Akebia Therapeutics Announces First Patient Dosed in Phase 2 Basket Trial of Ebribafusp in Rare Complement-Mediated Kidney Diseases
Akebia Therapeutics (AKBA) has dosed the first patient in an open-label Phase 2 basket trial of investigational drug ebribafusp for rare complement-mediated kidney diseases.
Rhea-AI Summary
Akebia Therapeutics (AKBA) has dosed the first patient in an open-label Phase 2 basket trial of investigational drug ebribafusp for rare complement-mediated kidney diseases.
The study evaluates patients with IgA nephropathy, lupus nephritis and C3 glomerulopathy and is expected to enroll up to 30 participants. Ebribafusp, a next-generation anti-C3d factor H fusion protein, is designed to inhibit complement activation in kidney tissue without blocking the complement system in blood. Patients will receive once-weekly subcutaneous dosing for 26 weeks, followed by a long-term extension for responders, with initial data expected in 2027.
The primary endpoint is incidence of adverse events, and secondary endpoints include changes in proteinuria (UPCR), kidney function (eGFR) and pharmacokinetics, along with blood and urine complement biomarkers.
Positive
- Phase 2 basket trial initiated with first patient dosed and up to 30 patients planned across IgAN, LN and C3G.
- Defined dosing regimen of once-weekly subcutaneous ebribafusp for 26 weeks plus a long-term extension for responders.
- Initial Phase 2 data expected in 2027, giving a disclosed timeline for upcoming clinical readouts.
- Prior Phase 1 experience in healthy volunteers showed ebribafusp was generally well-tolerated with minimal anti-drug antibodies.
- Global rights to ebribafusp were acquired from Q32 Bio in November 2025, consolidating development control.
Negative
- None.
News Explained
Akebia reports that it acquired global rights to ebribafusp from Q32 Bio in November 2025; the release provides no consideration or ownership terms, so it establishes Akebia’s rights to the program without quantifying any financing or dilution effect for existing holders.
Details
Market Reaction – AKBA
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Key Figures
- Initial data timing
- 2027
- Phase 2 ebribafusp basket trial
- Planned enrollment
- up to 30 patients
- Phase 2 basket trial
- Main study duration
- 26 weeks
- Once-weekly subcutaneous dosing
Previous Clinical trial Reports
-
Earlier announcement initiated same ebribafusp basket trial; 24-hour reaction was negative.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
pharmacokinetics medical
IgA nephropathy medical
lupus nephritis medical
C3 glomerulopathy medical
UPCR medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Open-label Phase 2 trial evaluating ebribafusp for the treatment of IgA nephropathy, lupus nephritis and C3 glomerulopathy
Initial data is expected in 2027
WALTHAM, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the first patient has been dosed in its Phase 2 basket trial evaluating ebribafusp for the treatment of rare complement-mediated kidney diseases, including IgA nephropathy (IgAN), lupus nephritis (LN), and C3 glomerulopathy (C3G). Ebribafusp is an investigational, next-generation anti-C3d factor H fusion protein designed to inhibit complement activation in tissues without inhibiting the complement system in the blood. The Phase 2 basket trial is open-label, and Akebia expects to report initial data in 2027.
“Dosing the first patient in this basket trial is an important milestone for the ebribafusp program and, more importantly, for patients living with rare kidney diseases,” said Dr. Steven Burke, Chief R&D and Medical Officer at Akebia. “Ebribafusp is designed to inhibit complement activation directly in kidney tissue without suppressing the complement system in the blood. If successful, we believe this differentiated approach has the potential to provide patients with a long-term treatment option while reducing the infection risk associated with systemic complement inhibition and could have applicability across multiple rare kidney diseases.”
The Phase 2 basket trial is designed to evaluate the safety, efficacy, and pharmacokinetics of ebribafusp and is expected to enroll up to 30 patients with IgAN, LN or C3G. Patients will receive ebribafusp dosed once-weekly subcutaneously for 26 weeks in the main study followed by a long-term extension study for responders. The primary endpoint is the incidence of adverse events, and secondary endpoints include change in proteinuria measured by urine protein creatinine ratio (UPCR), kidney function measured by estimated glomerular filtration rate (eGFR), and pharmacokinetics. The trial will also measure blood and urine complement biomarkers to assess the extent that ebribafusp reduces complement activity in kidney tissue without inhibiting the complement system in the blood.
Additional information about the trial is available at ClinicalTrials.gov under identifier NCT06419205.
