A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke

Key Inclusion Criteria:

• Able to initiate study intervention within 25 hours of stroke onset

• Cohort A: Determined by the investigator to not be eligible for systemicthrombolysis and/or mechanical recanalization therapy (that is, mechanicalthrombectomy, local fibrinolytic therapy as per local standard of care) for thecurrent stroke.

• Cohort B: Determined by the investigator to be eligible for systemic thrombolysisand/or mechanical recanalization therapy (that is, mechanical thrombectomy, localfibrinolytic therapy as per local standard of care) for the current stroke.

• Cohort A: If a participant is not eligible for systemic thrombolysis and/ormechanical recanalization therapy, screening and baseline NIHSS score of 6 to 22 isrequired (inclusive) and must be stable, defined as absence of an increase ordecrease of ≥4 points within ≥1 hour to ≤3 hours of screening, and NIHSS scoreshould be 6 to 22 at baseline.

• Cohort B: In a participant who is eligible to receive or has received concomitantsystemic thrombolysis and/or mechanical recanalization therapy, the NIHSS score mustbe 6 to 22 at screening prior to systemic thrombolysis and/or mechanicalrecanalization therapy and the second/baseline NIHSS score must be 6 to 22 andshould be done after systemic thrombolysis and/or mechanical recanalization therapy.

• Medically stable at the time of enrollment except for primary disease andcomplications associated with it, according to the judgment of the investigator. Inaddition, hospitalization during the Follow-up Period is not anticipated, and theparticipant appears likely to be able to complete the study. Medically stable isdefined as disease not requiring significant change in therapy for 3 monthsfollowing enrollment.

Key Exclusion Criteria:

• Any disease or neurological disorder that, in the opinion of the investigator, wouldinterfere with the conduct of the study

• A severe decrease in consciousness level (defined as NIHSS item 1a score 3: Notalert, responds only with reflex motor or autonomic effects, or totallyunresponsive, flaccid, and areflexic)

• Disability corresponding to a mRS score of ≥2 before the onset of stroke

• A history of stroke (excluding transient ischemic attack), history of or currentintracranial hemorrhage, or head trauma that caused neurological effects within 90days prior to obtaining informed consent

• Participants with an ischemic stroke in cerebellum and/or brain stem as the maininfarction site

• Diagnosis of a current transient ischemic attack

• Unable to undergo either computed tomography or magnetic resonance imaging

• Considered by the investigator to be inappropriate to participate due to a historyor complication of serious cardiovascular disease within 1 month of screening (forexample, history of acute myocardial infarction, current acute myocardialinfarction, uncontrollable heart failure, infective endocarditis requiringtreatment, or acute aortic dissection, or requiring or likely to requirehospitalization for severe arrhythmia during the study)

• Blood glucose level <50 or >400 milligrams/deciliter after glycemic control

• Systolic blood pressure ≥220 millimeters of mercury (mmHg) or diastolic bloodpressure ≥120 mmHg after antihypertensive treatment

• Sensitivity to any of the study interventions, or components thereof, or clinicallysignificant drug or other severe allergy that, in the opinion of the investigator,contraindicates participation in the study

• Use of prohibited concomitant medications or therapies listed in the protocol forthe treatment of current AIS

• Participants who have previously received redasemtide

• Participants who have received any investigational product within 90 days ofscreening

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.