Tiziana Life Sciences has commenced a Phase Ib clinical trial of oral enteric-coated capsules of foralumab (TZLS-401), a monoclonal antibody (mAb), in mild-to-moderate Crohn’s disease (CD) patients.

Foralumab is a completely human anti-cluster of differentiation 3 (CD3) mAb.

It was demonstrated to lower cytokine release following intravenous (IV) dosing in healthy subjects and CD patients.

Oral dosing of foralumab is a new way to elicit an anti-inflammatory immune response through site-targeted immunomodulation in the gut.

According to the revised protocol, the trial permits for assessment in a wider subject population and over a reduced dosing period.

Tiziana added that the protocol amendments announced in February are aimed at accelerating subject enrolment to conclude the trial by the fourth quarter of the year.

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The multiple-dose trial will start enrolling subjects in the second quarter of the year.

In the trial, subjects will be given enteric-coated capsules containing doses of up to 5mg of foralumab once a day for five days.

The safety and tolerability of the oral therapy is the primary objective of the trial.

Clinical and immune signal responses, including calprotectin levels in stool, will be assessed as further endpoints.

Furthermore, blood samples will be obtained to analyse pharmacokinetics, including systemic absorption rate and extent, and anti-drug antibody development.

Tiziana Life Sciences CEO and chief scientific officer Dr Kunwar Shailubhai said: “We have developed proprietary formulation technologies, enabling oral, nasal and inhalation routes for administration of antibodies, to facilitate local action at the respective target sites.

“We believe this Phase Ib study is a logical first step towards the clinical validation of oral immunotherapy with foralumab capsules, to provide local action rather than systemic delivery, for CD treatment.”

According to prior data from studies, the oral anti-CD3 antibody could ameliorate inflammation in the gut in a murine model of colitis and moderate-to-severe ulcerative colitis patients.

A chronic inflammatory bowel disease, Crohn’s disease affects the lining of the digestive tract.

Last March, the company announced plans to initiate a Phase II trial of its nasal dose of foralumab in moderate to severe hospitalised Covid-19 patients in Brazil.