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Tiziana Announces Initiation of Phase 1b Clinical Trial in Crohn’s Disease Patients to Evaluate Oral Capsules of Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody
This clinical trial, the first-ever oral immunotherapy for patients with mild-to-moderately active Crohn's Disease, is anticipated to be completed by Q4,
About this update from Tiziana Life Sciences Ltd
[{"type":"text","content":"This clinical trial, the first-ever oral immunotherapy for patients with mild-to-moderately active Crohn's Disease, is anticipated to be completed by Q4, 2022. NEW YORK, March 25, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences (Nasdaq: TLSA) (\"Tiziana\" or the \"Company\"), a biotechnology company enabling breakthrough immunotherapies via novel routes of monoclonal antibody delivery, today announced initiation of a Phase 1b clinical trial to evaluate orally administered enteric-coated capsules of foralumab in patients with mild-to-moderate Crohn's Disease (CD). This revised protocol, as previously outlined in the Company’s announcement on February 4, 2022, allows for the study of a broader patient population and a shorter dosing period. These protocol amendments or revisions are intended to expedite patient enrollment with study completion targeted for the fourth quarter of 2022. This study is the first multiple-dose study with orally administered enteric-coated capsules of foralumab in patients with CD. This study will initiate soon with patient enrollment in the second quarter of 2022. Enteric-coated capsules, containing doses up to 5 mg of foralumab, will be administered once-daily for five consecutive days to patients with mild-to-moderately active CD. While the primary objective is safety and tolerability, additional endpoints are to assess clinical and immune signal responses, including calprotectin measurements in stool. Blood samples will be collected to evaluate pharmacokinetics, including the rate and extent of systemic absorption. The presence of anti-drug antibodies (ADAs) will also be determined. Typically, therapeutic antibodies are administered either intravenously or subcutaneously, but severe and sometimes life-threatening side effects may occur. Oral administration with foralumab is a novel approach to induce an anti-inflammatory immune response via site-targeted immunomodulation in the gut. Previous mouse and patient studies have demonstrated that orally delivered anti-CD3 antibody effectively ameliorates gut inflammation in a murine model of colitis1 and in patients with moderate-to-severe ulcerative colitis2. Currently, commonly used immunotherapies for CD require intravenous or subcutaneous administration of anti-TNF-alpha antibodies, such as HUMIRA®, REMICADE®, and anti-CD23 antibodies (STELARA®). Dr. Kun...