Phase 2 Study to Assess Efficacy & Safety of WP1302 Prevent Relapse of MMI w/Draw in Subj. w/ Graves' dz

Exclusion Criteria

• •1. Currently using biotin supplements.
• •2. Known history of allergy to the ingredients of WP1302, or hypersensitivity reaction that in the opinion of the investigator would exclude the subject's participation in the study.
• •3. Previous treatment with radioiodine or (partial or complete) thyroidectomy.
• •4. Subjects with known pituitary disease, such as traumatic brain disease, hyperprolactinemia, and hypophysitis.
• •5. Treatment with steroids (administered via the oral and/or parenteral routes) within 3 months prior to baseline or requiring intermittent use of systemic steroids for disease management (such as severe asthma), inhaled steroids are not prohibited.
• •6. History of hyperthyroidism not caused by Graves' disease (e.g., toxic multinodular goiter, autonomous thyroid nodule, or acute inflammatory thyroiditis).
• •7. Subjects who may have thyroid nodules that require alternative intervention.
• •8. Symptoms and signs of thyroid storm such as fever, profuse sweating, vomiting, diarrhea, delirium, severe weakness, seizures, markedly irregular heartbeat, yellow skin and eyes (jaundice), severe low blood pressure, and coma, pyrexia with no other cause than hyperthyroidism.
• •9. Subjects who have a history of intolerance or contraindication to the use of beta-blockers.
• •10. Subjects with history of arrhythmia, or cardiovascular accident, or other cardiovascular disease who maybe at increased risk of cardiac adverse events from treatment or recurrence of hyperthyroidism.
• •11. Subjects with history of cerebrovascular accident/transient ischemic attack, or other cerebrovascular disease who maybe at increased risk of neurologic adverse events from treatment or recurrence of hyperthyroidism.
• •12. Prior treatment with immunotherapies (including rituximab), any cytokine or anti-cytokine therapy.
• •13. Prior treatment with immunomodulatory drugs, such as cyclosporine A, methotrexate, and/or cyclophosphamide.
• •14. Prior use of disease-related T cell-inducing therapy or peptide-tolerizing agent to treat Graves' disease.
• •15. Inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase \> 3 times the upper limits of the normal (ULN) at screening.
• •16. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2, calculated as individual eGFR derived from Modification of Diet in Renal Disease formula.
• •17. Receiving hemodialysis or peritoneal dialysis or microdialysis or continuous venovenous hemofiltration or continuous venovenous hemodialysis.
• •18. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• •19. Known history of active or chronic infectious disease or any disease which compromises immune function (e.g., HIV+, HTLV-1, active Lyme disease, latent or active TB, viral hepatitis).
• •20. Major surgery within 6 months prior to the screening visit or requiring ongoing active treatment after surgery irrespective of the time since surgery.
• •21. Active thyroid eye disease (clinical activity score \[CAS\] ≥3) with functional visual impairment sufficient to cause poor quality of life, or dysthyroid optic neuropathy likely to require immunosuppressive treatment during the 30 weeks of the study.
• •22. Any vaccination within 30 days prior to screening, except for influenza and coronavirus vaccines.
• •23. Being pregnant, breastfeeding, or planning to become pregnant during the study.
• •24. Documented presence of immunodeficiency or an immunocompromised condition including hematologic malignancy, bone marrow transplant, or known human immunodeficiency virus infection with a CD4 count \<200/mm3.
• •25. Currently actively moderate-heavy using tobacco (≥10 cigarettes a day).
• •26. Participating in any clinical study of any investigational medication (i.e., unauthorized medication) within 90 days prior to randomization.
• •27. Any other significant medical illness or psychiatric conditions that in the opinion of the investigator, would preclude participation in the study or impair the ability to give informed consent; any other clinically apparent autoimmune disease currently requiring disease-modifying or anti-inflammatory treatment; or significant illness which has not resolved within 4 weeks prior to the planned date of first dose of WP1302.
• •28. Any other conditions or prior therapies, which, in the opinion of the investigator, would make the subject unsuitable for this study.