Trial to evaluate dociparstat sodium (DSTAT) as a potential treatment for hospitalized patients with severe COVID-19

INDIANAPOLIS, INDIANA, USA, June 9, 2020 /EINPresswire.com/ -- AIT Bioscience, a premier bioanalytical contract research organization (CRO), today announced the Company is providing bioanalytical analysis of clinical trial samples for Chimerix to aid in speeding patient access to a potential treatment for COVID-19. The trial will evaluate whether DSTAT can lessen inflammation and immune cell infiltration in COVID-19 patients with Acute Lung Injury (ALI).

DSTAT is a glycosaminoglycan derivative of heparin with robust anti-inflammatory properties, including the potential to address underlying causes of coagulation disorders with substantially reduced risk of bleeding complications compared to commercially available forms of heparin.

“Supporting the Chimerix initiative to treat COVID-19 complications is an embodiment of our Patients-First mindset,” said Jeff Goddard, Chief Executive Officer of AIT Bioscience. “Our unique, fully-electronic bioanalytical laboratory enables rapid deployment and the ability to scale bioassays in a safe and reliable manner even during these challenging times. The Chimerix trial offers hope to patients and families around the globe.”

“We look forward to working with AIT Bioscience in this very important evaluation of DSTAT,” said Mike Sherman, Chief Executive Officer of Chimerix.

About AIT Bioscience, LLC

AIT Bioscience, LLC, headquartered in Indianapolis, Indiana, is a premier bioanalytical contract research laboratory that provides pharmacokinetics (PK), biomarkers, and immunogenicity assessment through Ligand Binding Assay (LBA) analytics for large molecules alongside traditional and high-resolution LC-MS/MS analytics for small molecules in pre-clinical and phase I – III clinical trials. The integration of these services, supported by a state-of-the-art smart electronic laboratory environment, allows AIT Bioscience to formulate the best solution for its clients across all bioanalytical methods. AIT Bioscience delivers robust bioanalytical methods, highly knowledgeable client consultation, efficient sample logistics and rapid sample analysis from pre-IND through investigational new drug (IND) and new drug application (NDA). For more information, visit www.aitbioscience.com or email info@aitbioscience.com.

About Chimerix

Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the lives of patients living with cancer and other serious diseases. Its two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).
Dociparstat sodium is a potential first-in-class glycosaminoglycan compound derived from porcine heparin that may be dosed at much higher levels without triggering bleeding complications. In vitro and in vivo animal model data support DSTAT’s potential to reduce the inflammation and cellular infiltration associated with acute lung injury and address coagulation disorders associated with COVID-19 pathology High Mobility Group Box 1 (HMGB1) and Platelet Factor 4(PF). Separately, DSTAT inhibits the activities of several key proteins implicated in the viability of AML blasts and leukemic stem cells in the bone marrow during chemotherapy (e.g., CXCL12, selectins, HMGB1, elastase). Randomized AML Phase 2 data suggest that DSTAT may also accelerate platelet recovery post-chemotherapy via inhibition of PF4, a negative regulator of platelet production that impairs platelet recovery following chemotherapy. Chimerix is conducting a 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. BCV is an antiviral drug candidate in development as a medical countermeasure for smallpox. For further information, please visit the Chimerix website, www.chimerix.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things, the mechanism of action of DSTAT and its potential in ALI patients with COVID-19; Chimerix’s ability to develop DSTAT, including the initiation of a Phase 2/3 clinical trial for DSTAT as a potential treatment for ALI associated with COVID-19; Chimerix’s ability to submit and/or obtain regulatory approvals for DSTAT and BCV; and the timing and receipt of a potential procurement contract for BCV in smallpox. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that DSTAT may not achieve the endpoints of the Phase 2/3 clinical trial; risks that DSTAT may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; risks that development activities related to DSTAT may not be completed on time or at all; Chimerix’s reliance on a sole source third-party manufacturer for drug supply; risks that ongoing or future trials may not be successful or replicate previous trial results, or may not be predictive of real-world results or of results in subsequent trials; risks and uncertainties relating to competitive products and technological changes that may limit demand for our drugs; risks that our drugs may be precluded from commercialization by the proprietary rights of third parties; and additional risks set forth in Chimerix's filings with the Securities and Exchange Commission. These forward-looking statements represent Chimerix’s judgment as of the date of this release. Chimerix disclaims, however, any intent or obligation to update these forward-looking statements

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Jennifer Vance, PhD
AIT Bioscience
+1 317-715-8832
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