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Moleculin Commences Dosing in Healthy Volunteers in Phase 1a Clinical Trial of WP1122 for the Treatment of COVID-19
– Single ascending dose (SAD) cohort of first-in-human Phase 1a study to evaluate safety and pharmacokinetics of WP1122 and establish maximum tolerated dose –
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"– Single ascending dose (SAD) cohort of first-in-human Phase 1a study to evaluate safety and pharmacokinetics of WP1122 and establish maximum tolerated dose –\n– Multiple ascending dose (MAD) cohort to commence after completion of at least 3 SAD dosing cohorts in which WP1122 is found to be safe and well-tolerated –\nHOUSTON, May 26, 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 the commencement of dosing in its first-in-human Phase 1a study to evaluate the safety and pharmacokinetics (PK) of WP1122 in healthy volunteers for the treatment of COVID-19 (MB-301). WP1122, the Company's lead metabolism/glycosylation inhibitor, is a prodrug of a well-known glucose decoy called 2-deoxy-D-glucose (2-DG).\n\n \n \n \n \n \n \n\n \nWalter Klemp, Chairman and Chief Executive Officer of Moleculin commented, \"We are pleased to commence dosing in the first group of healthy volunteers. Based on the antiviral effect of WP1122 demonstrated in preclinical models, we remain confident that the drug has the potential to meet the critical need for a pan-viral therapy that could address not only COVID-19 and its variants, but other viruses that depend upon glycolysis and glycosylation. With dosing in our SAD cohort for the study underway, we look forward to evaluating the safety and PK of WP1122 as well as establishing a maximum tolerated dose (MTD) in order to drive development forward. Importantly, establishing safety and an MTD in this study not only sets the stage for further antiviral development, but it also facilitates potential Phase 2 clinical trials for cancer indications.\"\nThe Phase 1a, first-in-human, randomized, double-blind, placebo-controlled, overlapping SAD and MAD will investigate the effects of WP1122 administered as an oral solution in healthy human volunteers in the United Kingdom. Dose escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has completed at least 3 dosing cohorts in which WP1122 is found to be safe and well-tolerated. This study in healthy volunteers will explore safety and PK, and subsequent antiviral clinical development will be in patients infected with SARS-CoV-2 to further evaluate...