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Chimerix is currently enrolling a randomized, double blind, placebo-controlled Phase 2/3 study to evaluate the safety and efficacy of dociparstat sodium (DSTAT) in patients with ALI due to COVID-19. This study is designed to determine if DSTAT can accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19.

About DSTAT for COVID-19

COVID-19 is caused by a newly discovered coronavirus (SARS-CoV-2) that typically presents as a respiratory illness, similar to the flu, with symptoms such as a cough, fever, and in more severe cases, difficulty breathing. DSTAT has potential to improve outcomes in COVID-19 by dampening the excessive inflammation, aberrant immune cell responses, and coagulation disorders observed in severe disease.

Study Summary

The study is a 1:1 randomized, double-blind, placebo-controlled, Phase 2/3 trial to determine the safety and efficacy of DSTAT in adults with severe COVID-19 who are at high risk of respiratory failure. Eligible subjects will be those with confirmed COVID-19 who require hospitalization and supplemental oxygen therapy. The primary endpoint of the study is the proportion of subjects who survive and do not require mechanical ventilation through day 28. Additional endpoints include time to improvement as assessed by the National Institute of Allergy and Infectious Disease ordinal scale, time to hospital discharge, time to resolution of fever, number of ventilator-free days, all-cause mortality, and changes in key biomarkers (e.g. interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), high mobility group box 1 (HMGB1), C-reactive protein and d-dimer).

The Phase 2 portion of the study will enroll 24 subjects to confirm the maximum safe dose and will then expand by an additional 50 patients (74 total) at the selected dose. A formal analysis of all endpoints, including supportive biomarkers will be performed at the conclusion of the Phase 2 portion of the study. Contingent upon positive results, the Phase 3 portion of the study will enroll approximately 450 subjects.

For more information on our clinical trials, contact us at clinicaltrials@chimerix.com

Visit the study page on clinicaltrials.gov.

Chimerix plans to initiate a Phase 3 trial of DSTAT in combination with standard chemotherapy (cytarabine plus anthracycline, or “7+3”) in newly diagnosed AML patients. The scientific literature and recent clinical studies suggest that adding DSTAT to standard chemotherapy for AML may improve patient outcomes. DSTAT has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of AML.

About DSTAT for AML

DSTAT has the potential to increase the depth of response to standard chemotherapy, thereby reducing the potential for relapse, and improving long-term outcomes for patients with AML. DSTAT may enhance eradication of leukemic blasts and quiescent leukemic stem cells (LSCs) by making them more sensitive to chemotherapy.

Study Summary

The proposed Phase 3 trial will be a randomized, double-blind trial of approximately 570 newly diagnosed AML patients. The trial will include patients 60 years of age or older who have an intermediate or adverse genetic risk profile and patients between 18 and 60 years of age who have an adverse genetic risk profile. Patients will be randomized 1:1 to receive DSTAT in combination with standard of care cytarabine plus anthracycline (7+3) induction and cytarabine consolidation chemotherapy or to receive standard of care (7+3) induction and consolidation chemotherapy alone.  Patients with FLT-3 mutations will be allowed in the study and will be eligible to receive midostaurin.

The primary endpoint of the proposed trial will be overall survival (OS). In addition, FDA has indicated that event-free survival (EFS), using complete response with hematologic recovery to define induction success (CR), is acceptable as an endpoint for regulatory approval. Other endpoints to be evaluated in the proposed trial include minimal residual disease (MRD), relapse-free survival (RFS), time to hematologic recovery, and induction response.

In order to supplement the previously reported data from the pilot and Phase 2 trials and provide additional evidence of DSTAT’s mechanism of action, the proposed Phase 3 trial includes an early assessment of comparative CR and MRD rates among the first 80 evaluable patients.

For more information on our clinical trials, contact us at clinicaltrials@chimerix.com

Chimerix received authorization from the U.S. Food and Drug Administration (FDA) and Biomedical Advanced Research and Development Authority (BARDA) to begin submission of a rolling New Drug Application (NDA) for brincidofovir (BCV) with completion targeted for mid-2020. Chimerix is developing BCV as a potential medical countermeasure for treatment of smallpox under an ongoing collaboration with funding provided by the BARDA, part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services (HHS).

About BCV for Smallpox

BCV is designed to improve treatment of viral infections – relative to a related antiviral, cidofovir, by promoting oral bioavailability, reducing kidney toxicity, and enhancing delivery to the intracellular site of viral replication. In two lethal animal models of smallpox, BCV demonstrated a statistically significant survival advantage relative to placebo when administered at varying times post-infection.

The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), an enterprise with HHS, requires two antivirals for the treatment of smallpox with distinct mechanisms of action be included in the national stockpile. This is largely because mutations in the virus have been shown to confer resistance which may eliminate activity of a single agent. Mutations may occur naturally or through engineering of the virus in the context of a bio-terror threat. Importantly, mutations that confer resistance to BCV have been shown to weaken the virus, decreasing its ability to cause disease. BCV works well in vitro and in animal models with the existing countermeasures and would optimize overall preparedness upon inclusion in the United States Strategic National Stockpile as well as the countermeasure stockpiles of other countries globally.