Delving into the Latest Updates on SY-162 with Synapse

Overview

Basic Info

Drug Type

Enzyme

Synonyms

Recombinant staphylokinase variant

Target

PLG

Mechanism

PLG stimulants(Plasminogen stimulants)

Therapeutic Areas

Cardiovascular Diseases

Active Indication-

Inactive Indication

Peripheral Arterial DiseasePeripheral arterial occlusive diseaseVenous Thromboembolism+ [1]

Originator Organization

Katholieke Universiteit Leuven

Active Organization-

Inactive Organization

Thrombogenics, Inc.

Katholieke Universiteit Leuven

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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BACKGROUNDWe investigated the safety and efficacy of several dosing regimens of catheter-directed staphylokinase (SY162) bolus administration for the treatment of long-term venous access catheter occlusion.METHODSThis open-label, ascending dose study enrolled 24 subjects. Three doses of SY162 were evaluated in three cohorts (0.15 mg, 0.3 mg and 0.45 mg) with eight subjects each. Catheter function was evaluated 30 min after the first bolus administration. In case of incomplete catheter function restoration, a second bolus was administered with reassessment of catheter function 30 min thereafter. Cathetergram was repeated to assess thrombus resolution.RESULTSComplete restoration of catheter withdrawal function was observed in 2 (25%), 1 (13%) and 7 (88%) subjects after the first bolus in the first, second and third cohort respectively and in 4 (50%), 7 (88%) and 7 (88%) patients after the second administration of SY162. There were no bleeding complications nor other adverse events related to SY162.CONCLUSIONSThe doses tested in this trial were well tolerated and safe. A dose-response effect within the dose range tested was observed. A 2 ml bolus injection of 0.45 mg SY162 resulted in optimal efficacy after 30 min.

100 Deals associated with SY-162

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Peripheral Arterial Disease	Phase 2	-	Thrombogenics, Inc.	-
Peripheral Arterial Disease	Phase 2	-	Katholieke Universiteit Leuven	-
Peripheral arterial occlusive disease	Phase 2	BE	Thrombogenics, Inc.	-
Venous Thromboembolism	Phase 2	-	Thrombogenics, Inc.	-
Venous Thromboembolism	Phase 2	-	Katholieke Universiteit Leuven	-
Venous Thrombosis	Phase 2	BE	Thrombogenics, Inc.	-