Tiziana Completes Last Patient Visit in Phase 2a INFORM-MS Trial; Topline Data Due October
TLSA sits 19% above its 52-week low of $0.762.
Summary
Tiziana announced the last patient completed the last visit in its Phase 2a INFORM-MS trial of intranasal foralumab in na-SPMS. Database lock is expected this week, with topline 12-week data due in October.
Key Events · Product Development and Regulatory · TLSA
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Last Patient Completes Last Visit
The final patient completed the last visit in the Phase 2a INFORM-MS trial of intranasal foralumab in na-SPMS, a randomized, double-blind, placebo-controlled study of 48 patients across three cohorts.
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Topline Data Expected in October
Tiziana expects to lock the database this week and announce 12-week treatment topline data in October 2026, with the primary endpoint being change in microglial activation measured by PET imaging.
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Open-Label Extension Offered to All Participants
Following the blinded phase, all participants — including those initially on placebo — may receive intranasal foralumab in a six-month follow-on open-label extension to generate longer-term safety and efficacy data.
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Expanded Access Program Shows Stabilization or Improvement
Data from the Expanded Access Program in na-SPMS showed most patients treated with intranasal foralumab either stabilized or improved in clinical outcomes over extended treatment duration, supporting the OLE design.
Analysis · TLSA · Life Sciences
The last patient has completed the final visit in the Phase 2a INFORM-MS trial of intranasal foralumab in non-active secondary progressive multiple sclerosis (na-SPMS). Database lock is expected this week, with 12-week topline data to be announced in October. This is a pivotal near-term catalyst for a company whose lead asset is the only fully human anti-CD3 monoclonal antibody in clinical development. The trial enrolled 48 patients across three cohorts, and all participants — including those on placebo — can enter a six-month open-label extension. Positive topline data would validate the mechanism and support advancement toward later-stage development; negative or mixed data would materially impair the investment thesis.
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At the time of this filing, TLSA was trading at $0.91 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $116.2M. The 52-week trading range was $0.76 to $2.35. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.