brivekimig (SAR442970) / Sanofi - LARVOL DELTA

Sanofi's Phase II study of TNF-α/OX40L dual antibody was successful [Google translation] (163.com) - P2 | N=86 | HS OBTAIN (NCT05849922) | Sponsor: Sanofi | "On April 24, Sanofi revealed when announcing its first-quarter results that the Phase II study of brivekimig (SAR442970) for the treatment of hidradenitis suppurativa (HS) reached the primary endpoint....The results showed that among patients with moderate to severe HS who had not received treatment with biologics, the proportion of patients who achieved HiSCR50 in the brivekimig (once every 2 weeks) group was clinically significant compared with the placebo group. In other indicators, the brivekimig group also achieved clinically significant improvements. In addition, during the 28-week treatment period, the safety of brivekimig was in line with expectations, and no new safety signals were found."

P2 data • Hidradenitis Suppurativa

CHROMA CD: A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease (clinicaltrials.gov) - P2 | N=99 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

T1D OBTAIN: Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule (clinicaltrials.gov) - P2 | N=84 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

T1D OBTAIN: Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule (clinicaltrials.gov) - P2 | N=84 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

HS OBTAIN: A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=86 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Hidradenitis Suppurativa • Immunology • CRP

RESULT: A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease (clinicaltrials.gov) - P2 | N=84 | Recruiting | Sponsor: Sanofi | Initiation date: Aug 2024 ➔ Dec 2024

Trial initiation date • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Lupus Nephritis • Nephrology

11 Class 1 innovative drugs were approved for clinical trials in China for the first time!… [Google translation] (Sina Corp) - "Mengke Pharmaceuticals' Class 1 new drug MRX-5 tablets have been approved for clinical trials. The product is intended to treat infections caused by nontuberculous mycobacteria (NTM) that are sensitive to this product...Beite Pharmaceuticals' Class 1 new drug BPR-30221616 injection has been approved for clinical trials and is intended to be developed to treat transthyretin amyloid cardiomyopathy...The Class 1 new drug CM559 injection applied by Conoya has been approved for clinical trials and is intended to be developed to treat Alzheimer's disease...The Class 1 new drug ART101 injection filed by Ontop Biopharmaceuticals has been approved for clinical trials and is intended to be developed for the treatment of hypertension....Sanofi 's Class 1 new drug SAR442970 injection has been approved for clinical use and is intended to treat primary focal segmental glomerulosclerosis (FSGS) or primary minimal change nephropathy (MCD) in adults and adolescents aged 16 and above."

New trial • Alzheimer's Disease • Cardiomyopathy • Focal Segmental Glomerulosclerosis • Hypertension • Nontuberculous Mycobacterial Disease

RESULT Umbrella Trial in Primary Focal Segmental Glomerulosclerosis/Minimal Change Disease (KIDNEY WEEK 2024) - "We describe the protocol and operational feasibility for the Renal Efficacy Signaling UmbrelLa Trial (RESULT). RESULT is an innovative global Phase 2a randomized, placebo-controlled umbrella trial that simultaneously evaluates the safety and efficacy of 3 novel therapies targeting immunological pathways implicated in primary FSGS/MCD: frexalimab (anti-CD40L monoclonal antibody), SAR442970 (anti-OX40L and anti-TNFα bispecific), and rilzabrutinib (BTK-inhibitor). This global RESULT Phase 2a trial utilizes an innovative efficacy signal-seeking master protocol to simultaneously evaluate 3 immunologically active therapies in FSGS/MCD and is the first umbrella trial in nephrology. Operational feasibility and stakeholder feedback demonstrate high scientific and medical interest, as well as appropriateness of trial design and assessments."

Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Pediatrics • CD40LG • TNFSF4

RESULT: A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease (clinicaltrials.gov) - P2 | N=84 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Lupus Nephritis • Nephrology

RESULT: A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease (clinicaltrials.gov) - P2 | N=84 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Lupus Nephritis • Nephrology

HS OBTAIN: A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=86 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Hidradenitis Suppurativa • Immunology • CRP

HS OBTAIN: A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=114 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Hidradenitis Suppurativa • CRP

HS OBTAIN: A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=114 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Dermatology • Hidradenitis Suppurativa • CRP