mg regimen, while the combined analysis achieved a p-value of 0.004. The company reported HiSCR75 improvements of 42.2% and 42.9% in the 150 mg and 300 mg groups, respectively, compared with a placebo response rate of 25.6%.
Abdakibart also demonstrated statistically significant benefits across key secondary endpoints, including HiSCR50 response rates, reductions in International Hidradenitis Suppurativa Severity Score System (IHS4) scores, and decreases in draining tunnel counts. Treatment responses were reported to be similar among patients regardless of prior biologic therapy exposure.
“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,” 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.”
The therapy was generally well tolerated, with treatment-emergent adverse event rates reported as similar across abdakibart and placebo groups. The most common adverse events were headache and nausea, and most events were mild to moderate in severity. Avalo said no unexpected safety findings emerged during the study, and no adverse events related to neutropenia, serious infections, or opportunistic infections were observed.
Abdakibart is an investigational humanized monoclonal antibody designed to inhibit interleukin-1 beta (IL-1β), a cytokine involved in inflammatory signaling pathways. Based on the Phase 2 findings, Avalo plans to advance abdakibart into a registrational Phase 3 program. Full LOTUS trial results are expected to be presented at an upcoming medical congress.
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About the Writer
Karthik Teja Macharla, PharmD is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.