PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706
PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706
The study is conducted to evaluate the efficacy, safety, and tolerability of two doses of
 K0706 compared to placebo in subjects with early Parkinson's Disease who are not receiving
 dopaminergic therapy.
Key inclusion Criteria:

 1. Diagnosed with "Clinically Probable PD" according to the MDS clinical diagnostic
 criteria, with documented onset of symptoms per treating physician's records within
 three years of the Screening visit. Disease severity according to modified Hoehn &
 Yahr stage ≤ 2;

 2. Projected to not require to start dopaminergic therapy within 9 months from Baseline;

 3. Female subjects must be not of childbearing potential, e.g., documented evidence that
 they are surgically sterile (e.g., hysterectomy, partial hysterectomy, bilateral
 oophorectomy, bilateral tubal ligation), or post-menopausal (at least 12 months since
 last menses) prior to Screening with serum Follicular Stimulating Hormone (FSH) ≥40
 mIU/mL).

 Key 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 the
 progression of PD. Treatment with Monoamine Oxidase B (MAOB) inhibitors will be
 allowed if the dose is stable for at least 30 days prior to Screening and subjects
 agree 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 nervous system disease affecting the subject's
 cognition or motor function at any time, such as another neurodegenerative disorder,
 multiple sclerosis or stroke. This does not include transient neurological deficits
 such as transient ischemic attacks or migraine aura;

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

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

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

 7. Any clinically significant cardiac abnormality in the opinion of the investigator.
 This would include myocardial infarction in the six months prior to screening, or
 significant ECG abnormality, including heart-rate corrected interval QT (QTc) based on
 Fridericia's correction formula > 470 milliseconds;

 8. Subject report of recent (6-month) illicit drug use (other than marijuana), or
 excessive intake of alcohol (as per investigator opinion);

 9. Subject report of marijuana use within one month of Screening or subject not willing
 to forgo marijuana use through the trial;

 10. Participation in other investigational drug trials within 30 days prior to Screening;

 11. Any concomitant medication or medication excluded that could put subject at risk, or
 interfere with study evaluations (Section 7.4);

 12. Recent use of medications that can cause Parkinsonism and suspicion of the
 investigator that it could have worsened the subject's Parkinsonism. This includes
 neuroleptics (e.g., olanzapine, risperidone, haloperidol), some anti-nausea
 medications (e.g., prochlorperizine, metoclopramide) and others (e.g., flunarizine,
 methyldopa);

 13. Use of medications that affect the dopamine system though do not cause or treat PD,
 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 them at a stable dose for over 60 days prior to Screening
 and plans to remain on them through the study;

 14. Any malignant disease other than basal cell carcinoma of the skin with evidence of
 disease within the past 5 years, or with the potential for recurrence;