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Moleculin Receives Authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) to Commence Phase 1a Clinical Trial of WP1122 for the Treatment of COVID-19
- First-in-human Phase 1a study to evaluate safety and pharmacokinetics of WP1122 in healthy volunteers and establish maximum tolerated dose expected to
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"- First-in-human Phase 1a study to evaluate safety and pharmacokinetics of WP1122 in healthy volunteers and establish maximum tolerated dose expected to commence in 4th Quarter 2021 -\n - Based on previously announced preclinical data demonstrating its antiviral potential, the Company believes WP1122 may potentially help meet the critical need for a pan-viral therapy that could address not only COVID-19 and its variants, but also future viruses -\n\n\nHOUSTON, Oct. 19, 2021 /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 it has received authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) to commence a Phase 1a clinical trial of WP1122 in the United Kingdom. WP1122, the Company's lead metabolism/glycosylation inhibitor, is a prodrug of a well-known antimetabolite 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 Company also announced it has received a favorable opinion from the London - Riverside Research Ethics Committee in the UK to begin the study, which is expected to be conducted at the Medicines Evaluation Unit in Manchester, United Kingdom.\n\n \n \n \n \n \n \n\n \n\"We are incredibly grateful for the ongoing efforts and discussions the MHRA has engaged in with us to advance this important program. Coronaviruses, including SARS-CoV-2, are highly dependent upon glycosylation to form structurally and functionally different essential glycoproteins, as well as glycolysis for energy production. The potent antiviral effect demonstrated by WP1122 in preclinical models to-date is encouraging and bolsters our belief in its potential as an effective therapy for COVID-19,\" commented Walter Klemp, Chairman and CEO of Moleculin.\nThe Phase 1a study in healthy human volunteers will investigate the effects of a single ascending dose (SAD) and multiple days of ascending dosing (MAD) of WP1122 administered as an oral solution. 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 ...