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Tiziana Announces Submission of Amendment to Investigational New Drug Application to Advance Oral Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Patients with Crohn’s Disease
- Tiziana is Developing the First Oral Form of Foralumab in a Convenient Capsule to be Evaluated in Phase 1b Clinical Study NEW YORK, Feb. 04, 2022 (GLOBE
About this update from Tiziana Life Sciences Ltd
[{"type":"text","content":"- Tiziana is Developing the First Oral Form of Foralumab in a Convenient Capsule to be Evaluated in Phase 1b Clinical Study NEW YORK, Feb. 04, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug delivery, today announced submission of an amendment to an Investigational New Drug (IND) application for evaluation of orally administered capsules of foralumab, which it believes would be the first “take home” immunotherapy, in patients with mild-to-moderately active Crohn’s Disease. If accepted by the U.S. Food and Drug Administration (FDA), the amendment is expected to expedite patient enrollment and completion of the foralumab Phase 1b study by the fourth quarter of 2022. The currently planned Phase 1b study with an amended protocol is designed as a placebo-controlled, randomized and dose-escalating trial, in mild-to-moderate patients with Crohn’s Disease. The patients will be dosed up to 5 mg once daily for five consecutive days and safety of patients will be monitored throughout the treatment period in the hospital or clinical research unit (CRU). The primary objective of this study is to determine safety and tolerability. The study will also evaluate the pharmacodynamic (PD) effects on modulation of immunobiomarkers, including calprotectin, a widely used biomarker for gut inflammation, in stools, as a secondary endpoint. Data from an earlier Phase 1a, single-ascending dose (SAD) study with orally administered foralumab in healthy volunteers determined that the treatment was well-tolerated up to 5 mg, which was the highest dose tested. This amendment would allow for the investigation of a broader patient population as well as a shorter dosing period. Previously, Tiziana had submitted an IND to conduct a Phase 1b study in moderate-to-severe active Crohn’s Disease patients to evaluate safety of enteric-coated foralumab capsules administered orally once daily for 14 days as an inpatient study in the hospital or CRU with safety monitoring, for which the FDA issued a ‘Study May Proceed letter’. However, initial feasibility findings indicated that enrollment of patients in this initial safety study, requiring 14-day hospitalization, was highly challenging due to the COVID-19 pandemic. Thus, the clinical prot...