Ventyx's Phase 2a Trial Of VTX3232 Meets Primary Goal In Early-Stage Parkinson's Disease

(RTTNews) - Ventyx Biosciences, Inc. (VTYX) announced Tuesday positive top-line results from its Phase 2a study of VTX3232, a novel, CNS-penetrant NLRP3 inhibitor, in patients with early-stage Parkinsons disease. The study met its primary goal of establishing safety and tolerability of VTX3232 in such patients.

The company noted that these data meet its internal criteria for continued clinical development in Parkinsons disease. Ventyx's planning for a double blind, placebo-controlled, dose ranging Phase 2 trial in Parkinsons disease, and potentially in additional neurodegenerative disorders such as Alzheimers disease, is underway.

The clinical-stage biotech company developing oral therapies for autoimmune, inflammatory and neurodegenerative diseases noted that the Phase 2a trial met the primary objective of demonstrating safety and tolerability, with no drug-related treatment-emergent adverse events or TEAEs observed throughout the dosing period.

The trial also met pharmacokinetic and pharmacodynamic endpoints, showing high drug exposures in plasma and cerebral spinal fluid or CSF as well as clear evidence of target engagement in plasma and CSF, with potent suppression of NLRP3-related biomarkers.

VTX3232 is a CNS-penetrant, potent and selective inhibitor of the NLRP3 inflammasome.

The single-center, open-label Phase 2a study evaluated a 40mg oral daily dose of VTX3232 in ten patients with early-stage, idiopathic Parkinsons disease over a 28-day treatment period. The primary objective of the trial was to evaluate safety and tolerability.

Mark Forman, Chief Medical Officer, said, "We are thrilled that our Phase 2a data show that a once-daily dose of VTX3232 can safely maintain plasma and CSF levels above the IC90 for IL-1b for 24 hours in patients with early Parkinsons disease. In addition, we observed biomarker changes in CSF and plasma that reflect potent NLRP3 inhibition by VTX3232."

In the trial, VTX3232 was safe and well tolerated through the 28-day dosing period. All adverse events were mild or moderate in severity and assessed as unrelated to study treatment, and there were no serious adverse events reported.

Ventyx said it intends to present the complete dataset at a future medical meeting and to publish full results in a peer-reviewed medical journal.

For More Such Health News, visit rttnews.com