Akebia Therapeutics Announces First Patient Dosed in Phase 2 Clinical Trial of Praliciguat for the Treatment of Focal Segmental Glomerulosclerosis (FSGS)

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BullishLong TermResearch AnalysisCYCN

High Materiality8/10

Information

CAMBRIDGE, Mass., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a b...

AI Summary

Akebia Therapeutics (AKBA) has initiated a Phase 2 clinical trial of praliciguat, targeting FSGS, a rare kidney disease affecting 40,000 patients in the U.S. The drug has shown a promising safety profile in earlier studies, and the trial aims to measure efficacy through changes in urine protein-to-creatinine ratio.

Trading Thesis

Investors may consider AKBA positively due to the potential breakthrough treatment for unmet medical needs.

Market-Moving

Positive trial outcomes could significantly boost AKBA's stock price.
FSGS affects a notable patient base, indicating market potential.
Praliciguat showing no safety issues builds investor confidence.
The lack of approved treatments heightens demand for solutions.
Success in this trial could attract acquisition interest.

Key Facts

Praliciguat is an sGC stimulator being evaluated for FSGS.
Study involves 60 patients, randomized 1:1 to drug or placebo.
Primary endpoint is urine protein-to-creatinine ratio at Week 24.
FSGS currently has no approved therapies in the U.S.
Akebia is headquartered in Cambridge, Massachusetts.

Companies Mentioned

Cyclerion Therapeutics (CYCN): Licensed praliciguat to Akebia, could influence their collaboration.

Research Analysis

The announcement impacts Akebia's standing in the biopharmaceutical sector by potentially addressing significant patient needs in kidney disease, positioning the company favorably for investors hoping for advancements in rare diseases.

FAQ

Why Bullish?

The initiation of a Phase 2 trial suggests progress in AKBA's drug pipeline, crucial for stock valuation. Successful clinical trial results in an area with no competition could lead to substantial market uptake.

How important is it?

The information is directly related to AKBA’s pipeline and market strategy, increasing its relevance in the context of investment decisions.

Why Long Term?

Clinical trials typically require substantial time to yield results, but successful trials could lead to long-term value appreciation in AKBA's stock, as FSGS treatments gain attention.

Related Companies

CYCN

Akebia Therapeutics Doses First Patient in Phase 2 Trial of Praliciguat for FSGS Treatment

Published on: January 06, 2026 | Source: GlobeNewsWire

Introduction to the Phase 2 Clinical Trial

Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company dedicated to enhancing the lives of individuals affected by kidney disease, has recently announced the successful dosing of the first patient in its Phase 2 clinical trial of praliciguat. This oral, once-daily soluble guanylate cyclase (sGC) stimulator is being evaluated for its efficacy in treating focal segmental glomerulosclerosis (FSGS), a rare kidney disease confirmed via biopsy.

Significance of the Phase 2 Trial

The initiation of this Phase 2 trial is a significant milestone for Akebia, as FSGS affects approximately 40,000 patients in the United States and currently has no approved treatments. Dr. Steven K. Burke, Chief Medical Officer at Akebia, expressed enthusiasm regarding the trial, stating, “We are pleased by the timely initiation of this important Phase 2 clinical trial of praliciguat and have successfully dosed the first patient following the defined screening process.”

Trial Design and Objectives

The Phase 2 study is a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the safety and efficacy of praliciguat in adults diagnosed with biopsy-confirmed FSGS. Key details of the trial include:

Approximately 60 patients will be recruited, all receiving maximally tolerated doses of either an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB).
Participants will be randomized in a 1:1 ratio to receive either praliciguat or a placebo for an initial 24-week treatment period.
After the double-blind phase, all patients will transition to receiving praliciguat in an open-label segment for an additional 24 weeks.

The primary endpoint of this trial is the change from baseline in the urine protein-to-creatinine ratio (UPCR) measured at Week 24, while the secondary endpoint evaluates the percentage of patients achieving partial remission at the same time point.

About Praliciguat

Akebia licensed praliciguat from Cyclerion Therapeutics, Inc. The compound has shown a favorable safety profile, with no significant safety issues observed in earlier Phase 1 studies involving healthy volunteers and Phase 2 studies in patients with heart failure and diabetic kidney disease. Any adverse events related to praliciguat have been infrequent and in line with its known blood pressure lowering effects.

About Akebia Therapeutics

Founded in 2007 and headquartered in Cambridge, Massachusetts, Akebia Therapeutics, Inc. is committed to improving the quality of life for people with kidney disease. The company's focus includes developing innovative therapies for rare kidney diseases as part of its expanding pipeline.

Forward-Looking Statements

In compliance with the U.S. Private Securities Litigation Reform Act of 1995, the statements made herein regarding Akebia’s strategies, plans, and expectations related to the Phase 2 trial of praliciguat are considered forward-looking statements. Actual results may significantly differ due to various risks, including but not limited to regulatory decisions and the potential therapeutic benefits of Akebia’s development candidates.