On March 17, 2023 FivepHusion is developing Deflexifol, reported that it has optimised all-in-one formulation of the chemotherapeutic agent 5-FU and its biomodulator LV for the treatment of solid tumours (Press release, FivepHusion, JAN 17, 2023, View Source [SID1234629015]). The Deflexifol formulation addresses significant limitations with current treatment, offering a "best in class" therapy by optimising co-administration of 5-FU and LV at a physiological pH to enhance patient treatment via greater safety, tolerability and superior efficacy.
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In December 2022, FivepHusion, together with its global regulatory consultants PharmaLex, engaged with the US Food and Drug Administration (FDA) in a Type C meeting to seek feedback on the company’s proposed clinical development program, CMC and regulatory paths for Deflexifol. The FDA provided constructive feedback on the design of the planned next clinical trial, FP101B, a dose-ranging clinical study designed to confirm the appropriate Deflexifol dose to take forward into a pivotal phase III trial in mCRC patients. The Agency confirmed that Deflexifol can be developed in 1st line metastatic colorectal cancer patients, and that only one successfully conducted phase III trial should be sufficient for registration of Deflexifol. The FDA stated no concerns about the FivepHusion proposed CMC pathway and also confirmed that registration of Deflexifol should be pursued via the 505(b)(2) regulatory path.
FivepHusion Executive Director, Dr Bill Ketelbey said, "The FDA has provided very valuable feedback on the design elements for our future clinical studies. These insights allow FivepHusion to optimise the Deflexifol clinical development program to generate the data set necessary to achieve registration of Deflexifol as an enhanced 5-FU and LV formulation for the treatment of 1st line metastatic colorectal cancer patients."
FivepHusion CEO, Dr Christian Toouli commented, "This strategically important interaction with the FDA has confirmed our understanding of the clinical development, CMC and regulatory paths for Deflexifol. We are delighted that the Agency confirmed their requirement for one successfully conducted phase III trial and that FivepHusion can develop Deflexifol via the accelerated and de-risked 505(b)(2) regulatory path for our chosen patient population."