eClinical Technology and Industy News

Vaxart Announces Agreement with hVIVO to Develop World’s First Human Omicron Challenge Model

Model will be used in Vaxart’s Phase II Omicron Challenge Trial

Open Orphan subsidiary hVIVO to manufacture challenge virus and conduct characterization study

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., June 30, 2022 (GLOBE NEWSWIRE) — Vaxart, Inc. (Nasdaq: VXRT) today announced an agreement with hVIVO Services Limited, a subsidiary of Open Orphan plc (AIM: ORPH) under which hVIVO will conduct a characterization study and, if successful, develop a human challenge model based on the Omicron variant of SARS-CoV-2 with the intent to conduct a subsequent Phase II Human Challenge Trial (HCT) of Vaxart’s oral COVID-19 vaccine pill candidate.

Vaxart is developing an oral COVID-19 vaccine pill and is the first company to progress to a Phase II clinical trial with an oral candidate. Vaxart is now also the first company to announce the intent to test a vaccine candidate through a COVID-19 human challenge study using the now prevalent Omicron variant, rather than the original Wuhan strain.

hVIVO is a specialist contract research organization (CRO) and global leader in testing infectious and respiratory disease products using HCTs.

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