Avalo Therapeutics (AVTX) presented its pipeline progress at the 12th Annual Cantor Fitzgerald Global Healthcare Conference on Thursday, detailing plans for a Phase III program centered on abdakibart (AVTX-009), a high-potency anti-IL-1 beta monoclonal antibody.
Shares of Avalo, trading near $17.76, have returned 65% over the past year. The company holds a market capitalization of approximately $976.6 million, carries no debt and maintains a current ratio of 19.31. CEO Garry Neil said cash on hand is sufficient to fund the Phase III top-line readout, development of the long-acting AVTX-010 program, and one additional proof-of-concept study without requiring near-term capital raises.
The Phase IIb LOTUS trial in moderate-to-severe hidradenitis suppurativa (HS) reported HiSCR 75 efficacy in the low-to-mid-40% range, with consistent benefit across HiSCR 50, HiSCR 90 and IHS4 endpoints. Responses were observed in both biologically naive patients and those previously exposed to IL-17 therapy, and Neil highlighted notable healing of draining tunnels — a feature often difficult to achieve with existing therapies.
Neil noted that historical placebo response rates in HS trials typically range from 13% to 18%, occasionally reaching the 20% range. "What you learn from that is that it's not that you stay away from disease areas or categories where you have a high placebo response. You design the trial in a way that you're going to be successful and show the effect," he said. "I'm super confident about the Phase III program because of the consistency of the response."
The proposed Phase III design calls for a 16-week induction phase followed by a 52-week chronic treatment period, with HiSCR 75 and HiSCR 50 as primary endpoints and IHS4 and tunnel healing as secondary endpoints. Dosing would consist of a 600 mg loading dose followed by 300 mg every four weeks — a once-monthly maintenance schedule that contrasts with AbbVie's once-weekly induction dosing for its competing IL-1 beta program, lutikizumab. The auto-injector is designed for simple self-administration.
When comparing abdakibart to AbbVie's lutikizumab, Neil said the combined Phase III data from both programs is "very convincing for the IL-1 beta hypothesis." He added that while AbbVie has a drug hitting that target, "ours hits it harder and more selectively, so I think that's going to be in our favor."
Avalo also discussed expansion into other indications. Crystal arthropathy, specifically calcium pyrophosphate deposition disease (CPPD), was flagged as a potential opportunity, affecting an estimated 10 million people overall, with roughly 1 million to 2 million severe enough to potentially justify biologic treatment. No approved therapies currently exist for the condition. Other potential indications include neutrophilic dermatoses such as pyoderma gangrenosum, severe acne and PASH syndrome.
Neils said the FDA plans to submit an End-of-Phase 2 package before the end of 2026, with the next indication announcement targeted for fall or earlier next year. The Phase III program aims to conclude by 2029.
AVTX-010, the company's long-acting IL-1 beta program, is expected to enter clinical testing in the first quarter of 2025. The company also referenced life-cycle management strategies inspired by the extended-dosing models of Soliris and Ultomiris.
