ADX-097 / Q32 Bio, Akebia Therap - LARVOL DELTA

Q32 Bio Inc…announced that it has sold its Phase 2 complement inhibitor, ADX-097, to Akebia Therapeutics, Inc. (PRNewswire) - "Q32 Bio now expects its cash and cash equivalents, together with the upfront payments and near-term milestone from the sale of ADX-097, to fund operations into the second half of 2027, through the SIGNAL-AA Part A OLE and topline results of the SIGNAL-AA Part B trial expected in mid-2026."

Commercial • P2a data • Alopecia • Immunology • Lupus

ADX-097-201: A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Q32 Bio Inc. | N=30 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Glomerulonephritis • IgA Nephropathy • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease

Q32 Bio Announces Strategic Restructuring to Focus on Advancement of Bempikibart in Patients with Alopecia Areata (PRNewswire) - "As part of the restructuring, the Company is discontinuing the Phase 2 renal basket clinical trial of ADX-097 and is evaluating strategic options for its tissue-targeted complement inhibitor platform, inclusive of ADX-097 and early-stage assets. In combination with other cost-saving measures including a reduction in personnel and related expenses, the strategic restructuring is expected to extend cash runway to the second half of 2026."

Commercial • Trial termination • IgA Nephropathy • Lupus Nephritis

ADX-097-201: A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants with IgAN, LN or C3G (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Q32 Bio Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Enrollment open • Trial completion date • Trial primary completion date • Glomerulonephritis • IgA Nephropathy • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease

ADX-097, a Tissue-Targeted Complement Inhibitor for the Treatment of Kidney Diseases: Phase 1 Results in Healthy Participants and Model-Informed Phase 2 Dose Selection (KIDNEY WEEK 2024) - "ADX-097 demonstrated a favorable safety profile and desired PK/PD properties in healthy participants, supporting a Phase 2 dose that is predicted to provide tissue inhibition of complement in glomerular diseases while sparing systemic complement activity."

Clinical • P1 data • P2 data • Glomerulonephritis • IgA Nephropathy • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease

Q32 Bio to Present Tissue-Targeted Complement Inhibitor ADX-097 Positive Phase 1 Clinical Trial Results at the American Society of Nephrology Kidney Week 2024 (PRNewswire) - "Poster presentation to highlight data from completed first-in-human, Phase 1 ascending dose clinical trial of ADX-097 in healthy volunteers; results support Phase 2 dose selection and continued clinical advancement of ADX-097....Q32 Bio Inc....today announced that it will present clinical data supporting its program for innate immunity, ADX-097, at the American Society of Nephrology (ASN) Kidney Week 2024, taking place October 24-27, 2024, in San Diego, Calif....'In our Phase 1 clinical trial, ADX-097 was observed to be generally well-tolerated with desirable pharmacokinetics and pharmacodynamics (PK/PD) properties. We believe ADX-097 has the potential to achieve relevant complement inhibition directly in the tissue while sparing systemic activity'...Q32 Bio is currently evaluating ADX-097 in an open-label Phase 2 renal basket clinical trial and is planning to evaluate ADX-097 in a Phase 2 clinical trial in ANCA-Associated Vasculitis (AAV)."

P1 data • Trial status • ANCA Vasculitis • Renal Disease

A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Q32 Bio Inc.

New P2 trial • Glomerulonephritis • IgA Nephropathy • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease