A Phase 2a Study of the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis

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• Presence of the following: • Acute severe UC, defined by ≥6 bloody diarrhea/day and any signs of systemic toxicity (pulse >90 beats/min, temperature >37.8 °C, hemoglobin <105 g/L, erythrocyte sedimentation rate >30 mm/h, or C-reactive protein [CRP] >30 mg/L); or in the Investigator’s opinion, hospitalization for the treatment of UC may be imminent. • Previous extensive colonic resection (subtotal or total colectomy). • Short bowel syndrome. • Ileostomy, colostomy, ileoanal pouch, fistulae, or known fixed symptomatic stenosis of the intestine. • Toxic megacolon.
• Hypersensitivity or allergy to OD 07656, or any of its excipients
• Received any of the following: •Cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 56 days prior to Day 1. • IV corticosteroids within 14 days prior to Day 1. • Any biologic therapy (e.g., anti-tumor necrosis factors, anti-integrins, anti-interleukins) within 56 days or 5 half lives (whichever is greater) or within 28 days for participants without detectable drug levels prior to Day 1. • JAK inhibitors (e.g., tofacitinib, filgotinib, or upadacitinib) within 28 days prior to Day 1. • S1P modulators (i.e., ozanimod or etrasimod) within 28 days prior to Day 1. • IV antibiotics within 56 days prior to Day 1 or expected to receive IV antibiotics during the study. • NSAIDs as long-term treatment, defined as use for at least 4 days a week consistently each week over a period of at least a month (or acetaminophen >1000 mg daily and aspirin >325 mg daily). • Vaccination with a live or live-attenuated vaccine within 28 days prior to Day 1 or during the study. NOTE: It is recommended that participants be up to date for recommended inactivated, toxoid, or biosynthetic vaccines, such as injectable, coronavirus disease of 2019 (COVID 19), influenza, pneumococcal, and pertussis vaccine. • Fecal microbiota transplant (includes human microbiota-based therapeutics) within 28 days prior to Day 1. • Oral or injectable anticoagulants including but not limited to warfarin, heparin or heparinoids (i.e., enoxaparin), or direct acting anticoagulants such as Factor Xa inhibitors (i.e., apixaban, fondaparinux, and rivaroxaban) within 14 days prior to Day 1. • Oral corticosteroids: any doses >20 mg/day prednisone within the last 28 days, or for doses ≤20 mg/day prednisone, has not been on a stable dose for ≥28 days prior to Day 1. • Oral budesonide dose >9 mg/day within the last 28 days, or for doses ≤9 mg/day, has not been on a stable dose for ≥28 days prior to Day 1. • Oral 5-aminosalicylic acid drugs or sulfasalazine: any doses >4.8 g/day within the last 28 days or for doses ≤4.8 g/day, has not been on a stable dose for ≥28 days prior to Day 1. • Purine analogues (e.g., AZA, 6-MP, thioguanine) or MTX have been discontinued within 28 days prior to Day 1.
• Laboratory results that meet the following limits: Parameter Exclusion AST or ALT >2 × ULN eGFR <30 mL/min/1.73 m2 (by MDRD or by Schwartz a) WBC <2500/μL (<2.5 GI/L) ANC <1200/μL (<1.2 GI/L) Platelet count <100,000/μL (<100 GI/L) Absolute lymphocyte count <750/μL (<0.75 GI/L) Hemoglobin <9 g/dL (<90 g/L) Abbreviations: ALT, alanine aminotransferase; ANC, absolute neutrophil count; AST, aspartate aminotransferase; eGFR, estimated glomerular filtration rate; MDRD, Modification of Diet in Renal Disease; ULN, upper limit of normal; WBC, white blood cell. a eGFR will be calculated using the MDRD equation for participants ≥18 years old. The Schwartz equation will be used for participants <18 years old.
• Concurrent or previous participation in another clinical trial and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Day 1
• Any major surgery, in the Investigator’s opinion, performed within 8 weeks prior to Day 1 or planned during the study (i.e., any surgical procedure requiring general anesthesia).