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Avalo Therapeutics Announces Completion of Enrollment in Phase 2 LOTUS Trial of AVTX-009 for the Treatment of Hidradenitis Suppurativa
WAYNE, Pa., Oct. 29, 2025 (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 that the Company has completed enrollment in its Phase 2 LOTUS trial of AVTX-009 in adults with hidradenitis suppurativa (HS). The LOTUS trial exceeded target enrollment of 222 patients with approximately 250 patients enrolled. Topline data from the trial is exp
About this update from Avalo Therapeutics, Inc.
[{"type":"image","alt":"Avalo Therapeutics","displaySize":"","headline":null,"caption":"Avalo Therapeutics","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":161,"url":"https://media.zenfs.com/en/globenewswire.com/64359ff9edc0e46c29be0915b2a0157e"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/ANi8XHp5jL2i.Q7JsBSgWw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTIyNTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/64359ff9edc0e46c29be0915b2a0157e","width":300,"height":161}},"lazy":false},{"type":"text","content":"WAYNE, Pa., Oct. 29, 2025 (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 that the Company has completed enrollment in its Phase 2 LOTUS trial of AVTX-009 in adults with hidradenitis suppurativa (HS). The LOTUS trial exceeded target enrollment of 222 patients with approximately 250 patients enrolled. Topline data from the trial is expected in mid-2026.","length":518,"tagName":"p"},{"type":"text","content":"“The completion of enrollment in the LOTUS trial marks another important milestone in our AVTX-009 program,” said Dr. Garry Neil, Chief Executive Officer. “We are encouraged by the strong investigator and patient engagement in this trial, which reflects the high unmet need that exists for people living with HS. With AVTX-009’s high-affinity inhibition of IL-1β, we believe we are one step closer to offering a differentiated, potentially best-in-disease, treatment option for patients suffering from this chronic and painful condition.”","length":538,"tagName":"p"},{"type":"text","content":"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, safety and tolerability of AVTX-009 in approximately 250 adults with moderate to severe HS. Subjects were randomized (1:1:1) to receive either one of two dosing regimens 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: the proportion of patients achieving HiSCR50 and HiSCR90 as well as change from baseline in: In...