Phase 2 Mild-to-Moderate COVID-19 Study Results for PRO 140
Germantown, MD, USA (August 21, 2020) – Amarex Clinical Research, LLC, an NSF International company announced the completion of a Phase 2, randomized, double-blind, placebo-controlled clinical study evaluating efficacy and safety of PRO 140 (leronlimab) in patients with documented COVID-19 symptoms.
This Amarex managed trial’s primary endpoint shows early clinical improvement in total clinical symptom score at Day 3 in patients receiving leronlimab compared to placebo. Additionally, the secondary efficacy endpoint shows statistically significant improvement in National Early Warning Score 2 (NEWS2), an objective scale based on clinical parameters including respiratory rate, oxygen saturation, supplemental oxygen, temperature, systolic blood pressure, heart rate, and level of consciousness to identify patients at risk for rapid clinical deterioration requiring critical care intervention at End of Treatment (Day 14) when treated with leronlimab compared to placebo. Safety endpoints indicated lower incidence, frequency, and severity of both adverse events (AEs) and serious adverse events (SAEs) for those patients that received leronlimab.
Dr. Kazem Kazempour, Amarex President and CEO, stated, “We are excited by these study results, and we are working with regulatory agencies in Mexico, the U.K., Europe and the Philippines to help achieve additional emergency use approvals for leronlimab in the treatment of COVID-19 patients.”
Amarex provided all trial services for this study, including project management, study design, clinical monitoring, data management, statistics, pharmacovigilance, medical writing, and regulatory.
About Amarex Clinical Research, LLC, an NSF International company
Amarex Clinical Research, LLC, an NSF International company, is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost-efficient services. For more information visit www.amarexus.com.
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