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July 11, 2022

Moleculin reports initial Phase Ia data studying Covid-19 asset

The trial intends to analyse the safety and pharmacokinetics of WP1122 in healthy subjects in the UK.

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.

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