SUN-627 / Sundance Biosciences - LARVOL DELTA

Sundance has also initiated an additional Phase 2 clinical trial of SUN-627 (EUCT 2026-525817-29-00) in Finland (GlobeNewswire) - "The Finland Phase 2 clinical trial of SUN-627 is an open-label study in patients with primary progressive MS and non-active secondary progressive MS. The study will evaluate the safety, pharmacokinetics and pharmacodynamics of orally administered SUN-627, and will leverage imaging techniques that can directly quantify changes in neuroinflammation."

Trial status • Multiple Sclerosis

Sundance Biosciences Announces First Patient Dosed in U.S. Phase 2 Clinical Trial of SUN-627 for Progressive Forms of Multiple Sclerosis (MS) (GlobeNewswire) - "The U.S. Phase 2 clinical trial of SUN-627 (NCT07840326) is a randomized, double-blind, placebo-controlled study in patients with primary progressive MS and non-active secondary progressive MS....The trial will enroll approximately 20 participants who will receive SUN-627 or placebo daily for a 12-week treatment period. Sundance expects to complete the trial and have topline data by the end of 2027."

P2 data • Trial status • Multiple Sclerosis

Preclinical data presented by Sundance at the ACTRIMS-ECTRIMS Meeting included key mechanistic findings in experimental autoimmune encephalomyelitis (EAE), a widely utilized rodent model of MS, and cell culture experiments (GlobeNewswire) - "Direct impact of a brain-penetrant TYK2 inhibitor was shown on interferon-enriched activated microglia and astrocytes, which are resident in chronic active lesions that are a key feature of progressive MS pathology. Brain-penetrant TYK2 inhibition impeded interferon-dependent dendritic cell differentiation and antigen-meditated T cell activation, which drives smoldering neuropathology in MS."

Preclinical • Multiple Sclerosis

Sundance Biosciences Announces Presentation of Phase 1 Results for SUN-627, a Brain-Penetrant TYK2 Inhibitor for the Treatment of Multiple Sclerosis (MS) (GlobeNewswire) - "Results...presented at Joint ACTRIMS-ECTRIMS Meeting....SUN-627 was well-tolerated in healthy volunteers. There were no serious adverse events and all treatment-related adverse events were grade 1 (mild). SUN-627 demonstrated near complete inhibition of the TYK2 pathway, achieving greater than 90% reduction of key TYK2 pathway biomarkers for 24 hours with a once-daily dose, as well as a CNS-penetration ratio of 1 (unbound SUN-627 in CSF : unbound SUN-627 in plasma). Steady-state CSF exposure of SUN-627 is predicted to remain above the preclinically derived iPSC-microglial IC90 for ~24 hours at doses ≥40 mg once-daily."

P1 data • Multiple Sclerosis

A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS) (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Sundance Biosciences, Inc.

New P2 trial • CNS Disorders • Inflammation • Multiple Sclerosis

SUN-627-MS201: A Phase 2a Study of SUN-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Impact on Measures of Neuroinflammation in the Central Nervous System in Participants With Non-Active Progressive Multiple Sclerosis (SPMS/PPMS) (clinicaltrialsregister.eu) - P1/2 | N=30 | Not yet recruiting | Sponsor: Sundance Biosciences Inc.

New P1/2 trial • CNS Disorders • Inflammation • Multiple Sclerosis