Chrysalis BioTherapeutics, Inc. has received permission from the U.S. Food and Drug Administration (FDA) to commence human clinical trials focused on treating acute lung failure. With the approval of its Investigational New Drug (IND) Application, Chrysalis intends to initiate a Phase 1, Safety and Pharmacokinetic (PK) study for the use of Chrysalin™ (Rusalatide Acetate, TP508) as an injectable drug by the end of the year. Subsequently, they plan to test the drug in patients with Acute Respiratory Distress Syndrome (ARDS) in 2024.

Acute lung failure or ARDS is a significant unmet medical issue, affecting over one million people globally each year, with up to 40% of those individuals succumbing within four weeks of diagnosis. Many survivors experience lung function loss or pulmonary fibrosis due to chronic inflammation or impaired repair mechanisms.

Preclinical studies, supported by the National Institute of Allergy and Infectious Disease (NIAID), have demonstrated that Chrysalin™ (TP508) can reduce inflammation triggered by the COVID virus. Additional animal studies have indicated the potential benefits of TP508 in treating acute lung injury, chronic smoke inhalation, and mitigating the effects of radiation on various tissues, including the brain.

TP508 is a natural regenerative peptide that accelerates tissue repair and revascularization while modulating the inflammatory response. Its unique mode of action targets the underlying causes of ARDS and stimulates normal healing processes, which may reduce fibrosis and aid in the restoration of lung function.

Dr. Laurie Sower, Executive VP at Chrysalis, stated, "Prior human clinical trials demonstrated that local application of TP508 could accelerate the healing of bone fractures and chronic diabetic foot ulcers. Still, we are now showing that injecting the drug has systemic effects to modulate inflammation and protect organs and tissues from trauma, ischemia, and radiation."