Press release

Sudo Biosciences Announces First Participants Dosed in Phase 1 Trial of Brain-Penetrant Allosteric TYK2 Inhibitor SUDO-550

• SUDO-550 is a potential best-in-class, orally administered, brain-penetrant TYK2 inhibitor being developed for the treatment of neuroinflammatory diseases.
• Phase 1 clinical trial supported by preclinical data demonstrating high potency, selectivity, and efficacy in preclinical models, along with the ability to cross the blood-brain barrier.

CARMEL, Ind. - December 2, 2024: Sudo Biosciences (“Sudo”), a biopharmaceutical company committed to designing and developing best-in-class precision TYK2 (tyrosine kinase 2) inhibitors, 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.

“Entering the clinic is a critical step in the development of SUDO-550 and establishing it as a best-in-class brain-penetrant TYK2 inhibitor. This is a therapy that could significantly advance the treatment of diseases such as multiple sclerosis, ALS and Alzheimer’s,” said Ian Mills, Chief Medical Officer, Sudo Biosciences. ”This is the second allosteric TYK2 inhibitor we have advanced into the clinic this year, after SUDO-286 which is progressing in two Phase 1 trials as a topical treatment for psoriasis.”

The company is developing multiple highly potent and selective small molecule TYK2 pseudokinase inhibitors designed to provide targeted treatments across a broad range of autoimmune and neurologic conditions.

About SUDO-550

SUDO-550 is an orally administered, allosteric TYK2 inhibitor that demonstrates high selectivity and potency for TYK2, minimizing off-target effects. Non-clinical studies have demonstrated excellent blood-brain barrier penetration with the compound, enabling therapeutic potential for CNS diseases characterized by compartmentalized neuroinflammation. These results support its potential as a best-in-class treatment for multiple neuroinflammatory diseases.

About SUDO-286

SUDO-286 is a highly potent, selective and potential first and best-in-class topical TYK2 inhibitor for psoriasis and other immune-mediated dermatologic diseases. The program entered the clinic earlier this year and is currently being evaluated in two Phase 1 studies in healthy volunteers and patients.

About Sudo Biosciences

Sudo Biosciences is a biopharmaceutical company committed to designing and developing novel medicines to transform patients’ lives. The company’s programs target the tyrosine kinase 2 (TYK2) pseudokinase domain. TYK2 is a key mediator in cytokine signaling pathways that have been linked to a broad range of immune-mediated inflammatory conditions. The company’s pipeline of next generation TYK2 inhibitors includes a potential first- and best-in-class brain-penetrant candidate for the treatment of multiple sclerosis and neurodegenerative diseases with underlying neuroinflammation and a potential first- and best-in-class topical candidate for immune-mediated dermatologic diseases. Sudo Biosciences is based in Carmel, IN, with operations across the US and UK. For more information, visit www.sudobio.com.

Media Contact

Kimberly Ha
KKH Advisors
917-291-5744
Kimberly.ha@kkhadvisors.com