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 second cohort of the Company’s first-in-human Phase 1a study of WP1122. This cohort consisted of 8 subjects dosed with 16 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 2, the Company deemed the cohort dose safe and well-tolerated and began its SAD Cohort 3 with a dose escalation to 32 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 is expected to 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, “We continue to be encouraged by the safety data demonstrated by WP1122 in the SAD portion of our first-in-human Phase 1a study of WP1122. With two of the SAD cohorts now completed with promising preliminary results, we are working to enroll and complete Cohort 3 at 32 mg/kg in order to proceed to the MAD phase of the trial toward establishing a maximum tolerated dose. To date, WP1122 has demonstrated no dose escalating stopping criteria, and we look forward to taking the next step in studying the potential of WP1122 for the treatment of certain viral diseases, including COVID-19, and cancers.”
During the SAD portion of this study, dose escalation will proceed up to a maximum dose of 64 mg/kg as a single dose. Dosing of WP1122 began in SAD at 8 mg/kg as a single dose and has escalated in two-fold increments (i.e., to 16 and now to 32 mg/kg as single doses, etc.) in subsequent cohorts. Dosing of WP1122 in the MAD cohorts will start after a dose of 32 mg/kg has been shown to be safe in the single dose cohort. The first dose administered in MAD will be 16 mg/kg every 12 hours (32 mg/kg/day) for 7 days and dosing in the second MAD cohort will escalate to 32 mg/kg every 12 hours (64 mg/kg/day) for 7 days.