BTI-203 ARDS CLINICAL RESEARCH STUDY
We are currently conducting a groundbreaking global Phase 2 clinical trial for patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to pneumonia or other infections. This 600-patient study is evaluating the treatment of recombinant human plasma gelsolin (rhu-pGSN) added to the standard of care for this condition.
13
COUNTRIES
75
SITES
600
PATIENTS
Pioneering Treatment: Key Insights on Our Clinical Study
BioAegis is conducting a global clinical research study for patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to pneumonia or other infections. This 600-patient study is evaluating the treatment of recombinant human plasma gelsolin (rhu-pGSN) added to the standard of care for this condition.
The randomized, double-blind, placebo-controlled proof-of-concept trial of rhu-pGSN added to standard of care will evaluate the efficacy (survival without organ failure on Day 28) of six doses of rhu-pGSN administered intravenously to hospitalized moderate-to-severe ARDS subjects (P/F ratio ≤150) caused by infection. It will also measure the safety and tolerability of treatment along with secondary outcomes.
75 sites have been selected in the US, Canada, UK and the EU, including Belgium, France, Italy, Germany, Netherlands, Spain and others to conduct the study. Enrollment is targeted for 600 subjects.
This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00067.
“This important study demonstrates BioAegis’ commitment to address the challenges of this complex disease which has a high mortality and is a significant driver of healthcare costs globally.”
Howard Levy,
M.B.B.Ch., Ph.D., M.M.M.
Chief Medical Officer
Important Information For PATIENTS About This Clinical Trial
Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs when there is severe damage to the lungs, such as from an infection. In ARDS, fluid leaks into the lungs, making it hard to get enough oxygen into the blood. This can be dangerous because oxygen is vital for the body to function.
ARDS can be classified as mild, moderate, or severe. Having a more severe type of ARDS means the patient has a higher risk of dying or experiencing complications.
The goal of this study is to assess how safe and effective gelsolin is when combined with treatments the patient is already receiving for moderate to severe ARDS. There are currently NO medicines approved specifically to treat ARDS.
Gelsolin is an experimental treatment. It is a recombinant product (rhu-pGSN), which is manufactured to be identical to the gelsolin that exists in your body naturally.