REGN7508 / Regeneron - LARVOL DELTA

ROXI-ATLAS: Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation (clinicaltrials.gov) - P2 | N=1200 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Atrial Fibrillation • Cardiovascular

ROXI-ASPEN: REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants (clinicaltrials.gov) - P3 | N=2000 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P3 trial • Cardiovascular • Orthopedics • Pain • Venous Thromboembolism

ROXI-ATLAS: Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation (clinicaltrials.gov) - P2 | N=1200 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Atrial Fibrillation • Cardiovascular

ROXI-APEX: REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults (clinicaltrials.gov) - P3 | N=2000 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Orthopedics • Pain • Venous Thromboembolism

Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=224 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion

Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=224 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2025 ➔ Jul 2025 | Trial primary completion date: Aug 2025 ➔ Apr 2025

Enrollment closed • Trial completion date • Trial primary completion date

ROXI-APEX: REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults (clinicaltrials.gov) - P3 | N=2000 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P3 trial • Cardiovascular • Orthopedics • Pain • Venous Thromboembolism

Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=224 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Jul 2025 ➔ Nov 2025 | Trial primary completion date: Apr 2025 ➔ Aug 2025

Trial completion date • Trial primary completion date

ROXI-VTE II: A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants (clinicaltrials.gov) - P2 | N=179 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Musculoskeletal Diseases • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

Regeneron to Advance Two Factor XI Antibodies into a Broad Phase 3 Program Following Positive Phase 2 Proof-of-concept Results (GlobeNewswire) - P2 | N=373 | ROXI-VTE-I (NCT05618808) | P2 | N=179 | ROXI-VTE II (NCT06454630) | Sponsor: Regeneron Pharmaceuticals | "'We are eager to advance REGN7508 and REGN9933 into a broad Phase 3 program beginning in 2025.'...a pooled analysis across both trials showed REGN7508 was superior to enoxaparin and non-inferior to apixaban, and REGN9933 was non-inferior to enoxaparin. All VTE events were asymptomatic, except for one symptomatic case of pulmonary embolism in the apixaban arm...There was no major bleeding (including surgical site bleeding) or clinically relevant non-major bleeding in any arm; the only treatment-related adverse events (AE) in any arm was one case of minimal bleeding (contusion) reported in the enoxaparin arm of ROXI-VTE-I. There were no treatment-related serious AEs (SAEs) in any arm. There were also no AEs in any arm leading to trial discontinuation or dose interruption/modification, and no AEs of special interest or deaths in these trials."

New P3 trial • P2 data • Venous Thromboembolism

ROXI-VTE II: A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants (clinicaltrials.gov) - P2 | N=179 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Musculoskeletal Diseases • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=224 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Disorder

ROXI-CATH: A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC) (clinicaltrials.gov) - P2 | N=195 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Thrombosis • Venous Thromboembolism

A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants (clinicaltrials.gov) - P1 | N=80 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion

ROXI-VTE II: A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Musculoskeletal Diseases • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed

Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=224 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

Combination therapy • New P1 trial • Gastrointestinal Disorder

ROXI-VTE II: A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Cardiovascular • Musculoskeletal Diseases • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

ROXI-CATH: A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC) (clinicaltrials.gov) - P2 | N=195 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Cardiovascular • Thrombosis • Venous Thromboembolism

A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Mar 2024 ➔ Aug 2024 | Trial primary completion date: Mar 2024 ➔ Aug 2024

Trial completion date • Trial primary completion date

A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open

A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P1 trial