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.
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.
Dose escalation of the trial, which is overlapping SAD and a multiple ascending dose (MAD), will take place in sequential SAD cohorts.
MAD 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.