Sundance Biosciences Announces First Patient Dosed in U.S. Phase 2 Clinical Trial of SUN-627 for Progressive Forms of Multiple Sclerosis (MS)

Phase 2 trial to evaluate SUN-627, a potent, highly-selective, brain-penetrant, oral allosteric TYK2 inhibitor, in people with progressive forms of MS

Novel brain-penetrant TYK2 inhibitor offers differentiated approach for the treatment of progressive forms of MS, targeting immune cells that drive neuroinflammation behind the blood-brain barrier

SOUTH SAN FRANCISCO, Calif., Oct. 22, 2026 (GLOBE NEWSWIRE) -- Sundance Biosciences, a biotechnology company advancing next-generation TYK2 (tyrosine kinase 2) inhibitors for individuals suffering from multiple sclerosis (MS) and other immune-mediated diseases, today announced that the first patient has been dosed in the U.S. Phase 2 clinical trial of SUN-627, a potent, highly-selective, brain-penetrant, oral allosteric TYK2 inhibitor, in people with progressive forms of MS. Sundance has initiated another Phase 2 study with an open-label trial design for SUN-627 in progressive forms of MS that is underway in Finland. As a novel brain-penetrant approach to inhibiting TYK2, SUN-627 is designed to target B cell and T cell signaling, astrocyte activation, and microglial activation behind the blood-brain barrier, potentially addressing the chronic neuroinflammation that is closely associated with progressive forms of MS.

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 study will evaluate the safety, pharmacokinetics and pharmacodynamics of orally administered SUN-627, including evaluation of biomarkers in the cerebrospinal fluid (CSF) associated with clinical worsening in patients with progressive forms of 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.

“The dosing of the first patient in the SUN-627 Phase 2 clinical trial marks a pivotal milestone in research for progressive forms of MS.” said Dr. Aaron Boster, a board-certified neurologist specializing in Multiple Sclerosis, President of the Boster Center for Multiple Sclerosis in Columbus, Ohio, and study investigator. “For the first time, we may have the opportunity to directly target smoldering neuroinflammation behind the blood-brain barrier, a critical gap in available therapies for progressive forms of MS. This trial is measuring important markers in the CSF that will be valuable for understanding the ability of a brain-penetrant TYK2 inhibitor to directly impact the inflammatory cascade driving clinical worsening in MS patients who have very limited therapeutic options.”

Sundance has also initiated an additional Phase 2 clinical trial of SUN-627 (EUCT 2026-525817-29-00) in Finland. 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, activated microglia, and reactive astrocytes.

“As a novel brain-penetrant TYK2 inhibitor, SUN-627 is a differentiated approach for the treatment of progressive forms of MS, targeting activated microglia and reactive astrocytes that are the hallmarks of the smoldering neuroinflammation that is a key factor linked to clinical progression in patients with progressive forms of MS,” said Chetan Gandhy, Executive Medical Director at Sundance Biosciences. “We are excited to be underway with this Phase 2 clinical trial to evaluate SUN-627’s ability to modulate key biomarkers in progressive forms of MS, which will provide us with critical insights into the potential to modify clinical progression in future clinical outcomes studies.”

About Progressive Forms of Multiple Sclerosis

Progressive forms of multiple sclerosis (MS), including primary progressive MS and non-active secondary progressive MS, are chronic neurodegenerative diseases characterized by a steady, gradual accumulation of neurological disability over. While the underlying biological causes of progressive forms of MS are not completely understood, on-going disability progression in patients with progressive forms of MS is closely associated with chronic active lesions that form in the brains of MS patients and never fully resolve. Activated microglia and reactive astrocytes are hallmark features of chronic active lesions and the surrounding normal appearing white matter and are believed to be key effector cells sustaining neuroinflammation and contributing to axonal injury and neurodegeneration. There is currently one approved therapy for primary progressive MS, ocrelizumab, which does not penetrate the blood-brain barrier and thus is largely unable to impact the brain-resident immune cells closely associated with continued clinical worsening. There are currently no approved therapies for non-active secondary progressive MS.

About SUN-627

SUN-627 is an internally discovered, potent, highly-selective, brain-penetrant oral allosteric TYK2 inhibitor with best-in-class potential being developed for neuroimmunology conditions, including progressive forms of multiple sclerosis (MS). Human genetics support TYK2 as a therapeutic target in MS through demonstration that a naturally occurring, partial loss-of-function genetic variant of TYK2 confers significant protection against the disease. SUN-627’s brain-penetrant TYK2 inhibition is designed to treat progressive forms of MS by dampening B cell and T cell signaling, astrocyte activation, and microglial activation behind the blood-brain barrier, resulting in downstream regulation of chemokines and cytokines that drive neuroinflammation. This broad inflammatory regulation has potential to provide significant benefit to patients with progressive forms of MS by directly impacting chronic neuroinflammation that is closely associated with disease progression. Brain-penetrant TYK2 inhibition also has broader therapeutic potential in additional neuroinflammatory conditions such as Alzheimer’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis (ALS).

About Sundance Biosciences

Sundance Biosciences is a clinical-stage biotechnology company dedicated to discovering and advancing next-generation therapies targeting tyrosine kinase 2 (TYK2), a non-receptor intracellular signaling kinase that plays an important role in regulating the immune system, to meaningfully impact the lives of individuals suffering from multiple sclerosis and other immune-mediated diseases. The Company’s two lead clinical programs are SUN-627, a brain-penetrant TYK2 inhibitor in Phase 2 development for progressive forms of MS, and SUN-111, a Phase 2-ready, peripherally-restricted TYK2 inhibitor for immune-mediated diseases. Sundance is led by a team of experienced drug developers and scientists and is backed by top healthcare investors. For more information, please visit www.sundancebio.com.

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The Yates Network LLC
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