The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted approval for Moleculin Biotech’s amended protocol for Phase Ia clinical trial of WP1122 in healthy volunteers to treat Covid-19.

The approval came after the company submitted a protocol amendment allowing for an increased ratio of diluting excipients to drug substance to enable a quicker mixing procedure before administering the drug.

A 2-deoxy-D-glucose (2-DG) prodrug, WP1122 is an inhibitor of metabolism/glycosylation and is claimed to offer a favourable pharmacological profile.

It is being developed for hindering viral replication and manifestations of the disease in Covid-19 patients.

The trial will analyse the safety and pharmacokinetics (PK) of the 2-DG prodrug in healthy subjects.

Later on, the clinical development will advance to Covid-19 patients to further assess the safety and validate a favourable risk/benefit profile. 

The impact of a single ascending dose (SAD) and multiple days of ascending dosing (MAD) of the therapy given as an oral solution will be evaluated. 

Dose escalation will be carried out in consecutive SAD cohorts while MAD will be initiated on SAD concluding a minimum of three cohorts in which WP1122 demonstrates to be safe and well-tolerated. 

The company intends to enrol nearly 80 healthy subjects into the trial in the UK.

Moleculin Biotech chairman and CEO Walter Klemp said: “We believe the antiviral effect demonstrated by WP1122 in preclinical models to date suggests that the drug may have the potential to meet the critical need for a pan-viral therapy that could address not only Covid-19 and its variants, but also other viruses that cause human disease.

“As we are also developing this drug for human cancers, this Phase I trial may also provide information that helps advance our cancer research.”

In April this year, the company announced plans to initiate a Phase I trial of WP1066 for treating recurrent malignant glioma.