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- Akebia Therapeutics has dosed the first patient in an open-label Phase 2 basket trial of ebribafusp in IgA nephropathy, lupus nephritis and C3 glomerulopathy. - The trial will enroll up to 30 patients who receive once-weekly subcutaneous ebribafusp for 26 weeks, followed by a long-term extension for responders. - The primary endpoint is adverse event incidence, with secondary endpoints including proteinuria by UPCR, kidney function by eGFR and pharmacokinetics. - Ebribafusp is an anti-C3d factor H fusion protein designed to inhibit complement activation in kidney tissue without suppressing complement in the blood, with initial data expected in 2027.
- Akebia Therapeutics has dosed the first patient in an open-label Phase 2 basket trial of ebribafusp in IgA nephropathy, lupus nephritis and C3 glomerulopathy. - Ebribafusp is an anti-C3d factor H fusion protein designed to inhibit complement activation in kidney tissue without suppressing the complement system in the blood. - The trial will enroll up to 30 patients receiving once-weekly subcutaneous dosing for 26 weeks, with initial data expected in 2027. - Akebia acquired global rights to ebribafusp from Q32 Bio in November 2025, following nonclinical studies and a completed Phase 1 trial in healthy volunteers.
- Q32 Bio completed enrollment of 33 patients in Part B of the SIGNAL-AA Phase 2a trial evaluating bempikibart for severe alopecia areata, with 36-week topline data expected in mid-2026. - The company achieved steady-state drug concentrations nine weeks earlier than in Part A due to an optimized loading regimen, potentially enabling earlier clinical responsiveness. - Q32 Bio secured financial runway through Q4 2027 via a $10.5 million registered direct offering and the strategic sale of ADX-097 to Akebia Therapeutics for $12 million upfront. - The FDA granted Fast Track designation for bempikibart in alopecia areata to expedite development and regulatory review processes.
- Akebia Therapeutics acquired AKB-097, a tissue-targeted complement inhibitor from Q32 Bio for $7 million upfront, designed to address multiple rare kidney diseases without systemic complement inhibition. - The company initiated a Phase 2 trial of praliciguat, an oral sGC stimulator, in focal segmental glomerulosclerosis (FSGS), targeting up to 60 patients with primary endpoint of proteinuria reduction. - Both therapeutic programs are planned to begin patient enrollment in 2026, with AKB-097 Phase 2 basket trial data expected in 2027. - FSGS affects approximately 40,000 people in the U.S. with no specific treatments currently available, representing a significant unmet medical need.
- DelveInsight's 2025 pipeline report reveals over 35 companies are actively developing more than 40 investigational therapies for lupus nephritis treatment. - Hoffmann-La Roche leads with obinutuzumab in Phase III trials, while other promising candidates include ADX-097 from Q32 Bio and NKX019 from Nkarta Therapeutics. - The FDA granted Fast Track designation to AlloNK from Artiva Biotherapeutics in February 2024 for combination therapy with rituximab or obinutuzumab. - Lupus nephritis affects patients with systemic lupus erythematosus and can progress to chronic kidney disease or end-stage renal disease without effective treatment.
- Q32 Bio appointed Adrien Sipos, M.D., Ph.D., as Interim Chief Medical Officer to oversee the ongoing SIGNAL-AA Phase 2a clinical trial of bempikibart for alopecia areata treatment. - Dr. Sipos brings over 25 years of immunology and inflammation drug development experience from leadership roles at Biogen, Sanofi Genzyme, and Eli Lilly. - The company expects topline results from Part B of the SIGNAL-AA Phase 2a trial in the first half of 2026 for their novel anti-IL-7Rα antibody therapy. - Bempikibart represents a novel therapeutic approach targeting IL-7 and TSLP signaling pathways to treat alopecia areata, which affects approximately 700,000 Americans.
- Oxford BioMedica completed acquisition of the remaining 10% stake in its US subsidiary from Q32 Bio, achieving 100% ownership of the Bedford, Massachusetts facility. - The 96,000 square foot facility offers both lentiviral and AAV vector manufacturing capabilities and has successfully integrated OXB's lentiviral platform in 2024. - The acquisition strengthens OXB's position in the expanding viral vector manufacturing market and supports global client access to cell and gene therapy development services.
- Q32 Bio announces strategic restructuring to focus on bempikibart development for alopecia areata, discontinuing its ADX-097 renal trials to extend cash runway through 2026. - Promising SIGNAL-AA Part A trial data shows sustained SALT score improvements and potential remittive effects for bempikibart, with continued patient response up to 55 weeks post-treatment. - Company plans to initiate an open-label extension study and SIGNAL-AA Part B trial in first half of 2025, with topline data expected in first half of 2026.
• Q32 Bio has postponed the Phase 2 clinical trial of ADX-097 for ANCA-associated vasculitis (AAV), initially expected to begin in 2025, without providing a new timeline. • The company is prioritizing clinical trials for bempikibart in alopecia areata and a basket study of ADX-097 in autoimmune-related kidney damage. • ADX-097, a complement-targeting antibody, aims to selectively inhibit the overactive complement system in affected tissues, based on promising Phase 1 results. • The Phase 1 trial demonstrated ADX-097 was well-tolerated in healthy volunteers, with subcutaneous injections achieving sufficient drug levels to suppress complement activity.
• Q32 Bio's bempikibart showed promise in Phase IIa trial for alopecia areata (AA), achieving a 16% mean reduction in SALT score at week 24 compared to placebo. • However, bempikibart failed its Phase IIa trial for atopic dermatitis (AD), with placebo showing slightly better improvement in EASI scores, leading to investor selloff. • BioAge Labs halted its Phase II STRIDES trial of azelaprag due to liver transaminitis, causing stock downgrade and concerns about the drug's safety profile at higher doses. • Candel Therapeutics and uniQure saw stock surges following positive trial results and FDA agreement, respectively, while CervoMed and Chimerix also experienced significant stock movements.
