Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)

Phase 2

Recruiting

Brief Summary: This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH).

Detailed Description: This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH).

This study will monitor exploratory radiographic and clinical endpoints, explore the use of biochemical biomarkers to demonstrate target engagement and biological response to a potential new therapy targeted to neuroinflammation and synaptic dysfunction mechanisms.

MW189 is a novel small molecule drug candidate developed as a selective suppressor of disease-and injury-induced proinflammatory cytokine overproduction associated with destructive neuroinflammation/synaptic dysfunction cycles. In animal models of acute brain injuries such as ICH and Traumatic Brain Injury (TBI), MW189 attenuates neuroinflammation, reduces cerebral edema, and improves functional and cognitive performance. The investigators seek to establish if these targets are modified in humans with ICH.

Recruitment & Eligibility

Inclusion Criteria

Confirmed diagnosis of spontaneous, non-traumatic ICH.
10 mL ≤ ICH ≤ 60 mL (confirmed via diagnostic and stability CT scans utilizing volumetric assessment)
Participants receiving anticoagulants are eligible upon reversal and stability within 24hrs after onset of ICH symptoms
Age ≥ 18 years
Able to receive first dose of test article ≤ 24h after onset of ICH symptoms
NIHSS score ≥ 2 at randomization or Glasgow Coma Scale ≥ 5 at randomization
Controlled blood pressure (systolic BP < 180 mm Hg) at randomization.
Premorbid magnetic resonance spectroscopy (mRS) of 0-2
Has adequate venous access
No planned surgical intervention except EVD
Written informed consent from the patient or legally authorized representative (LAR)

Exclusion Criteria

Unstable hematoma defined as > 6 mL increase as compared to previous CT volume taken at least 6 hours apart within 24 hrs after onset of ICH symptoms.
Anticipated neurosurgical evacuation by open surgery or minimally invasive surgery with or without Alteplase (EVD allowed).
Uncontrolled temp >38.5˚C at enrollment.
Signs of intracranial infection or emergence of a systemic infection
Is pregnant or lactating
Signs of liver and kidney chronic disease (i.e. creatinine >2, bilirubin > 3, receiving dialysis)
Non-reversible bleeding diathesis
Used any chronic immunosuppressants or chronic anti-inflammatory drugs (excluding low-dose aspirin), by any route of administration within the past 7 days.
Anticipated withdrawal of life-sustaining therapies within the first week after admission.
In the opinion of the investigator, patient has any contraindication to the planned study assessments.
In the opinion of the investigator, patient has a condition that could interfere with the proposed treatment or unacceptably increase the individual's risk by participating in the study.
Concomitant enrollment in another acute interventional study

Arm && Interventions

Group	Intervention	Description
Experimental	MW189	MW189 (0.25 mg/kg) is administered within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)
Control	Saline	Administration of saline within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)

Primary Outcome Measures

Name	Time	Method
Difference in the proportion of all cause-morality between arms	7 days post-randomization	Assess the safety and tolerability of MW189 for patients as determined by the rate of death during the treatment period.

Secondary Outcome Measures

Name	Time	Method

Locations (11): New York University Grossman School of Medicine
🇺🇸
Brooklyn, New York, United States
University of Alabama Birmingham
🇺🇸
Birmingham, Alabama, United States
Johns Hopkins Hospital
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Baltimore, Maryland, United States
University of Cincinnati
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Cincinnati, Ohio, United States
University of Texas Houston
🇺🇸
Houston, Texas, United States
University of Kentucky
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Lexington, Kentucky, United States
Yale New Haven Hospital
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New Haven, Connecticut, United States
University of New Mexico
🇺🇸
Albuquerque, New Mexico, United States
Stanford University
🇺🇸
Palo Alto, California, United States
Cleveland Clinic Florida
🇺🇸
Stuart, Florida, United States
University of Texas San Antonio
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San Antonio, Texas, United States