Akebia Acquires Rare Kidney Drug AKB-097 for $7M
Akebia Therapeutics (AKBA) announced the establishment of its rare kidney disease pipeline. The pipeline is comprised of two core product candidates: ADX-097, a potential next generation complement inhibitor, now referred to as AKB-097, and praliciguat, a soluble guanylate cyclase stimulator. Akebia acquired all rights to AKB-097, a tissue-targeted C3d-Factor H fusion protein complement inhibitor, from Q32 Bio Inc. (QTTB) and believes AKB-097 has applicability across a wide range of complement-mediated rare kidney diseases. AKB-097 is targeted to the sites of complement activation in tissues and is not expected to result in systemic complement inhibition seen with other inhibitors. On November 28, 2025, Akebia and Q32 Bio signed an Asset Purchase Agreement under which Akebia acquired global rights to Q32 Bio's ADX-097. In consideration, Akebia paid Q32 Bio an upfront payment of $7M. Akebia will also make a $3M payment upon the six-month anniversary of the closing, as well as additional development and regulatory milestones, commercial milestones and tiered royalties on annual net sales of AKB-097.
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Akebia Doses First Patient in Phase 2 Trial of Praliciguat for FSGS
- Trial Initiation: Akebia Therapeutics has announced the dosing of the first patient in the Phase 2 clinical trial of Praliciguat, its lead drug candidate for FSGS, potentially addressing the needs of approximately 40,000 patients in the U.S. without approved treatments.
- Study Design: This randomized, double-blind, placebo-controlled multicenter study aims to evaluate the efficacy and safety of Praliciguat in reducing the risk of kidney failure, primarily monitoring changes in the urine protein-to-creatinine ratio, which is critical for clinical outcomes.
- Patient Recruitment: Approximately 60 patients will be randomized to receive either Praliciguat or placebo for a 24-week treatment period, after which all participants will transition to an open-label extension to further assess the drug's long-term effects.
- Product Portfolio: Akebia is also advancing other candidates like Vafseo, currently in Phase III development, and AKB-9090 for treating acute kidney injury, indicating a robust pipeline in the renal disease sector.

Akebia Doses First Patient in Phase 2 Trial of Praliciguat for FSGS
- Trial Initiation: Akebia Therapeutics has successfully dosed the first patient in its Phase 2 clinical trial for praliciguat targeting FSGS, marking a significant advancement in the treatment of rare kidney diseases.
- Patient Enrollment and Design: The trial aims to enroll approximately 60 patients, who will be randomized to receive either praliciguat or placebo for an initial 24-week treatment period, designed to evaluate the drug's efficacy and safety.
- Market Demand: FSGS affects around 40,000 patients in the U.S. with no approved treatments available, and the development of praliciguat is poised to fill this market gap, addressing urgent patient needs.
- Safety Profile: Previous Phase 1 and Phase 2 studies have shown praliciguat to have a favorable safety profile with no significant adverse events reported, establishing a solid foundation for its application in rare kidney disease treatment.









