AVTX-009 / Avalo Therap, Eli Lilly - LARVOL DELTA

Avalo Therapeutics Reports 2025 Financial Results and Recent Business Updates (The Manila Times) - "Abdakibart (AVTX-009) Phase 2 LOTUS trial: The global study which includes approximately 250 adults with hidradenitis suppurativa (HS) is designed to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo: Topline data expected in the second quarter of 2026."

P2 data • Hidradenitis Suppurativa

LOTUS: A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=250 | Active, not recruiting | Sponsor: Avalo Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Hidradenitis Suppurativa • Immunology

Avalo Therapeutics Highlights AVTX-009 HS Phase II Catalyst, Cash Runway at Oppenheimer Conference (MarketBeat) - "Avalo expects to report top-line Phase II data from its LOTUS trial in the second quarter, and the company is using HiSCR75 as the primary endpoint...Looking ahead, Neil said Avalo intends to engage the FDA at an end-of-Phase II meeting and noted recent discussion suggesting a single pivotal trial may be sufficient for many approvals. He said the company will explore whether it can pursue a more efficient approach, while also describing the more typical HS pathway as two well-controlled studies with a 16-week induction period followed by 52-week follow-up."

New P3 trial • P2 data • Hidradenitis Suppurativa

Avalo Therapeutics Highlights AVTX-009 Progress in HS (The Globe and Mail) - "The company reported that enrollment has been completed in its Phase 2 LOTUS trial in HS, with topline data expected in the second quarter of 2026..."

Enrollment closed • P2 data • Hidradenitis Suppurativa

LOTUS: A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=250 | Active, not recruiting | Sponsor: Avalo Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2026 ➔ Apr 2026 | Trial primary completion date: Jun 2026 ➔ Mar 2026

Enrollment closed • Trial completion date • Trial primary completion date • Dermatology • Hidradenitis Suppurativa • Immunology

Avalo Therapeutics Announces Completion of Enrollment in Phase 2 LOTUS Trial of AVTX-009 for the Treatment of Hidradenitis Suppurativa (GlobeNewswire) - "The LOTUS trial exceeded target enrollment of 222 patients with approximately 250 patients enrolled. Topline data from the trial is expected in mid-2026."

Enrollment closed • P2 data • Hidradenitis Suppurativa

Avalo Reports First Quarter 2025 Financial Results and Recent Business Updates (GlobeNewswire) - "Phase 2 LOTUS trial: The global study design includes approximately 180 adults with HS to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo; Topline data is expected in 2026; Second Indication Exploration: Avalo continues to evaluate AVTX-009 for additional immune-mediated diseases with plans to announce a second indication."

P2 data • Pipeline update • Hidradenitis Suppurativa

Avalo Reports 2024 Financial Results and Recent Business Updates (GlobeNewswire) - "Topline data from Phase 2 LOTUS Trial of AVTX-009 for the treatment of hidradenitis suppurativa expected in 2026."

P2 data • Hidradenitis Suppurativa

Avalo Announces First Patient Dosed in Phase 2 LOTUS Trial of AVTX-009 for the Treatment of Hidradenitis Suppurativa (GlobeNewswire) - "Avalo Therapeutics...announced that the first patient has been dosed in the Company’s Phase 2 LOTUS trial of AVTX-009 in hidradenitis suppurativa (HS)....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."

Trial status • Hidradenitis Suppurativa

LOTUS: A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients with Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Avalo Therapeutics, Inc.

New P2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

Avalo Therapeutics Announces Active IND for AVTX-009, an anti-IL-1β mAb, to Treat Hidradenitis Suppurativa (GlobeNewswire) - "Avalo Therapeutics...announced that the Investigational New Drug (IND) for AVTX-009, an anti-IL-1β monoclonal antibody (mAb), for the treatment of hidradenitis suppurativa (HS) is now active, permitting the Company to commence its Phase 2 (LOTUS) clinical trial in patients with HS. Avalo expects to enroll the first patient in its Phase 2 LOTUS Trial this year....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 HS. The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16."

IND • New P2 trial • Hidradenitis Suppurativa

Avalo Acquires Anti-IL-1β mAb and Announces Private Placement Financing of up to $185 Million (GlobeNewswire) - "Avalo Therapeutics...announced it has acquired a Phase 2-ready anti-IL-1β mAb, which it refers to as AVTX-009, through the acquisition of privately held AlmataBio, Inc....The private placement will provide up to $185 million in gross proceeds, including an initial gross upfront investment of $115.6 million....Avalo intends to pursue the development of AVTX-009 in hidradenitis suppurativa (HS). Topline results from a planned Phase 2 trial in HS are expected in 2026 and the upfront funding is expected to fund operations through this data readout and into 2027. In addition to HS, Avalo intends to develop AVTX-009 in at least one other chronic inflammatory indication."

M&A • New P2 trial • Hidradenitis Suppurativa • Inflammation