Abstract Body: The Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) (NCT05020535) phase 2a pilot study is a first-in-patient study to assess the safety and tolerability of MW189 in patients with intracerebral hemorrhage (ICH). BEACH is enrolling adult patients with stable spontaneous ICH within 24 hours of onset. This study will explore the use of biochemical biomarkers to demonstrate target engagement and biological response to a potential new therapy targeting neuroinflammation and synaptic dysfunction mechanisms. Exploratory outcomes include radiographic markers on CT and MRI as well as clinical and functional outcomes throughout follow-up.

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, MW189 attenuates neuroinflammation, reduces cerebral edema, and improves functional and cognitive performance. Promising suppression of IL-10 inflammatory response has been demonstrated in normal humans. We now seek to establish if these targets are modified in humans with ICH.

BEACH is a multicenter trial with 12 enrolling centers across the United States. BEACH aims to enroll 120 adults with a confirmed diagnosis of spontaneous, non-traumatic ICH. The primary objective of the clinical trial is to assess the safety and tolerability of MW189 administration through day 7. The pharmacokinetics of MW189 will be defined. Patients will be randomized within 24 hours to drug (0.25 mg/kg) or placebo in a 1:1 ratio (n=60/group) administered every 12 hours for up to 10 doses with follow-up at 30, 90, and 180 days. BEACH has been open to enrollment since August 2022. As of October 30, 2024, 60 participants have been enrolled.

The trial is led by Linda Van Eldik (University of Kentucky) and Daniel F. Hanley (Johns Hopkins University). The trial website provides further information https://biostraining.com/BEACH/. BEACH is funded by a grant from the National Institute on Aging (Grant: R01AG069930) with design and planning work through the Trial Innovation Network JHU Trial Innovation Center (Grant:U24TR004440).