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Moleculin Receives Approval from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for Protocol Amendment to Phase 1a Clinical Trial of WP1122 for the Treatment of COVID-19
– Dosing for first-in-human Phase 1a study to evaluate safety and pharmacokinetics of WP1122 in healthy volunteers and establish maximum tolerated dose
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"– Dosing for first-in-human Phase 1a study to evaluate safety and pharmacokinetics of WP1122 in healthy volunteers and establish maximum tolerated dose expected to commence imminently –\nHOUSTON, May 10, 2022 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (\"Moleculin\" or the \"Company\"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that it has received approval from the United Kingdom's (UK) MHRA to proceed with a first-in-human Phase 1a study to evaluate the safety and pharmacokinetics of WP1122 in healthy volunteers for the treatment of COVID-19 (MB-301). The approval follows Moleculin's having submitted a protocol amendment allowing for a higher ratio of diluting excipients to drug substance to facilitate a faster and simpler mixing procedure before drug administration.\n\n \n \n \n \n \n \n\n \nWalter Klemp, Chairman and Chief Executive Officer of Moleculin commented, \"Approval of the protocol amendment from the MHRA is another encouraging step forward. We believe the antiviral effect demonstrated by WP1122 in preclinical models to-date suggests that the drug may have the potential to meet the critical need for a pan-viral therapy that could address not only COVID-19 and its variants, but also other viruses that cause human disease. As we are also developing this drug for human cancers, this Phase 1 trial may also provide information that helps advance our cancer research. We remain committed to advancing the development of WP1122 and look forward to the commencement of dosing in healthy volunteers, which we expect later this month.\"\nWP1122, the Company's lead metabolism/glycosylation inhibitor, is a prodrug of a well-known glucose decoy called 2-deoxy-D-glucose (2-DG), currently being developed for inhibition of viral replication and disease manifestations in humans infected with SARS-CoV-2, the virus responsible for COVID-19. The mechanism of action of 2-DG includes both the inhibition of glycolysis and the disruption of glycosylation, two processes that are important to both viral activity and tumor development. WP1122 was developed as a 2-DG prodrug to provide a more favorable pharmacological profile, and was found to have greater potency than 2-DG alone in preclinical models where tumor cells require higher...