Tiziana Life Sciences has filed an amendment to get its oral antibody program back on track. After hitting a roadblock with its initial design, Tiziana has expanded the patient population and shortened the dosing period in a bid to wrap up the phase 1b by the end of the year.
The study will test oral anti-CD3 monoclonal antibody foralumab in patients with mild to moderately active Crohn’s disease. Tiziana encapsulated foralumab powder in an enteric-coated capsule to enable oral delivery and took the candidate through a phase 1 clinical trial in 2019. That done, Tiziana began preparing for a phase 1b/2 trial.
Progress has slowed since the end of phase 1. The FDA cleared Tiziana to start a phase 1b trial in Crohn’s, but the design proved to be a problem, with the company discovering it would be hard to enroll subjects.
“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 protocol has been amended to expedite patient enrollment and study completion,” Tiziana said in a statement.
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The amended protocol is designed to expand the pool of patients who are eligible for the clinical trial and cut the burdens the study puts upon them, potentially making it easier for Tiziana to enroll subjects. Now, Tiziana plans to dose patients for five consecutive days in the hospital or clinical research unit.
Tiziana is waiting for the FDA to comment on the amended protocol. If everything goes to plan, the study will finish by the fourth quarter, returning momentum to a program that stalled after early-phase tests.