Moleculin Biotech has received authorisation to begin a Phase Ia clinical trial of its drug, WP1122, in the UK to treat Covid-19.
The approval was obtained from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
A metabolism/glycosylation inhibitor, WP1122 is a prodrug of an antimetabolite, called 2-deoxy-D-glucose (2-DG) currently being developed to block viral replication and disease manifestations in those infected with SARS-CoV-2 virus.
The company also received a favourable opinion from the UK’s London – Riverside Research Ethics Committee to conduct the trial.
The first-in-human study will assess the safety and pharmacokinetics (PK) of WP1122 in healthy subjects as well as establish a favourable risk or benefit profile.
It will be conducted at the Medicines Evaluation Unit in Manchester and is expected to begin in the fourth quarter of this year.
The study will investigate the effects of a single ascending dose (SAD) and multiple days of ascending dose (MAD) of WP1122 which will be administered orally.
Moleculin stated that the dose escalation will occur in sequential SAD cohorts, and MAD will begin after SAD completed at least three dosing cohorts where WP1122 is found to be safe and well-tolerated.
Safety and tolerability are the primary endpoints of the trial, where the frequency of adverse events (AEs), serious AE, treatment-emergent AE, and AEs of special interest will be measured.
The secondary goal of the trial will be the analysis of PK parameters of WP1122 and its three active metabolites.
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 glycoproteins, 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, WP1122 was found to have increased potency than 2-DG alone.