BB-031 / Basking Biosci - LARVOL DELTA

Study of BB-025, Alone and After BB-031, in Healthy Volunteers (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Basking Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

VWF INHIBITION BY APTAMER BB-031 PROVIDES SYNERGISTIC THROMBOLYSIS WITH TENECTAPLASE IN ACUTE ISCHEMIC STROKE PATIENT BLOOD (WSC 2025) - "VWF inhibition by BB-031 demonstrates thrombolytic synergism with Tenecteplase (TNK). We anticoagulated AIS patient whole blood in sodium citrate vacutainers for Halo assay analysis and added 25 ul to 5 uL of clotting reagent in a 96 well format. As TNK is rapidly replacing rtPA as the AIS treatment gold standard, VWF inhibition by BB-031 may provide additional thrombolysis without hemorrhage risk."

Clinical • Cardiovascular • Hematological Disorders • Ischemic stroke

Study of BB-031 in Acute Ischemic Stroke Patients (RAISE) (clinicaltrials.gov) - P2 | N=156 | Recruiting | Sponsor: Basking Biosciences, Inc. | Trial completion date: Mar 2027 ➔ Sep 2027 | Trial primary completion date: Dec 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

Study of BB-025, Alone and After BB-031, in Healthy Volunteers (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Basking Biosciences, Inc.

New P1 trial

Von Willebrand factor A1 blockade prevents platelet-mediated reocclusion in a microfluidic model of arterial thrombosis (ISTH 2025) - "BB-031 inhibition of VWF-A1 reduced new platelet incorporation (2.786±0.806e9 vs. 6.796±1.234e9, p=0.0172) and increased recanalization (1.354±1.433g vs. 0.297±0.497g, p=0.0016) compared to vehicle (Fig2E-H). Table or Figure Upload"

Cardiovascular • Hematological Disorders • Myocardial Infarction • Thrombosis • ITGA2B

Improvement in Microfluidic Patency with Von Willebrand Factor Aptamer in Ischemic Stroke Patients (ISTH 2025) - "BB-031 treatment 3 hours post-occlusion increased outflow 0.951±1.279g compared to 0.156±0.266g with vehicle, 0.487±0.597g with Alteplase, and 0.249±0.328g with Tenecteplase (mean±SD). In stroke patient samples, BB-031 significantly increased outflow compared to vehicle(p<0.05)(Fig2A-B). Table or Figure Upload"

Clinical • Cardiovascular • Hematological Disorders • Ischemic stroke • Thrombosis • ITGA2B

BB-031 IN ACUTE TREATMENT: SAFETY, TOLERABILITY, PHARMACOKINETICS (PK) AND PHARMACODYNAMICS (PD) IN ACUTE ISCHEMIC STROKE – THE RAISE TRIAL (ESOC 2025) - P2 | "The RAISE trial is the first patient trial of BB-031 evaluating vWF inhibition in the treatment of Acute Ischemic Stroke. Results from the RAISE trial will help define future efficacy trials."

Clinical • PK/PD data • Cardiovascular • Ischemic stroke • Thrombosis

Von Willebrand Factor Inhibition by BB-031 Prevents and Thrombolyses Clots in a Murine Model of Venous Thrombosis (AHA 2024) - "Treatment after JVO resulted in no difference compared to vehicle in male WT mice, but BB-031-treated WT females resulted in 76.09% recanalization 35 minutes after occlusion compared to rtPA (9.64%, p<0.0001), heparin (30.95%, p=0.7306), or vehicle (22.07%, p<0.0001), (n=5/group). Male DIO mice significantly reperfused with BB-031 (100%) vs rtPA (10.52%), heparin (4.54%), and vehicle (22.50%), p<0.0001, (n=4-6/group).ConclusionVWF inhibition by BB-031 maintains patency in a VTE murine model offering future therapeutic alternatives."

Preclinical • Cardiovascular • Genetic Disorders • Hematological Disorders • Obesity • Thrombosis • Venous Thromboembolism

VON WILLEBRAND FACTOR INHIBITION BY BB-031 EFFECTIVELY THROMBOLYSES IN A MICROFLUIDIC MODEL OF ARTERIAL THROMBOSIS (WSC 2024) - "Conclusions BB-031 thrombolysed stabilized thrombi in AIS blood under arterial shear stress resulting in significant patency. BB-031 VWF inhibition may offer a superior AIS therapeutic."

Cardiovascular • Hematological Disorders • Ischemic stroke • Thrombosis • ITGA2B

Von Willebrand factor targeted thrombolysis in canine basilar artery occlusion. (PubMed, Front Neurol) - "Targeted inhibition of VWF by BB-031 increased recanalization and reperfusion, and reduced infarct volume in a canine model of BAO stroke. It represents a promising target based on preliminary results for treating acute ischemic stroke."

Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Study of BB-031 in Acute Ischemic Stroke Patients (RAISE) (clinicaltrials.gov) - P2 | N=156 | Recruiting | Sponsor: Basking Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Ischemic stroke

Study of BB-031 in Acute Ischemic Stroke Patients (RAISE) (clinicaltrials.gov) - P2 | N=156 | Not yet recruiting | Sponsor: Basking Biosciences, Inc.

New P2 trial • Cardiovascular • Ischemic stroke

Study of DTRI-031 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=46 | Completed | Sponsor: Basking Biosciences, Inc. | Recruiting ➔ Completed

Trial completion

Effect of Novel Thrombolytic Aptamer DTRI-031 on Microfluidic Thrombolysis and VWF Function Dose-Response (ISTH 2022) - "VWF assays were inhibited by DTRI-031 (Figure 1) while VWF:Ag was, as expected, constant. MLE trended higher at the midrange dose. Correlation with dose was highest in VWF:Ac, VWF:RCo, and RIA, while MLE correlated best with T-TAS and VWF:Ag (Figure 2)."

Cardiovascular • Hematological Disorders • Thrombosis

Study of DTRI-031 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Basking Biosciences, Inc. | Trial completion date: Jan 2022 ➔ Apr 2022 | Trial primary completion date: Jan 2022 ➔ Apr 2022

Trial completion date • Trial primary completion date

Treatment With Vwf Inhibitor Dtri-031 In Combination With Rtpa Increases Thrombolytic Efficacy Compared To Rtpa Or Aspirin In Mouse, Canine, And Human Blood (ISC 2022) - "VWF inhibition by DTRI-031 aptamer + rTPA significantly improves clot lysis rate compared to monotherapy with rTPA, DTRI-031, and aspirin in mouse, canine, and human blood."

Combination therapy • Preclinical • Cardiovascular

Vwf Inhibitor Lyses Middle Cerebral Artery Occlusion After 6 Hours Of Large Vessel Occlusion Stroke (ISC 2022) - "DTRI-031 effectively recanalizes LVO after 6 hours of stroke onset with reduced infarct volume and no incidence of hemorrhage. DTRI-025 rapidly reverses DTRI-031. This drug/reversal agent combination represents a robust yet safe approach to treat AIS."

Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Immunology • Ischemic stroke • Thrombosis

Study of DTRI-031 in Healthy Volunteers (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Basking Biosciences, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Study of DTRI-031 in Healthy Volunteers (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Basking Biosciences, Inc.

New P1 trial