PTC Therapeutics Reports the Initiation of the Second Stage of the FITE19 Phase 2/3 Clinical Trial Evaluating PTC299 for the Treatment of COVID-19
"Completion of the first stage of the FITE19 trial is an important milestone that triggers the final stage of the trial to begin," said
The Phase 2/3 clinical trial is a randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of PTC299 in patients hospitalized with COVID-19. The study is being completed in two stages: the first stage enrolled a smaller cohort of 40 patients followed by an interim safety analysis before enrolling the larger cohort of approximately 340 participants in the second stage. The primary endpoint of the study is to evaluate the clinical efficacy of PTC299 compared with placebo assessed by time to respiratory improvement in adult individuals hospitalized with COVID-19.
Please visit PTC's PTC299 COVID-19 FITE19 clinical trial recruitment page, here for more information.
PTC299 is an investigational oral small molecule that inhibits the cellular enzyme dihydroorotate dehydrogenase (DHODH). Recently, DHODH has been independently identified as one of the top-three most promising targets for intervention in COVID-19. PTC299 is being evaluated for the potential treatment of patients with COVID-19. With a novel dual-mechanism of action, PTC299 inhibits DHODH activity which leads to a reduction of pyrimidine biosynthesis and SARS-CoV-2 viral replication, and selectively modulates the immune response by attenuating the stress-induced inflammatory cytokine storm. PTC299 has broad-spectrum antiviral activity and potent inhibition of numerous RNA viruses with low nanomolar potency. PTC299 is also currently being evaluated in an ongoing clinical study in acute myeloid leukemia (AML).
PTC is a science-driven, global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders. PTC's ability to globally commercialize products is the foundation that drives investment in a robust pipeline of transformative medicines and our mission to provide access to best-in-class treatments for patients who have an unmet medical need. To learn more about PTC, please visit us on www.ptcbio.com and follow us on Facebook, on Twitter at @PTCBio, and on LinkedIn.
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