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Sudo Biosciences Initiates Phase I Trial of Brain-Penetrant TYK2 Inhibitor SUDO-550 for Neuroinflammation

• Sudo Biosciences has commenced a Phase I clinical trial for SUDO-550, an orally administered allosteric TYK2 inhibitor targeting neuroinflammatory diseases. • The trial will evaluate the safety, tolerability, and pharmacokinetics of SUDO-550, with a focus on its ability to cross the blood-brain barrier in healthy volunteers. • SUDO-550 has demonstrated potential for brain penetration in preclinical studies, suggesting its utility in treating central nervous system diseases with neuroinflammation. • This trial marks Sudo Biosciences' second TYK2 inhibitor to enter clinical development this year, highlighting their focus on immune-mediated inflammatory conditions.

Sudo Biosciences, a biopharmaceutical company based in the US, has announced the initiation of a Phase I clinical trial for SUDO-550, a novel drug candidate aimed at treating neuroinflammatory diseases. The study is designed to assess the safety, tolerability, and pharmacokinetics of SUDO-550, including its capacity to penetrate the blood-brain barrier.

Trial Design and Objectives

The Phase I trial will involve the administration of single and multiple ascending doses of SUDO-550 to healthy volunteers. The primary objectives are to evaluate the drug's safety profile and to understand how it is absorbed, distributed, metabolized, and excreted by the body. A key focus will be on determining the extent to which SUDO-550 can cross the blood-brain barrier, a critical factor for treating central nervous system (CNS) diseases.

SUDO-550: A Selective TYK2 Inhibitor

SUDO-550 is an orally administered allosteric tyrosine kinase 2 (TYK2) inhibitor. It is designed to be highly selective and potent, minimizing off-target effects. TYK2 is a crucial mediator in cytokine signaling pathways associated with various immune-mediated inflammatory conditions. By inhibiting TYK2, SUDO-550 aims to modulate the inflammatory response in the brain and potentially alleviate symptoms of neuroinflammatory diseases.

Preclinical Evidence and Clinical Significance

Preclinical studies have indicated that SUDO-550 can penetrate the blood-brain barrier, a feature that is essential for treating CNS diseases characterized by compartmentalized neuroinflammation. According to Sudo Biosciences chief medical officer Ian Mills, this clinical trial is a critical step in establishing SUDO-550 as a "best-in-class brain-penetrant TYK2 inhibitor," and a therapy that could significantly advance the treatment of diseases such as multiple sclerosis, amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease.

Sudo Biosciences' Broader Pipeline

SUDO-550 is the second allosteric TYK2 inhibitor that Sudo Biosciences has advanced into clinical trials this year. SUDO-286, a topical treatment for psoriasis, is also currently undergoing two Phase I trials. This highlights the company's strategic focus on developing TYK2 inhibitors for a range of immune-mediated inflammatory conditions. Sudo Biosciences is based in Indiana and focuses on the TYK2 pseudokinase domain.

Financial Backing and Future Plans

In the past year, Sudo Biosciences completed a Series B financing round, raising $116 million jointly led by Enavate Sciences and TPG. This increased the company's total funding to $157 million since its establishment in 2020. The company plans to use these funds to advance its investigational TYK2 candidates further.
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Reference News

[1]
Sudo Biosciences begins trial of drug candidate for neuroinflammatory conditions
clinicaltrialsarena.com · Dec 3, 2024

Sudo Biosciences initiates Phase I trial of SUDO-550, an orally administered, highly selective TYK2 inhibitor for neuroi...

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