A Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease

Inclusion Criteria:

• 45 to 90 years of age, inclusive.

• Body weight and body mass index (BMI) within the range of 100 to 265 pounds (45 to 120 kg) and 18 to 34 kg/m2 (inclusive), respectively.

• A diagnosis of idiopathic PD according to United Kingdom (UK) Brain Bank or MovementDisorder Society (MDS) criteria with bradykinesia and ≥ 1 additional cardinal signof PD (e.g., resting tremor, rigidity).

• A diagnosis of PD for ≤ 7 years at Screening.

• A modified Hoehn & Yahr stage 1 to 2.5.

• If presently receiving treatment for PD, must be on a stable dose for ≥ 2 weeksprior to dosing, with no expected change in this regimen for the duration of thestudy.

• If presently taking any non-PD concomitant medications, must be on a stable dose for ≥ 2 weeks prior to dosing.

Exclusion Criteria:

• Any clinically significant abnormality at Screening

• A positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virusantibody (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV) 1/2 atScreening.

• A significant neurological disease affecting the central nervous system, other thanPD, that may affect cognition or ability to complete the study, including but notlimited to dementias, severe and repetitive past (up to 5 years) head trauma, normalpressure hydrocephalus, or epilepsy or recurrent seizures (except febrile childhoodseizures), as determined by the investigator.

• Current serious or unstable illnesses, that, in the investigator's opinion, couldcompromise patient safety and ability to comply with study procedures, or has a lifeexpectancy of < 24 months.

• A history of suicidal ideation or previous suicide attempt in the 12 months prior toScreening or is clinically judged by the investigator to be at serious risk forsuicide as assessed by medical history, examination, or the C-SSRS.

• A contraindication (e.g., current use of anticoagulants) that would prohibit alumbar puncture (LP).

• Currently enrolled in any other interventional clinical trial involving aninvestigational product or any other type of medical research judged not to bescientifically or medically compatible with this study, as assessed by theinvestigator.

• Has participated in a clinical trial involving an investigational product within 30days or 5 half-lives (whichever is longer) prior to dosing.

• Has levodopa-induced dyskinesias lasting for > 25% of waking day or dyskinesiasinterfering with many daily activities.

• Has dysphagia to the extent that it would affect the patient's ability to swallowthe investigational medicinal product (IMP).

• Has a parkinsonian syndrome, including atypical parkinsonism.

• Is a known carrier (i.e., confirmed by historical medical documentation) of familialPD genes.