Tiziana Receives Sign-Off From The FDA To Proceed With Phase 2 Clinical Trial In Patients With Non-Active Secondary Progressive Multiple Sclerosis (SPMS)

Tiziana Life Sciences Ltd. TLSA announced it has received feedback based on the U.S. Food and Drug Administration (FDA) Type C meeting minutes related to the Phase 2 clinical trial of intranasal foralumab in patients with non-active SPMS. Tiziana plans to accept the FDA’s recommendations and intends to start a Phase 2 study in the third quarter of 2023 as previously announced. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb).

“Tiziana has reached an important regulatory milestone as it proceeds with the first ever intranasal foralumab clinical trial,” commented Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer. “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.”

“I am grateful for the FDA’s thoughtful review of our Phase 2 plans for intranasal foralumab,” stated Matthew W. Davis, M.D., RPh, Chief Medical Officer.  “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.” 

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