Citius Pharmaceuticals has enrolled the first subject in the Phase IIb clinical trial of its therapy Halo-Lido to treat haemorrhoids.
The company anticipates results from the trial in the second half of next year.
A topical formulation of halobetasol and lidocaine, Halo-Lido is designed to offer symptomatic relief to people with haemorrhoids.
On securing the US Food and Drug Administration (FDA) approval, Halo-Lido could become the first prescription product indicated to treat haemorrhoids.
The double-blind, randomised, multicentre, dose-ranging, parallel-group comparison trial will have five cohorts of adult subjects with symptomatic Goligher’s classification Grade II or Grade III haemorrhoids.
It will enol a total of 300 subjects with nearly 60 subjects in each cohort.
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Assessing the ability of the formulations of Halo-Lido used in each cohort to offer relief to trial subjects with acute flare-ups is the main goal of the trial.
Furthermore, the trial will assess the decline in haemorrhoidal symptoms including pain, burning, itching, and swelling on receiving Halo-Lido as the primary endpoint.
It is intended to offer the foundation for the development of the Phase III trial.
Citius Pharmaceuticals executive chairman Leonard Mazur said: “We are pleased to have initiated the Halo-Lido study and expect to complete enrolment later this year.
“Currently, there are no FDA-approved prescription-strength treatments available to the millions of adults who suffer from haemorrhoid discomfort each year.
“Assuming study results are positive, and in order to realise the full potential of Halo-Lido, we intend to seek strategic or financial partners for this asset at the appropriate time.”
Haemorrhoid is a gastrointestinal disorder that causes pain, swelling, itching, tenderness and bleeding.
The company enrolled the first patient in a Phase III trial of Mino-Loktherapy plus systemic antibiotics to treat catheter-related bacteremias (CRBSIs) in February 2018.