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Flare Therapeutics Announces First Patients Dosed in First-in-Human Phase 1 Clinical Study of FX-909 in Advanced Solid Malignancies, Including Urothelial Cancer

FX-909 is a first-in-class small molecule inhibitor of the PPARG transcription factor for the potential treatment of advanced urothelial carcinoma

Excerpt from the Press Release:

CAMBRIDGE, Mass., Oct. 19, 2023 /PRNewswire/ — Flare Therapeutics Inc., a biotechnology company targeting transcription factors (TF) to discover precision medicines for cancer and other diseases, today announced that the first patients have been dosed in the company’s phase 1 study to assess the safety and tolerability of FX-909, a first-in-class small molecule inhibitor of peroxisome proliferator-activated receptor gamma (PPARG), a master regulator of the luminal lineage. FX-909 is a highly potent and selective inhibitor of PPARG and has demonstrated tumor eradication in preclinical animal models of urothelial cancer at low oral doses.

“We are excited to announce the dosing of patients in the first dose cohort of our Phase 1 clinical study of FX-909, marking a major milestone for Flare Therapeutics as we transition to a clinical stage company,” said Michael L. Meyers, M.D., Ph.D., Chief Medical Officer of Flare Therapeutics. “Rooted in innovation and expertise in transcription factors, FX-909 has the potential to become a backbone therapy for advanced urothelial cancer. We believe PPARG’s role as a master regulator of the luminal lineage may represent a differentiated therapeutic option in advanced urothelial cancer, and we are excited to explore this novel mechanism in the clinic.”

About FX-909

Flare Therapeutics’ lead investigational compound, FX-909, is a first-in-class novel, highly potent and selective small molecule that inhibits the transcription factor peroxisome proliferator-activated receptor gamma (PPARG) to treat patients with the luminal subtype of advanced urothelial carcinoma (UC) and potentially other solid tumors.

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