Emergent BioSolutions Initiates Phase 1 Study Evaluating Potential Intranasal Treatment for Cyanide Poisoning

Rhea-AI Summary

Emergent BioSolutions (NYSE: EBS) has initiated a Phase 1 study administering stabilized isoamyl nitrite (SIAN) for acute cyanide poisoning treatment. The first participant was dosed on March 11, 2022. This study, funded by BARDA, aims to evaluate SIAN's safety, tolerability, and pharmacokinetics. Targeting 70 healthy participants aged 18-45, SIAN will be developed as an intranasal spray for first responders and civilians. The R&D aligns with Emergent's focus on critical public health threats.

Positive

• Initiated Phase 1 study for SIAN, treating acute cyanide poisoning.
• First participant dosed on March 11, 2022, indicating progress in clinical development.
• Study funded by BARDA demonstrates governmental support and trust in the product.

Negative

• None.

GAITHERSBURG, Md., March 11, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that it has dosed the first participant in its Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of stabilized isoamyl nitrite (SIAN), a treatment being developed for known or suspected acute cyanide poisoning. Under an existing multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA), and in collaboration with the Southwest Research Institute, Emergent is developing a single-use intranasal spray intended for administration by first responders and medical personnel following a cyanide incident.

“Emergent’s R&D efforts are grounded in our mission – to protect and enhance life,” said Kelly Warfield, Ph.D., senior vice president, research and development at Emergent BioSolutions. “We are committed to advancing unique programs like SIAN, which addresses the need for an easily administered first-line treatment for cyanide poisoning. Intranasal SIAN is being developed for potential use by both civilians and first responders and is part of our portfolio of medical countermeasures focused on priority public health threats identified by the U.S. government.”

This Phase 1, open label, single ascending dose clinical study plans to enroll 70 healthy males or non-pregnant females between the ages of 18 to 45. For more information on this study, visit clinicaltrials.gov.

This study is funded by BARDA, a division of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, under contract HHSO100201700001C.

About Emergent BioSolutions
At Emergent, our mission is to protect and enhance life. For over 20 years, we’ve been at work defending people from things we hope will never happen—so we are prepared, just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we plan to protect or enhance 1 billion lives by 2030, visit our website and follow us on LinkedIn, Twitter, and Instagram.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our ability to fill the need for an easily administered first-line treatment for cyanide poisoning and the safety and immunogenicity of the product candidate are forward-looking statements. The reader should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release.

There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including the success of the planned development program; the timing of and ability to obtain regulatory approvals for the product candidate; and our commercialization, marketing and manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Readers should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.

Investor Contact:
Robert G. Burrows
Vice President, Investor Relations
240-631-3280
burrowsr@ebsi.com  

Media Contact:
Matt Hartwig
Senior Director, Media Relations
mediarelations@ebsi.com

FAQ

What is the purpose of Emergent BioSolutions' Phase 1 study for EBS?

The Phase 1 study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of stabilized isoamyl nitrite (SIAN) for treating acute cyanide poisoning.

When was the first participant dosed in the EBS Phase 1 study?

The first participant in the Phase 1 study was dosed on March 11, 2022.

Who is funding the Phase 1 study for EBS?

The study is funded by the Biomedical Advanced Research and Development Authority (BARDA).

How many participants will be enrolled in the EBS Phase 1 study?

The Phase 1 study plans to enroll 70 healthy males or non-pregnant females aged 18 to 45.

What are the intended benefits of the SIAN treatment by EBS?

SIAN is being developed as an easily administered intranasal spray for first responders and civilians following a cyanide incident.