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May 27, 2022

Moleculin initiates subject dosing in Phase Ia Covid-19 treatment trial

The first-in-human trial will enrol nearly 80 participants to analyse WP1122 for treating Covid-19.

Moleculin Biotech has initiated dosing of subjects in its Phase Ia MB-301 clinical trial of WP1122 in healthy volunteers to treat Covid-19. 

A lead metabolism/glycosylation inhibitor of the company, WP1122 is a prodrug of a glucose decoy known as 2-deoxy-D-glucose (2-DG).

The first-in-human, double-blind, placebo-controlled, randomised trial will analyse the safety and pharmacokinetics (PK) of WP1122 given as an oral solution in healthy human subjects in the UK. 

Nearly 80 participants will be enrolled in the overlapping single ascending dose (SAD) and multiple ascending dose (MAD) trial.

Dose escalation will occur in sequential SAD cohorts.

The SAD cohort of the trial will analyse the safety and pharmacokinetics of WP1122 and identify the maximum tolerated dose. 

MAD will begin once SAD has concluded a minimum of three dosing arms, where WP1122 is observed to be safe and well-tolerated. 

Furthermore, the trial will assess antiviral clinical development in Covid-19 patients to further analyse safety and validate a favourable risk/benefit profile. 

In preclinical models, WP1122 demonstrated enhanced potency versus 2-DG alone, where tumour cells needed increased glycolytic activity than normal cells. 

In addition, the therapy was found to have a superior antiviral effect against the SARS-CoV-2 virus in MRC-5 cells in culture, versus 2-DG. 

Moleculin chairman and CEO Walter Klemp said: “Based on the antiviral effect of WP1122 demonstrated in preclinical models, we remain confident that the drug has the potential to meet the critical need for a pan-viral therapy that could address not only Covid-19 and its variants, but other viruses that depend upon glycolysis and glycosylation. 

“With dosing in our SAD cohort for the study underway, we look forward to evaluating the safety and PK of WP1122 as well as establishing a maximum tolerated dose (MTD) in order to drive development forward.”

The latest development comes after UK’s Medicines and Healthcare Products Regulatory Agency approved the company’s amended protocol for Phase Ia trial of WP1122 in healthy subjects to treat Covid-19.

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