BEACH: Biomarker and Edema Attenuation in IntraCerebral Hemorrhage Phase 2a Trial

Exhibit # BEACH TRIAL STATEMENT OF WORK Project Title: Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) Phase 2a trial Primary Site PIs: Dr. Dan Hanley; Dr. Linda Van Eldik Primary Site Institution: Johns Hopkins University Subaward Site PI: Subaward Site Institution: Project start/end date: February 15, 2021 – November 30, 2025 Project 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. We seek to establish if these targets are modified in humans with ICH. The subrecipient agrees to maintain a clinical site for the BEACH trial with the appropriate staff and facilities to conduct the trial. The subrecipient will have the experience, capability and resources, including but not limited to sufficient trained personnel and equipment, to efficiently and expeditiously perform the study as described in the Protocol in a professional and competent manner. The subrecipient will: • Activate the BEACH trial within 90 days of receipt of trial materials. • Maintain weekly check-ins with the sponsor site manager to review work progress throughout the duration of the trial. • Maintain daily recruitment logs of all subjects screened with the diagnosis of study interest. • Upload informed consent forms into the study repository for remote monitoring or otherwise make informed consent forms reviewable remotely. • Consent and enroll patients according to the protocol and in keeping with good clinical practices. • Provide current regulatory documents and oversee an up-to-date delegation of authority log. • Provide training certifications and a local training log of all current study personnel and all new team members that join throughout the trial. • Enter randomization data in real time and upload treatment phase images and outcomes data daily. • Complete case report forms within 48 hours of events and visits. • Prepare unexpected safety event data within 24 hours of discovery • Contact patients regularly during follow-up to maintain communication and complete all follow-up visits within the designated time windows and report if a patient withdraws prematurely. • Resolve queries within 5 days of posting. • Attend monthly all-site information webinars. • Adhere to the schedule of activities and study timelines • Inform their institution of trial completion and provide final reports and documents to the Johns Hopkins University Coordinating Center for proper closeout of the study.