balinatunfib (SAR441566) / Sanofi - LARVOL DELTA

SPECIFI-RA: A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=264 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

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

Balinatunfib: A Clinical Oral Small Molecule TNFα Inhibitor. (PubMed, ChemMedChem) - "The oral route of administration confers practical advantages in terms of patient compliance and could facilitate drug access to sites traditionally less amenable to biologics, such as the central nervous system. By demonstrating that small molecules can achieve high-affinity, conformation-based inhibition of TNFα, balinatunfib, and related compounds may result in a new area of orally administered therapies that advance the management of TNFα-mediated diseases."

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

Selective inhibition of TNFR1 signal by balinatunfib in vitro does not inhibit Treg expansion in contrast to anti-TNF biologics inhibiting TNFR1 and TNFR2 signaling (EULAR 2025) - "Treatment with balinatunfib that selectively binds to sTNF and inhibits TNFR1 signal does not inhibit the mTNF–TNFR2 mediated induction of T reg cells, confirming TNFR2 signal sparing by balinatunfib. Induction of CD45 + CD4 + CD25 + FoxP3 + T reg cells in co-culture with memTNF-CHO cells for 48h in the presence or absence of TNFR1 signalling inhibitor balinatunfib, or the TNF blocking biologics etanercept and adalimumab. Triplicate measurements were performed from five donors."

Preclinical • Dermatology • Immunology • Oncology • Psoriasis • ADAM17 • FOXP3 • IL2 • IL2RA • PTPRC • TNFRSF1A

Sanofi axes development of oral TNF inhibitor as monotherapy following Phase II fail (Clinical Trials Arena) - P2 | N=221 | SPECIFI-PSO (NCT06073119) | Sponsor: Sanofi | "Sanofi will halt the development of its oral tumour necrosis factor (TNF) inhibitor balinatunfib as a monotherapy after it failed to reach the primary endpoint in a Phase II trial. Preliminary results from the SPECIFIC-PSO Phase II study (NCT06073119) in patients with psoriasis showed that balinatunfib achieved clinically relevant changes in the primary endpoint – the PASI-75 response – with efficacy levels comparable to other oral medicines in psoriasis. However, it did not reach statistical significance. Sanofi said this miss was due to 'the nature of this limited Phase II study. PASI-75 is a commonly used metric which measures whether a patient has benefited from a 75% reduction in symptoms compared to baseline....The company plans to present full data at an upcoming medical meeting."

Discontinued • P2 data • Psoriasis

Balinatunfib: Data from P2 SPECIFI-RA trial (NCT06073093) for rheumatoid arthritis in H2 2025 (Sanofi) - Q1 2025 Results

P2 data • Rheumatoid Arthritis

SPECIFI-RA: A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=264 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

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

First-in-Human Single and Multiple Ascending Dose Studies of Balinatunfib, a Small Molecule Inhibitor of TNFR1 Signaling in Healthy Participants. (PubMed, Clin Pharmacol Ther) - "As the main PD read-out, complete TNFα occupancy was shown at all tested time points after the treatment started. Balinatunfib, as the first clinically tested oral TNFR1 signal inhibitor, demonstrated a good safety profile along with favorable PK/PD characteristics that allowed both once and twice daily dosing, confirming a successful preclinical-to-clinical translation and guiding dose selection for further clinical efficacy studies."

Journal • P1 data • Immunology • Oncology • TNFA • TNFRSF1A

SPECIFI-UC: A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis (clinicaltrials.gov) - P2 | N=204 | Recruiting | Sponsor: Sanofi

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SPECIFI-PSO: A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis (clinicaltrials.gov) - P2 | N=221 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Trial completion • 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 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting | Trial primary completion date: Mar 2025 ➔ Jul 2027

Enrollment open • Trial primary completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

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