Flare Therapeutics has dosed the first subjects in its Phase I clinical trial of FX-909 to treat advanced solid malignancies, including urothelial carcinoma.

The first-in-human, dose-escalation and dose-expansion trial is designed to assess the tolerability, safety, pharmacokinetics, pharmacodynamics and clinical activity of the investigational compound.

In the dose-escalation portion (Part A) of the trial, oral once-a-day doses of FX-909 will be administered for 28 days to determine the recommended dose for the Phase II trial. 

The expansion portion (Part B) will further assess the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of the compound in locally advanced (unresectable) or metastatic urothelial carcinoma patients. 

FX-909 is a small molecule peroxisome proliferator-activated receptor gamma (PPARG) inhibitor. Its low oral doses showed strong anti-tumour activity in preclinical urothelial cancer animal models.

Flare Therapeutics chief medical officer Michael Meyers said: “We are excited to announce the dosing of patients in the first dose cohort of our Phase I clinical study of FX-909, marking a major milestone for Flare Therapeutics as we transition to a clinical-stage company. 

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“Rooted in innovation and expertise in transcription factors, FX-909 has the potential to become a backbone therapy for advanced urothelial cancer.”

The company focuses on targeting transcription factors (TFs) to completely realise their therapeutic potential.

The trial initiation comes after Flare secured $123m in a Series B funding round jointly led by GordonMD Global Investments and Pfizer Ventures.

The company utilised this funding capital to advance FX-909 to the clinical trial stage.