Moleculin Biotech has reported positive initial data from the first single ascending dose (SAD) cohort of a Phase Ia clinical trial of its 2-DG prodrug, WP1122, in the UK to treat Covid-19.
In the dose-escalation first-in-human trial, this cohort comprised nine participants who were given 8mg/kg or placebo analysing the safety and pharmacokinetics (PK) of the prodrug in healthy volunteers.
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Based on the overall results, the first cohort dose was deemed to be safe and well-tolerated.
The company expects to open SAD Cohort 2 with a dose escalation to 16mg/kg for establishing a maximum tolerated dose (MTD).
The Phase Ia, double-blind, placebo-controlled, randomised trial is evaluating WP1122 effects when administered as an oral solution in healthy participants.
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Dose escalation of the trial, which is overlapping SAD and a multiple ascending dose (MAD), will take place in sequential SAD cohorts.
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By GlobalDataMAD will commence after concluding at least three SAD dosing cohorts successfully.
It is said to be the initial step in a planned analysis of WP1122 to treat Covid-19.
Set to be carried out in healthy volunteers, the study will explore safety and PK, and subsequent antiviral clinical development will be in SARS-CoV-2-infected patients for further safety evaluation and establishment of a favourable risk/benefit profile.
A total of around 80 subjects are expected to be enrolled in this trial.
Moleculin Biotech chairman and CEO Walter Klemp said: “With this cohort now complete and no dose-escalating stopping criteria seen to date, we are actively working to enrol healthy volunteers in Cohort 2 at 16mg/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.”
Dose escalation is expected to proceed up to a maximum of 64mg/kg as a single dose, during the trial’s SAD portion.
In this portion, the dosing of WP1122 started at 8mg/kg as a single dose and will escalate in two-fold increments to 16mg/kg and then 32mg/kg in subsequent cohorts.
Following the achievement of a dose of 32mg/kg in this cohort, the prodrug dosing will begin in the MAD cohorts.
In the MAD portion, the first dose administered will be 16mg/kg every 12 hours for a period of seven days.
Dosing in the second MAD cohort will escalate to 32mg/kg every 12 hours for the same number of days.
Last month, Moleculin initiated subject dosing in the Phase Ia MB-301 clinical trial of WP1122 in healthy volunteers to treat Covid-19.
