SUDO-550 / Sudo Biosci - LARVOL DELTA

Pharmacological Characterization of SUDO-550, a Novel Oral CNS Penetrant TYK2 Inhibitor (ACTRIMS Forum 2026) - "SUDO-550 is a highly potent inhibitor of TYK2-dependent pathways in key cell populations which drive peripheral and CNS inflammation in MS and is efficacious in a rat experimental model of MS. These data are supportive of the clinical development of SUDO-550 as a therapeutic approach for MS and other neuroinflammatory and neurodegenerative diseases."

CNS Disorders • Immunology • Inflammation • Multiple Sclerosis • IL23A • NEFL • TYK2

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SUDO-550: Phase 1 Trial of a Brain-Penetrant Selective TYK2 Inhibitor in Healthy Volunteers Following Single and Multiple Ascending Doses (ACTRIMS Forum 2026) - "Single ascending doses (SAD) of SUDO-550 were given in two parts (Part A double-blind, placebo-controlled and Part D 3-way cross-over fasted, fed and with concomitant famotidine) in healthy adults 18 to 55 years of age. SUDO-550 demonstrated a safe and tolerable profile, including in healthy adults aged ≥65 years, with PK consistent with once daily dosing maintaining pharmacologically active plasma and CSF concentrations over 24 hours. These Phase 1 data support continued clinical development and future trials with SUDO-550 for the treatment of MS and diseases with features of neuroinflammation."

Clinical • P1 data • PK/PD data • CNS Disorders • Inflammation • Multiple Sclerosis • TYK2

Sudo Biosciences Announces First Participants Dosed in Phase 1 Trial of Brain-Penetrant Allosteric TYK2 Inhibitor SUDO-550 (Businesswire) - "Sudo Biosciences...announced today that the first participants have been dosed in a Phase 1 clinical trial evaluating SUDO-550, a novel brain-penetrant allosteric TYK2 inhibitor for the treatment of neuroinflammatory diseases. The Phase 1 clinical trial is designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple-ascending doses of SUDO-550 in healthy volunteers, including confirmation that the compound effectively crosses the blood-brain barrier."

Trial status • Immunology • Inflammation

Sudo Biosciences Announces Second Close of Upsized Series B Financing Bringing Total Raised in Round to $147M (Businesswire) - "Sudo Biosciences...today announced that during January 2024, it completed a second close of its Series B financing, raising an additional $30 million from new investors Dementia Discovery Fund (DDF, a SV Health Investors Fund), Leaps by Bayer, and UPMC Enterprises, the innovation, commercialization and venture capital arm of UPMC. This brings the total raised in this upsized round to $147 million....Proceeds from the Series B fundraise will be used to advance two investigational TYK2 candidates into the clinic this year."

Financing • Immunology