VENT-02 / Ventus Therap - LARVOL DELTA

A Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease (clinicaltrials.gov) - P1/2 | N=29 | Terminated | Sponsor: Ventus Therapeutics U.S., Inc. | Recruiting ➔ Terminated; Sponsor decision

Trial termination • CNS Disorders • Movement Disorders • Parkinson's Disease

Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of Vent-02, a Novel CNS-Penetrant NLRP3 Inhibitor for the Treatment of Parkinson's Disease (MDS Congress 2025) - "Vent-02 is safe and generally well-tolerated and has a favorable PK and pharmacodynamic profile in healthy volunteers. The activity of vent-02 in mild to moderate Parkinson's Disease patients will be assessed in a Phase 1b study."

Clinical • PK/PD data • CNS Disorders • Movement Disorders • Parkinson's Disease • CRP • IL18 • IL1B • IL6 • NLRP3

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the NLRP3 Inhibitor Vent-02 in Patients with Mild to Moderate Parkinson's Disease (MDS Congress 2025) - "We expect to demonstrate that NLRP3 inhibition has the potential to be disease-modifying. The intention of DHT assessments is to also provide evidence of early symptomatic effects of NLRP3 inhibition with vent-02."

Clinical • P2 data • CNS Disorders • Movement Disorders • Parkinson's Disease • NLRP3

Ventus Therapeutics Announces Publication in Nature’s Communications Chemistry Describing the Structure-based Optimization of a New Series of cGAS Inhibitors (Businesswire) - "The publication provides insights into the mechanism of action and binding mode of known cGAS inhibitors, including the identification of key structural differences driving potency shifts between species. Investigators leveraged these findings to inform a structure-based design approach, which they used to develop a novel, highly potent cGAS inhibitor. This work provides the framework for rational and efficient optimization of cGAS inhibitors and potential preclinical translational strategies, adding to Ventus’ growing body of research on cGAS biology....'We will commence our first Phase 2 trial for VENT-03 in patients with lupus in 2025 and are planning additional trials given the strong biological evidence supporting the role of cGAS in the pathogenesis of multiple diseases.'...VENT-02 is a best-in-class, brain-penetrant, oral NLRP3 inhibitor....is expected to enter Phase 2 development in osteoarthritis in obese patients later in 2025."

New P2 trial • Preclinical • Lupus • Osteoarthritis

Ventus Therapeutics Announces First Patient Dosed in Phase 2a Clinical Trial Evaluating VENT-02, an Oral, Brain-Penetrant NLRP3 Inhibitor, in Parkinson’s Disease (Businesswire) - "Ventus Therapeutics...today announced that the first patient has been dosed in a Phase 2a trial of VENT-02 in patients with mild to moderate Parkinson’s disease. VENT-02 is a novel, oral, brain-penetrant inhibitor of NLRP3, a key driver of inflammation and component of the innate immune system that plays a critical role in a wide range of inflammatory diseases...Topline data from the Phase 2a trial are expected in late 2025 or early 2026."

P2a data • Trial status • Parkinson's Disease

A Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients with Mild to Moderate Parkinson's Disease (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Ventus Therapeutics U.S., Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

A Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients with Mild to Moderate Parkinson's Disease (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Ventus Therapeutics U.S., Inc.

New P1/2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Ventus Therapeutics Announces Results from Phase 1 Clinical Trial of VENT-02, a Novel, Orally Administered, Brain-Penetrant NLRP3 Inhibitor (Businesswire) - P1 | N=NA | "Ventus Therapeutics...announced results from its Phase 1 clinical trial of VENT-02, a novel, oral, brain-penetrant NLRP3 inhibitor....In this Phase 1 clinical trial, VENT-02 was well-tolerated, with no dose-limiting toxicities or serious adverse events reported and only mild or moderate treatment-related adverse events observed. The moderate adverse events included headache and nausea and were only observed at a dose multiple times higher than the intended therapeutic doses....Ventus expects to initiate a Phase 1b trial of VENT-02 in patients with Parkinson’s disease in the second half of 2024 and a Phase 2 trial in patients with treatment-refractory epilepsy in 2025."

New P1 trial • New P2 trial • P1 data • CNS Disorders • Epilepsy • Parkinson's Disease