Moleculin Biotech has obtained the UK Medicines and Healthcare Products Regulatory Agency (MHRA) authorisation to initiate a Phase Ia clinical trial of its drug, WP1122, in the country to treat Covid-19.
An inhibitor of metabolism/glycosylation, WP1122 is a prodrug of an antimetabolite known as 2-deoxy-D-glucose (2-DG).
The London-Riverside Research Ethics Committee also provided a favourable opinion to commence the trial that is anticipated to be carried out at the Medicines Evaluation Unit in Manchester.
To be launched in the fourth quarter of this year, the Phase Ia trial will evaluate the safety and pharmacokinetics (PK) of WP1122 in healthy subjects.
It will then progress to assess the clinical development in Covid-19 patients to further analyse the safety and establish a favourable risk or benefit profile.
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In addition, the impact of a single ascending dose (SAD) and multiple days of ascending dose (MAD) of the oral dose of WP1122 in healthy subjects, will be investigated.
Dose escalation will occur in sequential SAD arms, while MAD will commence on SAD concluding a minimum of three dosing arms where WP1122 demonstrates to be safe and well-tolerated.
Nearly 80 healthy subjects will be enrolled in the country for the trial.
Safety and tolerability are the trial’s primary goals, which will be measured by the incidence of adverse events (AEs), drug-emergent AEs, serious AEs and AEs of peculiar interest.
In the trial, clinically substantial variations from baseline in clinical lab values, physical analysis, vital signs and electrocardiograms will be recorded.
The analysis of PK parameters of WP1122 and three of its active metabolites will be the secondary goal of the trial.
Moleculin Biotech chairman and CEO Walter Klemp said: “Coronaviruses, including SARS-CoV-2, are highly dependent upon glycosylation to form structurally and functionally different essential ŚĀglycoproteins, as well as glycolysis for energy production.
“The potent antiviral effect demonstrated by WP1122 in preclinical models to date is encouraging and bolsters our belief in its potential as an effective therapy for Covid-19.”
In preclinical models of tumour cells that needed increased glycolytic activity compared to normal cells, WP1122 was demonstrated to have increased potency than 2-DG alone.
Furthermore, WP1122 was found to have a higher antiviral effect versus 2-DG against Covid-19 in MRC-5 cells in culture.
In March last year, Moleculin collaborated with the University of Texas Medical Branch at Galveston to assess its molecular inhibitors, including WP1122, to treat various viruses.