SAR441566 / Sanofi - LARVOL DELTA

Qualitative Literature Review to Explore the Patient Experience of Rheumatoid Arthritis and Unmet Treatment Needs to Inform Clinical Trial Patient-Reported and Digital Endpoints (ISPOR-EU 2024) - P2 | "OBJECTIVES: Clinical studies are underway to support development of SAR441566, a tumor necrosis factor receptor 1 inhibitor as a treatment for Rheumatoid Arthritis (RA) (NCT06073093)... The models hypothesize how patients link signs and symptoms to impacts on patients’ daily life and what is meaningful to achieve with treatment. Patients will be interviewed in 2024 to better understand their MAH to inform the models and select patient-informed trial PROs and digital endpoints that are of clinical relevance to RA patients."

Clinical • Review • Fatigue • Immunology • Inflammatory Arthritis • Musculoskeletal Diseases • Musculoskeletal Pain • Oncology • Orthopedics • Pain • Rheumatoid Arthritis • Rheumatology • TNFA

CDSCO panel approves Sanofi Healthcare's protocol amendment proposal to study SAR441566 (Medical Dialogues) - "The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Sanofi Healthcare India for the protocol amendment of the study titled, 'A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis (SPECIFI-RA)'....This came after the firm presented protocol amendment 3 version 01 dated 03 July 2024 protocol no. DRI17821 and an increase in number of subjects from 10 to 24."

Clinical protocol • Rheumatoid Arthritis

SPECIFI-RA: A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Sanofi | N=817 ➔ 240

Enrollment change • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

SPECIFI-RA: A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=817 | Recruiting | Sponsor: Sanofi | N=240 ➔ 817

Enrollment change • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

SPECIFI-PSO: A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis (clinicaltrials.gov) - P2 | N=207 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

SPECIFI-CD: A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease. (clinicaltrials.gov) - P2 | N=260 | Not yet recruiting | Sponsor: Sanofi

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

SPECIFI-PSO: A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis (clinicaltrials.gov) - P2 | N=207 | Recruiting | Sponsor: Sanofi | Trial completion date: May 2025 ➔ Feb 2025 | Trial primary completion date: Apr 2025 ➔ Jan 2025

Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

SAR441566: Regulatory submission for rheumatoid arthritis in 2027 or later (Sanofi) - AGM 2024

Regulatory • Rheumatoid Arthritis

Sanofi (SNY.US) oral drug TNFα inhibitor approved for clinical use in China (Investing.com) - "Zhitong Finance APP learned that on March 1, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that Sanofi (SNY.US) Class 1 new drug SAR441566 has been approved for clinical use and is planned to be developed to treat moderate to severe rheumatoid joints. It is indicated for rheumatoid arthritis (RA) and moderate to severe plaque psoriasis."

Non-US regulatory • Psoriasis • Rheumatoid Arthritis

A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566 (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Sanofi | Recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

SPECIFI-PSO: A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis (clinicaltrials.gov) - P2 | N=207 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

SPECIFI-RA: A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

The Potential of an Oral TNFα Inhibitor with TNFR1 Specificity: Results of a Phase 1b Proof-of-mechanism Trial in Psoriasis (ACR Convergence 2023) - "This phase 1 study demonstrated that this novel oral TNFa inhibitor was safe, well tolerated, and clinically effective, to be further confirmed in larger trials. Limitations include the sample size and homogeneous population. A computational disease platform is being applied to translate psoriasis results to estimate the efficacy of SAR441566 for RA."

P1 data • Dermatology • Hematological Disorders • Immunology • Inflammatory Arthritis • Psoriasis • Rheumatoid Arthritis • Rheumatology • IL17A • TNFRSF1A • TNFRSF1B

SPECIFI-PSO: A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis (clinicaltrials.gov) - P2 | N=207 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Dermatology • Immunology • Psoriasis

SPECIFI-RA: A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Efficacy and safety of a small molecule with innovative inhibition of TNFR1 signalling in plaque psoriasis: A double-blind, randomized, placebo-controlled study (EADV 2023) - "SAR441566, a specific inhibitor of TNFR1 signalling, demonstrated clinical efficacy in mild-to- moderate psoriasis over a 4-week treatment period. This novel oral therapy was safe and well-tolerated. The results support the mechanism of action of SAR441566, a small molecule inhibitor of TNFR1 signalling and warrants further clinical evaluation in psoriasis."

Clinical • Dermatology • Immunology • Oncology • Psoriasis • TNFRSF1A • TNFRSF1B

Biomarker response to a novel orally administrated small molecule inhibitor of TNFR1 signalling for plaque psoriasis (EADV 2023) - "Substantial decline in serum levels of IL-22, IL-17F and IL-17A was observed after selective TNFR1 signalling inhibition with SAR441566 treatment for 4 weeks, while there was a marginal reduction in hs-CRP levels. The decreases in biomarker levels were consistent with the observed clinical improvement noted in patients receiving SAR441566. These results support the mechanistic basis for SAR441566 clinical activity in plaque psoriasis and warrants further clinical development."

Biomarker • Dermatology • Immunology • Oncology • Psoriasis • CRP • IL17A • IL22 • TNFRSF1A

A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants. (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Sanofi | Recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566 (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants. (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants. (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Sanofi

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566 (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Sanofi

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study to Investigate Safety, Tolerability and Clinical Response With SAR441566 Compared With Placebo in Participants With Mild to Moderate Psoriasis (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: Sanofi | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

An orally available small molecule that targets soluble TNF to deliver anti-TNF biologic-like efficacy in rheumatoid arthritis. (PubMed, Front Pharmacol) - "The molecule, SAR441566, stabilizes an asymmetrical form of the soluble TNF trimer, compromises downstream signaling and inhibits the functions of TNF in vitro and in vivo. With SAR441566 being studied in healthy volunteers we hope to deliver a more convenient orally bioavailable and effective treatment option for patients suffering with chronic autoimmune diseases compared to established biologic drugs targeting TNF."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Oncology • Rheumatoid Arthritis • Rheumatology • TNFA

A Study to Investigate Safety, Tolerability and Clinical Response With SAR441566 Compared With Placebo in Participants With Mild to Moderate Psoriasis (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Sanofi

New P1 trial • Dermatology • Immunology • Psoriasis