Moleculin Biotech has reported preliminary data from the third single ascending dose (SAD) cohort of the Phase Ia clinical trial of 2-DG prodrug, WP1122, to potentially treat Covid-19.
The randomised, double-blind, first-in-human, placebo-controlled, overlapping SAD, and multiple ascending dose (MAD) trial is designed to assess WP1122’s impact as an oral solution in healthy human subjects.
Ten subjects were enrolled in the third cohort of this dose escalation trial and were given 32mg/kg of WP1122 or a placebo.
The safety and pharmacokinetics (PK) of WP1122 in healthy subjects in the UK were analysed.
The third SAD cohort dose was considered to be safe and well-tolerated by the trial’s Safety Review Committee (SRC) based on the overall findings from this cohort.
This will aid Moleculin in commencing the fourth SAD Cohort with a dose escalation to 64mg/kg.
Dosing in the MAD cohorts with the therapy will begin at a total daily dose of 32mg/kg, which was found to be safe in the single dose arm.
On completing this trial in healthy subjects, the company will advance WP1122’s clinical development in Covid-19 patients to assess the safety and validate its favourable risk/benefit profile.
Nearly 80 subjects will be enrolled in this Phase I trial.
Moleculin Biotech chairman and CEO Walter Klemp said: “WP1122 has continued to demonstrate the favourable 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.”
In addition, the company is currently working on selecting additional countries to conduct Phase II Covid-19 trials and holding talks with potential investigators to trial WP1122 for various other viruses and cancer indications.
In July this year, Moleculin reported initial data from the second cohort of its Phase Ia trial of WP1122 in healthy subjects for Covid-19.