About Ebribafusp
Ebribafusp (previously referred to as AKB-097 and ADX-097), an anti-C3d factor H fusion protein, is an investigational, next-generation complement inhibitor. The presence of C3d in glomeruli is a hallmark of numerous complement-mediated kidney diseases. Ebribafusp is designed to target the sites of complement activation in tissues to inactivate the alternative pathway C3 convertase. Ebribafusp is being studied with the goal of targeting local, uncontrolled complement activity and inflammation at the site of kidney injury.
In November 2025, Akebia acquired the global rights to ebribafusp from Q32 Bio, Inc. (Q32 Bio). In nonclinical studies conducted by Q32 Bio, ebribafusp distributed to affected tissues and organs and demonstrated durable tissue pharmacokinetic and pharmacodynamic properties. In a completed Phase 1 clinical trial in healthy volunteers conducted by Q32 Bio, ebribafusp was observed to be generally well-tolerated and demonstrated minimal anti-drug antibodies.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Waltham, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.
Forward-Looking Statements
Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to: Akebia’s beliefs and expectations regarding the potential benefits and mechanism of action of ebribafusp, including its potential to inhibit complement activation directly in kidney tissue without suppressing the complement system in the blood, its ability to target the sites of complement activation in tissues to inactivate the alternative pathway C3 convertase, and its ability to target local, uncontrolled complement activity and inflammation at the site of kidney injury; Akebia’s beliefs that ebribafusp represents a differentiated approach that, if successful, has the potential to provide patients with a long-term treatment option while reducing the infection risk associated with systemic complement inhibition; Akebia’s beliefs that ebribafusp could have applicability across multiple rare kidney diseases; Akebia’s beliefs and expectation regarding the initiation of the Phase 2 basket trial, including the potential benefit for patients living with rare kidney diseases; and Akebia’s goals and expectations regarding the Phase 2 basket trial, including its ability to demonstrate safety, efficacy and pharmacokinetics, the number of patients to be enrolled and the timing of reporting initial data from the trial.
The terms "intend," "believe," "plan," "goal," "potential," "anticipate,” "estimate," “target,” “predict,” "expect," "future," “may,” "will," “could,” "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: the potential therapeutic benefits, safety profile, and effectiveness of Akebia’s products and product candidates; risks and uncertainties related to Akebia’s ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials, the ability to enroll patients in and the timing of such preclinical studies and clinical trials; the results of Akebia’s preclinical studies and clinical trials, including that initial, preliminary, interim or retrospective data, analysis or results may not be replicated in, or predictive of, final analyses or results of future preclinical or clinical data, analyses or results or that such analysis or results may not support further development of such product candidates; decisions made by health authorities, such as the FDA, with respect to regulatory filings and other interactions; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to Akebia’s commercial products, including estimates regarding the potential market opportunity; the competitive landscape for Akebia’s commercial products, including generic entrants and the timing thereof; Akebia’s ability to obtain and maintain patent protection on its products and product candidates, and to successfully defend these patents against third-party challenges; Akebia’s ability to attract and retain qualified personnel; Akebia's ability to achieve and maintain profitability and to maintain operating expenses consistent with its operating plan; Akebia’s revenue and that its financial results from prior periods may not be indicative of future results; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; early termination of any of Akebia's collaborations; and changes in the geopolitical environment and uncertainty surrounding U.S. trade policy on tariffs. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC), and other filings that Akebia may make with the SEC in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.
Akebia Therapeutics® is a registered trademark of Akebia Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
Which diseases are included in Akebia’s Phase 2 basket trial of ebribafusp?
The Phase 2 basket trial includes patients with IgA nephropathy (IgAN), lupus nephritis (LN) and C3 glomerulopathy (C3G), all described as rare complement-mediated kidney diseases.
How is ebribafusp administered and for how long in this Phase 2 study?
Patients in the main Phase 2 study receive once-weekly subcutaneous injections of ebribafusp for 26 weeks, followed by a long-term extension study for those who are classified as responders.
What are the primary and secondary endpoints of the ebribafusp Phase 2 trial?
The primary endpoint is the incidence of adverse events. Secondary endpoints include change in proteinuria measured by urine protein creatinine ratio (UPCR), kidney function measured by estimated glomerular filtration rate (eGFR) and pharmacokinetics. The trial will also measure blood and urine complement biomarkers to evaluate how ebribafusp affects complement activity in kidney tissue without inhibiting complement in the blood.
What is ebribafusp’s mechanism of action as described by Akebia?
Ebribafusp is described as an anti-C3d factor H fusion protein designed to target sites of complement activation in tissues and inactivate the alternative pathway C3 convertase. The company said it aims to inhibit complement activation directly in kidney tissue while avoiding suppression of the complement system in the blood.
Where can more detailed information about the ebribafusp Phase 2 trial be found?
Additional information about the Phase 2 basket trial of ebribafusp is available on ClinicalTrials.gov under identifier NCT06419205.