SAR444336 / Sanofi - LARVOL DELTA

ACT18053: A study to investigate the efficacy and safety of SAR444336 in adults with microscopic colitis in clinical nremission. (clinicaltrialsregister.eu) - P1/2 | N=78 | Recruiting | Sponsor: Sanofi-Aventis Recherche & Developpement

New P1/2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology

A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission (clinicaltrials.gov) - P2 | N=54 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology

A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission (clinicaltrials.gov) - P2 | N=54 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology

The IL-2 SYNTHORIN molecule promotes functionally adapted Tregs in a preclinical model of type 1 diabetes. (PubMed, JCI Insight) - "Recently, we showed that the non-beta IL-2 SYNTHORIN molecule SAR444336 (SAR'336) can bypass the induction of autoimmune and inflammatory responses by increasing its reliance on IL-2 receptor α chain subunit (CD25) to provide a bona fide IL-2 signal selectively to Tregs, making it an attractive approach for the control of autoimmunity...Specifically, SAR'336 promoted the differentiation of IL-33-responsive (ST2+), IL-10-producing GATA3+ Tregs over other Treg subsets in the pancreas, demonstrating the ability of this molecule to further orchestrate Treg adaptation. These results offer insight into the capacity of SAR'336 to generate highly specialized, tissue-localized Tregs that promote restoration of homeostasis during ongoing autoimmune disease."

Journal • Preclinical • Developmental Disorders • Diabetes • Immunology • Inflammation • Metabolic Disorders • Type 1 Diabetes Mellitus • CD8 • FOXP3 • GATA3 • IL10 • IL2 • IL2RA • IL33 • ISG20

A CD25-biased interleukin-2 for autoimmune therapy engineered via a semi-synthetic organism. (PubMed, Commun Med (Lond)) - "SAR'336 is a specific Treg activator, supporting its further development for the treatment of AI diseases."

IO biomarker • Journal • Immunology • Inflammation • CD4 • CD8 • FOXP3 • ICOS • IL2 • IL2RA • ISG20

Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single and Repeated Doses of SAR444336 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=76 | Completed | Sponsor: Sanofi | Recruiting ➔ Completed

Trial completion • CRP

Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single and Repeated Doses of SAR444336 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Sanofi

New P1 trial • CRP