Abstract WMP1: Results From A Phase 2a Study Of TMS-007, An SMTP Family Anti-inflammatory Prothrombolytic, On Patients With Acute Ischemic Stroke Up To 12 Hours After Onset

Stroke, Volume 53, Issue Suppl_1, Page AWMP1-AWMP1, February 1, 2022. Approved thrombolytic agents are limited in their use for the treatment of acute ischemic stroke (AIS) due to their benefit-risk profile beyond 4.5 h since last known normal (LKN). TMS-007 is a small molecule, SMTP family member with a novel mode of action: promotion of plasminogen-fibrin binding to enhance physiological thrombolysis while inhibiting inflammation at the site of thrombosis. TMS-007 may extend the treatment time window based on nonclinical pharmacological evidence. We evaluated TMS-007 in a randomized, placebo-controlled, double-blind, dose-escalation phase 2a study. TMS-007 or placebo was administered as a single intravenous infusion at a dose of 1, 3, or 6 mg/kg to AIS patients who were ineligible for t-PA or thrombectomy within 12 h of LKN. The number of patients allocated to placebo and TMS-007 at doses 1, 3, and 6 mg/kg were 38, 6, 18, and 28, respectively. The combined TMS-007 dosing group (Group T; n = 52) was compared with placebo group (Group P; n = 38). The average age was ~72 years old and time since LKN to treatment was ~9 h in both groups (not significantly different). The incidence of symptomatic intracranial hemorrhage (ICH) with worsening NIHSS score of

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Febbraio 2022