FX-909

Flare Therapeutics’ lead asset, FX-909, is a first-in-class orally available small molecule inhibitor of PPARG, the master regulator of the luminal lineage, currently undergoing a Phase 1 study in patients with locally advanced or metastatic urothelial cancer.

FX-909 is currently being evaluated in a randomized Phase 1B study evaluating safety and efficacy in second line or beyond to determine the recommended Phase 2 dose in a biomarker-defined PPARGhigh locally advanced (unresectable) or metastatic UC patient population. Additional information on this clinical trial can be found on www.clinicaltrials.gov (NCT05929235).

About Advanced Urothelial Cancer

Advanced urothelial cancer (UC) is an aggressive and challenging form of bladder cancer, representing approximately 25% of all bladder cancers diagnosed each year. In the United States, bladder cancer accounts for approximately 84,000 new cases each year, with urothelial carcinoma being the predominant histologic type. In advanced or metastatic stages, the disease is notably difficult to treat, with over 50% of patients experiencing disease progression within six to nine months of first-line chemotherapy. The five-year survival rate for metastatic UC remains poor, with estimates below 6%.

While the introduction of checkpoint inhibitors and targeted therapies has expanded treatment options, clinical outcomes remain suboptimal, underscoring an urgent need for additional and more effective treatment options.

Molecular subtyping has revealed that luminal tumors, comprise approximately 65% of advanced urothelial cancers and express high levels of PPARG. These luminal tumors are characterized by activation of the PPARG pathway, which plays a critical role in maintaining tumor identity, promoting tumor growth, and contributing to immune evasion. It is estimated that in the United States alone, there are approximately 14,000 new cases of advanced urothelial cancer with high PPARG expression diagnosed each year, based on the portion of luminal subtypes and overall incidence data.

FREQUENTLY ASKED QUESTIONS

What is FX-909?
FX-909 is a novel, first-in-class small molecule that inhibits the transcription factor peroxisome proliferator-activated receptor gamma (PPARG). Discovered and developed by Flare Therapeutics, FX-909 is being tested in a Phase 1B study in patients with locally advanced (unresectable) or metastatic urothelial cancer with high expression of PPARG.
What exactly is PPARG?
PPARG is a type of protein known as a transcription factor, which plays a significant role in regulating gene expression and various biological processes in the body. It is a nuclear receptor that binds to specific DNA sequences and influences the expression of genes. High PPARG expression defines the cell identity of luminal bladder cancer and is the top survival gene identified in this cancer subtype.
How does FX-909 work as a treatment for bladder cancer?
Treatments that target and inhibit transcription factors have been backbone therapies in cancer for decades. The transcription factor PPARG was found to be over-expressed and/or genetically altered in the luminal subtype of advanced urothelial cancer, highlighting its potential as a target for treatment.
What is the main goal of the FX-909 Phase 1B clinical study?
The primary goals of the clinical study are to evaluate the safety, tolerability and efficacy of FX-909 and to select a recommended Phase 2 dose in a biomarker-defined population of patients who express high levels of PPARG.
Are you currently enrolling in the FX-909 clinical study?
Yes, we are currently enrolling patients in the Phase 1B study of FX-909.
How can I learn more about the clinical study and eligibility to participate?
To learn more about the FX-909 study, sponsored by Flare Therapeutics, and eligibility criteria for participation, please visit the official clinical study page at https://clinicaltrials.gov/study/NCT05929235.
Who can I contact at Flare Therapeutics for more information about FX-909 or the clinical study?
For further general inquiries, you can contact Flare Therapeutics at clinops@flaretx.com. You can also consult with your doctor.
How is the drug administered?
In the clinical study, FX-909 will be given initially orally once daily in 28-day cycles.
Have patients been treated with FX-909?
Yes, 36 advanced UC patients were enrolled in the Phase 1A study and clinical proof-of-concept was established in patients with advanced UC whose tumors express high levels of PPARG. Enrollment is now ongoing in the Phase 1B expansion study.
What is the anticipated timeline for the Phase 1 study of FX-909?
The Phase 1 study consists of two parts: (1) the dose escalation phase which has achieved clinical proof-of-concept as a monotherapy, and (2) the dose-expansion phase which is now actively enrolling patients.
How can we stay updated on the progress of FX-909 and the clinical study?
Please refer to the Flare Therapeutics’ News section or clinicaltrials.gov for the latest updates on FX-909.

COMPASSIONATE USE POLICY

Compassionate use, also called expanded access, refers to a pathway in which patients with serious or immediately life-threatening diseases may gain access to an investigational therapy outside the context of participation in clinical trials. At this time, Flare Therapeutics does not have an expanded access program that allows patients to have access to our investigational products prior to FDA approval.

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