Moleculin Biotech has reported initial data from the second cohort of its Phase Ia clinical trial of WP1122 in healthy subjects to potentially treat Covid-19.
Developed as a 2-DG prodrug, WP1122 showed to possess enhanced potency compared to 2-DG alone in preclinical models where tumour cells need greater glycolytic activity than normal cells.
The second cohort comprised eight subjects who received 16 mg/kg WP1122 or placebo in the dose-escalation trial.
According to the overall findings from Cohort 2, the dose was found to be safe and well-tolerated.
Subsequently, the company has initiated its single ascending dose (SAD) Cohort 3 with a dose escalation to 32mg/kg of WP1122.
The first-in-human, double-blind, randomised, placebo-controlled, overlapping SAD and multiple ascending doses (MAD) Phase Ia trial is assessing the impact of WP1122 given as an oral solution in healthy participants to treat Covid-19.
Dose escalation will be carried out in sequential SAD cohorts while MAD will commence following SAD completing a minimum of three dosing cohorts.
The trial intends to analyse the safety and pharmacokinetics (PK) of WP1122 in healthy subjects in the UK.
To further evaluate the safety and establish a favourable risk/benefit profile, the antiviral will be analysed in Covid-19 patients.
A total of 80 participants will be enrolled in the trial.
Moleculin Biotech chairman and CEO Walter Klemp said: “We continue to be encouraged by the safety data demonstrated by WP1122 in the SAD portion of our first-in-human Phase Ia study of WP1122.
“With two of the SAD cohorts now completed with promising preliminary results, we are working to enrol and complete Cohort 3 at 32mg/kg in order to proceed to the MAD phase of the trial toward establishing a maximum tolerated dose.”
In June this year, the company reported positive initial data from the first SAD cohort of a Phase Ia trial of WP1122 in the UK to treat Covid-19.