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MechanismPI3Kβ inhibitors |
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Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Not yet recruitingPhase 2 Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion
Co-STAR is a multicenter, prospective, open-label, Bayesian Optimal Phase 2 (BOP2) trial that aims to assess the safety and efficacy of adjunctive intravenous TBO-309 in Acute Ischaemic Stroke (AIS) patients with tandem occlusion receiving intra-cranial endovascular thrombectomy (EVT) and acute extracranial carotid artery stenting.
Co-STARS study will test the hypothesis that patients with tandem occlusion treated with EVT and acute stenting in conjunction with TBO-309 will:
* have persistent stent patency without requiring rescue therapy with GPIIb/IIIa inhibitors and
* not experience high rates of symptomatic intra-cranial haemorrhage (sICH).
Patients with tandem occlusion undergoing EVT and acute stenting will receive intravenous TBO-309 bolus and infusion. TBO-309 is a potent, selective and ATP competitive PI3K[beta] inhibitor which reduces platelet activation adhesion/aggregation particularly under conditions of disturbed blood flow and promotes platelet disaggregation. By targeting PI3K[beta], TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal hemostasis.
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