PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706

Part 1:

Inclusion criteria:

1. Males or females aged ≥ 50 years;

2. Body mass index (BMI) greater than 18.5 kg/m2 and less than 45 kg/m2;

3. Diagnosed with "Clinically Probable PD" according to the MDS clinical diagnosticcriteria, with documented diagnosis of PD per treating physician's records withinthree years of the Screening visit. Disease severity according to modified Hoehn &Yahr stage ≤ 2;

4. Projected to not required to start dopaminergic therapy within 9 months fromBaseline;

Exclusion criteria:

1. Current, or within 60 days of Screening, use of any prescription, investigational,or over the counter medication for the symptomatic treatment of PD or to slow theprogression of PD. Treatment with Monoamine Oxidase B (MAOB) inhibitors will beallowed if the dose is stable for at least 30 days prior to Screening and subjectsagree to remain on it for the duration of the study;

2. Prior use of dopaminergic therapy (e.g., levodopa, dopamine agonist, amantadine) for 30 or more days any time in the past;

3. A diagnosis of a significant central or peripheral nervous system disease affectingthe subject's cognition or motor function at any time, such as anotherneurodegenerative disorder, multiple sclerosis or stroke. This does not includetransient neurological deficits such as transient ischemic attacks or migraine aura;

4. A diagnosis of a medical condition that could interfere with interpretation of theMDS-UPDRS during the trial (e.g., musculoskeletal disorders);

5. Contraindications to receiving an MRI;

6. Contraindications to receiving a DaT SPECT scan (e.g., hypersensitivity to theactive substance, any of the excipients, or iodine) if a new DaT SPECT scan isrequired for the study;

7. Most recent DaT SPECT scan not compatible with PD (i.e., Scans Without Evidence ofDopaminergic Deficit [SWEDD]) based on a central reading by a study physician;

8. MRI of the brain performed after onset of PD suggestive of secondary Parkinsonism (e.g., subdural hematoma, normal pressure hydrocephalus, or infarcts of the basalganglia);

9. Severe tremors as defined by a score of "severe" on any of the MDS-UPDRS Parts 2 or 3 tremor severity (not constancy) items;

10. Montreal cognitive assessment score < 25

11. History of any surgery on the brain itself including deep brain stimulation for PD (note this does not include surgeries on the skull that do not affect the brain,e.g., small meningioma removal);

12. History of hypersensitivity (e.g., bronchospasm, anaphylaxis, serious drug rash) tocontents of the study drug or other tyrosine kinase inhibitors;

13. Recent use of medications that can cause Parkinsonism and suspicion of theinvestigator that it could have worsened the subject's Parkinsonism. This includesneuroleptics (e.g., olanzapine, risperidone, haloperidol), some anti-nauseamedications (e.g., prochlorperizine, metoclopramide) and others (e.g., flunarizine,methyldopa)

14. Use of medications that affect the dopaminergic system within 60 days of Screening.This includes stimulants (e.g., methylphenidate, amphetamine derivatives, modafinil)and Monoamine Oxidase A (MAOA) inhibitors (e.g., phenelzine, and tranylcypromine).Note that antidepressants are acceptable as long as the subject has remained on themat a stable dose for over 60 days prior to Screening and plans to remain on themthrough the study;

15. Any malignant disease (other than basal cell carcinoma of the skin) with evidence ofdisease within the past 5 years and with the potential for recurrence

Part 2:

Inclusion criteria:

1. Subject has completed part 1 of the study.

2. Subject projected not to need dopaminergic treatment except for treatment withMonoamine Oxidase B (MAOB) inhibitors. MAOB inhibitors will be allowed if thepatient was already taking the same during part 1 of the study.

3. Subject has received K0706/placebo, as appropriate, within 4 weeks prior to end ofpart 1 of the study.

4. Male subjects enrolled in the study should not father a child and are advised toprevent the passage of semen to their sexual partner during intercourse using aneffective method, as judged by the Investigator, for the duration of the study andfor 3 months after the last dose of study drug

Exclusion criteria:

1. Clinically significant or unstable psychiatric or medical condition, vital sign, orlaboratory abnormality that in the opinion of the investigator interferes withparticipation in the study

2. Any condition that in the opinion of the Investigator represents an obstacle forstudy conduct and/or represents a potential unacceptable risk for the subject.

3. Subject has any concurrent medical condition or uncontrolled, clinically significantsystemic disease (e.g., renal failure, heart failure, hypertension, liver disease,diabetes, or anemia) that, in the opinion of the Investigator, could cause continuedtreatment to be detrimental to the subject