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 third cohort of the Company’s first-in-human Phase 1a study of WP1122. This cohort consisted of 10 subjects dosed with 32 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 3, the Safety Review Committee (SRC) for the study deemed the third single ascending dose (SAD) cohort dose safe and well-tolerated, allowing the Company to begin its fourth SAD Cohort with a dose escalation to 64 mg/kg. Additionally, dosing of WP1122 in the multiple ascending dose (MAD) cohorts will commence at a total daily dose of 32 mg/kg, which has been shown to be safe in the single dose cohort.
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The Phase 1a, first-in-human, randomized, double-blind, placebo-controlled, overlapping SAD and MAD study is investigating the effects of WP1122 administered as an oral solution in healthy human volunteers. It is the first step in a potential investigation of WP1122 for the treatment of COVID-19. Furthering such an investigation is dependent upon the volatility and unpredictability of COVID-19 incidence in various countries and the ability to recruit patients for a feasible study.
Dose escalation is taking place in sequential SAD cohorts, and MAD will now begin as 3 SAD have been successfully completed. This study in healthy volunteers is exploring safety and PK, and possible subsequent antiviral clinical development is intended 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 Phase 1 trial.
Walter Klemp, Chairman and Chief Executive Officer of Moleculin commented, “WP1122 has continued to demonstrate the favorable safety and tolerability profile we expected. With three SAD cohorts successfully completed, we can begin the MAD phase of the trial and are another step closer to establishing a maximum tolerated dose. Throughout the three completed cohorts, WP1122 has demonstrated no dose escalating stopping criteria, and we are pleased with the progress of WP1122 toward becoming a potential treatment of certain viral diseases and cancers.”