1 December 2020 - - The Biomedical Advanced Research and Development Authority (BARDA) part of the Office of the Assistant secretary for Preparedness and Response within the US Department of Health and Human Services executed options to add USD 10.4m under contract # HHSO100201900016C with US-based biotechnology company Chrysalis BioTherapeutics, Inc to develop TP508 (Chrysalin) as a nuclear medical countermeasure, the company said.

Chrysalis will conduct safety studies and additional options required to achieve Emergency Use Authorization and Animal Rule approval for TP508 as a medicinal treatment for acute and delayed effects of ionizing radiation exposure.

TP508 mechanism of action represents a potential first in class countermeasure to mitigate radiation-induced vascular damage, reduce inflammation, prevent hemorrhage, and restore tissue function.

This contract modification includes options to initiate nonclinical and human clinical safety/PK studies, assay development, large scale manufacturing, and clinical formulation development.

This increases the total BARDA funding for this contract to over USD 21m.

TP508 is a regenerative peptide drug representing a natural part of human thrombin that is released upon tissue injury to stimulate vascular and stem cell repair and to regenerate damaged tissue.

TP508 has demonstrated safety and potential efficacy in non-clinical and in human clinical tissue repair trials, but it is not yet FDA-approved and only available for investigational use.

TP508 is also in development as a potential solution to prevent thrombosis and systemic vascular damage caused by SARS-CoV-2 infection.

Chrysalis BioTherapeutics is a biopharmaceutical company located in Galveston, TX. TP508 (rusalatide acetate) is licensed from The University of Texas Medical Branch Galveston, TX.