On August 19, 2022 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, reported preliminary results from the third cohort of the Company’s first-in-human Phase 1a study of WP1122 (Press release, Moleculin, AUG 19, 2022, View Source [SID1234618507]). 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."

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, 32 and now to 64 mg/kg as single doses) in subsequent cohorts. 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.

For more information about the study, please visit clinicaltrials.gov and reference identifier NCT05195723. Moleculin is also in the process of identifying additional countries where potential future Phase 2 COVID-19 clinical studies could occur and is also in discussions with potential investigators interested in the possible study of WP1122 in other viruses and cancer indications.

About WP1122

WP1122 was developed as a 2-DG prodrug to provide a more favorable pharmacological profile and was found to have greater potency than 2-DG alone in preclinical models where tumor cells require higher glycolytic activity than normal cells. WP1122 has also been shown to have a greater antiviral effect than 2-DG against SARS-CoV-2 in MRC-5 cells in culture. The improved pharmacokinetic and pharmacodynamic (PK/PD) profile of WP1122 compared to 2-DG was noted in female mice following oral dosing at equimolar (i.e., equivalent levels of 2-DG) doses.

While the Company is in the process of identifying additional countries where potential future Phase 2 COVID-19 clinical studies might occur, the volatility and unpredictability of COVID-19 incidence in various countries may limit the ability to recruit certain subjects and could make it infeasible to conduct a Phase 2 clinical trial in a given country. Additionally, Moleculin recently received IND clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 study of WP1122 for the treatment of Glioblastoma Multiforme (GBM). The Company is seeking collaborators with the intent to commence clinical trials of WP1122 in other viruses and cancer indications including GBM, pancreatic cancer and others.