Sudo bags $116M to take TYK2 to new heights

20 Dec 2023
firstwordpharma.com
Phase 2Drug Approval
Sudo Biosciences is carving out an anti-inflammatory niche for itself with a fresh $116 million and a portfolio of TYK2 inhibitorsTYK2 inhibitors that could be safer than current autoimmune treatments, while also reaching the ripe neurodegenerative space.
The series B funds will enable Sudo to bring two candidates to the clinic in 2024: an oral candidate for multiple sclerosis, and a topical psoriasis candidate to take on Bristol Myers Squibb’s Sotyktu, the first TYK2 inhibitorTYK2 inhibitor to earn FDA approval.
Part of the JAK family, TYK2 has become an attractive target for a range of inflammation-mediated conditions, including autoimmune and neurodegenerative diseases, thanks to its promising safety profile. According to Sudo CEO Scott Byrd, traditional JAK inhibition can have poorly selective binding due to the nearly identical kinase domain structures shared among JAKs, which in turn can lead to safety issues. Several approved JAK inhibitorsJAK inhibitors carry warnings for serious heart-related events, cancer, and blood clots.
Sudo’s portfolio of TYK2 inhibitorsTYK2 inhibitors are designed to be more selective and avoid the safety concerns that have plagued JAK inhibitorsJAK inhibitors.
“The lack of safety liabilities associated with JAK1 and JAK2 inhibition mean that higher doses and therefore greater degrees of TYK2 inhibition can be achieved, which is expected to lead to higher efficacy in some diseases,” Byrd told FirstWord.
Wednesday’s round brings Sudo’s total funding to $157 million. The series B was co-led by Enavate Sciences and TPG, with participation from Sanofi Ventures; Sudo’s $37-million series A in 2022 was led by Frazier Life Sciences and Velosity Capital.
TYK2 heats up
BMS cracked open the space in 2022 with the approval of Sotyktu (deucravacitinib), an oral TYK2 inhibitorTYK2 inhibitor to treat psoriasis. Since then, other companies have begun developing candidates in the proven autoimmune space – where Sotyktu now stands as the efficacy benchmark for an oral psoriasis medication – or exploring the target in other disease areas.
Takeda will most likely be the first to go toe-to-toe with Sotyktu. The Japanese pharma unveiled Phase II data this year for its oral TYK2 inhibitorTYK2 inhibitor TAK-279, demonstrating improved efficacy over Sotkytu when comparing complete resolution of disease.
Rather than competing with oral TYK2 inhibitorsTYK2 inhibitors, Sudo is developing a topical candidate for psoriasis, which may reach a larger share of patients. Byrd estimated that up to 90% of psoriasis patients are treated with topical therapies. SUDO-286 is expected to enter the clinic next year.
TYK2 inhibition is also attracting investments outside the autoimmune space. Biohaven, a Pfizer spin-off, plans to start in 2024 a Phase II trial of dual TYK2/JAK1 inhibitor BHV-8000 to treat Parkinson’s disease (PD). Biohaven acquired ex-China exclusive rights to the candidate from Hangzhou Highlightll Pharmaceutical, which stands to receive up to $950 million in milestones.
Biohaven CEO Vlad Coric told FirstWord in March that while inflammation is known to play a crucial role in the pathogenesis of neurodegenerative conditions like PD and Alzheimer’s disease (AD), no group has been able to successfully test the theory that tamping down the immune response could slow or even halt their progression.
Sudo sees the potential for TYK2 inhibition to treat neurodegenerative diseases because of how it can modulate microglia.
“Microglia are believed to be key contributors to neurodegenerative pathology, in diseases such as Alzheimer’s and ALS, as well as in progressive MS,” Sudo CMO Ian Mills told FirstWord. “Targeting microglia is complex, since they fulfil important homeostatic housekeeping roles as well as mediating components of the adverse neuroinflammatory response. We believe that targeting TYK2 in the brain will selectively inhibit the latter, while preserving the former.”
Sudo plans to bring its brain-penetrant oral candidate, SUDO-550, into the clinic next year for multiple sclerosis, and the company is also exploring its potential in AD and amyotrophic lateral sclerosis (ALS).
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