Ventyx Biosciences Announces Initiation of Dosing in a Phase 2a Study of VTX3232 in Patients with Early Parkinson's Disease Page 1

Results of this study are expected in 2025

SAN DIEGO, Sept. 6, 2024 (GLOBE NEWSWIRE) — Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies to treat a broad range of inflammatory diseases with significant unmet medical needs, today announced that the first patient has been dosed in a Phase 2a study of VTX3232 in patients with early-stage Parkinson's disease.

“We are excited to begin this study of VTX3232 in patients with early-stage Parkinson's disease,” said Mark Forman, MD, PhD, Chief Medical Officer. “There is a compelling body of evidence from the literature suggesting a strong mechanistic rationale for targeting NLRP3-driven neuroinflammation in Parkinson's disease and suggesting that microglial NLRP3 activation may play an important role in Parkinson's pathogenesis and neurodegeneration. This study will examine the effects of VTX3232 on disease- and target-relevant biomarkers and will also include exploratory PET neuroimaging to measure the effects of VTX3232 on microglial activation. These measurements may provide initial insights into the potential of VTX3232 to disrupt Parkinson's disease pathology through NLRP3 inhibition in the CNS.”

The Phase 2a study of VTX3232 in early Parkinson's disease is expected to enroll approximately ten patients for a 28-day open-label treatment phase. The primary endpoint of the study is safety and tolerability. Other outcome measures include pharmacokinetics and relevant biomarkers in plasma and cerebrospinal fluid. We expect to be able to present the top-line results of this study in 2025.

About VTX3232

VTX3232 is an oral, selective, CNS-penetrating NLRP3 inhibitor with potential therapeutic benefit for a range of neuroinflammatory and neurodegenerative diseases, including Parkinson's disease, cardiometabolic disease, Alzheimer's disease and multiple sclerosis. In the first quarter of this year, we announced results from a Phase 1 study of VTX3232 in healthy adult subjects, where steady-state exposures achieved with a once-daily dose of VTX3232 exceeded the IC of interleukin-1β (IL-1β).₉₀ in both plasma and cerebrospinal fluid over 24 hours. We believe these data support the potential of VTX3232 to establish itself as a best-in-class CNS-penetrating NLRP3 inhibitor for the treatment of neuroinflammatory diseases.