Ability to nearly completely inhibit TYK2 pathway biomarkers positions SUN-627 as potential novel treatment for progressive forms of multiple sclerosis, according to Phase I data.

Sundance Biosciences’ brain-penetrant, oral allosteric tyrosine kinase 2 (TYK2) inhibitor has demonstrated best-in-class potential in new Phase I results.
The US-based biotechnology company is developing SUN-627 for neuroimmunology conditions, including progressive forms of multiple sclerosis (MS).
The data shows that a once-daily dose of SUN-627 enabled near complete (>90 percent) inhibition of the TYK2 pathway for 24 hours, as well as full central nervous system (CNS) penetration in healthy participants.
TYK2 is an enzyme that helps to regulate the immune system, so the ability to offer broad inflammatory regulation could provide significant benefit in progressive forms of MS. Specifically, by directly impacting chronic neuroinflammation that is closely associated with disease progression.
“We are excited to advance SUN-627 as a novel and potentially best-in-class treatment approach for progressive forms of MS, an area with significant unmet medical need. Our Phase I data support SUN-627 as a highly potent, selective, and brain-penetrant TYK2 inhibitor”
Andrew Yost, Chief Executive Officer of Sundance Biosciences
Andrew Yost, Chief Executive Officer of Sundance Biosciences, said: “The clinical and preclinical results from our studies to date give us confidence in our path forward with SUN-627. We are excited to advance SUN-627 as a novel and potentially best-in-class treatment approach for progressive forms of MS, an area with significant unmet medical need.
“Our Phase I data support SUN-627 as a highly potent, selective, and brain-penetrant TYK2 inhibitor. Our preclinical results support brain-penetrant TYK2 inhibition as a mechanism that is uniquely capable of addressing the neuroinflammation behind the blood-brain barrier that is a hallmark of progressive forms of MS and is not addressed by current standard of care.”
In addition to facilitating disease reversal, achieving brain-penetrant TYK2 inhibition reduces microglial and astrocytic activation and harmful downstream cytokines, chemokines and markers of neurodegeneration / de-myelination, according to the paper authors.
In February, Roche presented late-stage data for its oral Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib as a potential first-in-class multiple sclerosis therapy.



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