Moleculin Biotech, Inc., a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported preliminary results from the first cohort of the Company’s first-in-human Phase 1a study of WP1122. This cohort consisted of 9 subjects dosed with 8 mg/kg or placebo in the dose escalation trial evaluating the safety and pharmacokinetics (PK) of WP1122 in healthy volunteers in the United Kingdom (UK). Based on the overall results in Cohort 1, the Company deemed the first cohort dose safe and well-tolerated and will open SAD Cohort 2 with a dose escalation to 16 mg/kg.
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The Phase 1a, first-in-human, randomized, double-blind, placebo-controlled, overlapping SAD and MAD is investigating the effects of WP1122 administered as an oral solution in healthy human volunteers. It is the first step in a planned investigation of WP1122 for the treatment of COVID-19. Dose escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has successfully completed at least 3 dosing cohorts. 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 safety and establish a favorable risk/benefit profile. The Company expects to enroll approximately 80 subjects in this trial.
Walter Klemp, Chairman and Chief Executive Officer of Moleculin commented, “While still very early in our first-in-human Phase 1a study of WP1122, we are encouraged by the preliminary safety data demonstrated by WP1122. With this Cohort now complete and no dose escalating stopping criteria seen to date, we are actively working to enroll healthy volunteers in Cohort 2 at 16 mg/kg and advance toward establishing a maximum tolerated dose. Setting an MTD for WP1122 is key to having potential future Phase 2 WP1122 clinical studies for the treatment of certain viruses, including COVID-19, and cancers.”