Isofol Medical AB Receives FDA Fast Track Designation for Arfolitixorin in Metastatic Colorectal Cancer

November 24, 2021 /BioValleyBIOON/ --Isofol Medical AB recently announced that the U.S. Food and Drug Administration (FDA) has granted Modufolin (arfolitixorin, [6R]-5,10-methylene tetrahydrofolate, [6R]-MTHF) Fast Track Designation (FTD) for the treatment of metastatic colorectal cancer (mCRC).Arfolitixorin is a novel compound based on folic acid, used to enhance the efficacy of antimetabolite drugs in cancer treatment and reduce their side effects.Isofol Medical AB has signed an exclusive global licensing agreement with Merck KGaA to develop and commercialize arfolitixorin forTumorIndications for Study.

Arfolitixorin is the key active metabolite of the widely used folate drugs leucovorin and levoleucovorin.Calcium folinate and levofolinate must be converted into the active form [6R]-MTHF in the body to take effect, which depends on, for exampleGeneticsSusceptibility, not all patients will trigger this activation.Studies have shown that three-quarters of mCRC patients have insufficient ability to convert folinic acid and levofolinate, and their progression-free survival (PFS) is significantly reduced compared to patients with good conversion ability.

Fast Track Designation (FTD) aims to accelerate the development and expedite the review of drugs for serious conditions, addressing critical areas of significant unmet medical need. A drug candidate granted Fast Track Designation allows pharmaceutical companies to engage with regulatory authorities during the research and development phase.FDAEngage in more frequent interactions, and if eligible after submitting the listing application, qualify for accelerated approval and priority review, as well as be eligible for rolling review.

In the United States, CRC is the second leading cause of cancer death and the third most common type of cancer. In terms of mCRC treatment, there is a significant unmet medical need for new and more effective treatment options.FDAGrant arfolitixorin FTD, based on the drug's potential to address the significant unmet medical needs in mCRC.

As the first and only pure folate metabolic active substance ([6R]-MTHF) that enhances the cytotoxic effects of 5-fluorouracil (5-FU), arfolitixorin is currently being evaluated in a global pivotal Phase 3 AGENT study (NCT03750786). The study is expected to be completed in 2022. Afterward, Isofol plans to submit to the United States.FDAand submit a marketing application to the EU EMA, with the potential for commercialization as early as 2023.

Isofol CEO Ulf Jugnelius stated, "We are very pleased that the FDA has granted Fast Track designation to our lead candidate drug arfolitixorin. This is a strong external recognition of the potential benefits of arfolitixorin in treating mCRC, a devastating disease. Our next clinical milestone is reaching 300 progression-free survival events in the Phase 3 AGENT study, followed by unblinding the data so that we can analyze and present the top-line results in the first half of 2022. The FTD designation will allow us to engage more frequently with...FDACollaborate to optimize the ongoing development plan for arfolitixorin and potentially make it the first new drug to raise the standard of care for mCRC in over 40 years." (Bioon.com)

Source of Original Text:Isofol Medical AB (publ) receives FDA Fast Track Designation for arfolitixorin in advanced colorectal cancer (mCRC)