Tiziana Life Sciences says that after receiving feedback from the FDA following a Type C meeting, the company plans to move forward with a Phase 2 trial of intranasal foralumab, a human anti-CD3 mAb, in patients with non-active secondary progressive multiple sclerosis. In September 2019, Tiziana announced results from its Phase 1 trial of intranasal foralumab. Since then, several MS patients have received intranasal foralumab as part of an expanded access program at Brigham and Women’s Hospital (BWH).
Tiziana Chief Medical Officer Matthew W. Davis commented, “I am grateful for the FDA’s thoughtful review of our Phase 2 plans for intranasal foralumab. This upcoming quarter, we will update the Phase 2 protocol with the FDA’s suggestions and plan to start the Phase 2 clinical trial by holding our first investigator’s meeting in Q3 2023.”
Interim CEO and Executive Chairman Gabriele Cerrone said, “Tiziana has reached an important regulatory milestone as it proceeds with the first ever intranasal foralumab clinical trial. The FDA’s response to our proposed Phase 2 program allows Tiziana’s to advance foralumab through the regulatory process as we strive to bring this novel treatment to patients with non-active SPMS.”
Read the Tiziana Life Sciences press release.
