Wednesday, September 27, 2023
Chrysalis BioTherapeutics, Inc. made an announcement today regarding the approval from the US Food and Drug Administration (FDA) to commence human clinical trials aimed at treating acute lung failure. This approval follows the green light for its Investigational New Drug (IND) Application. Chrysalis is gearing up to initiate a Phase 1 study, focusing on Safety and Pharmacokinetics (PK), for their injectable drug, Chrysalin™ (Rusalatide Acetate, TP508), by the end of this year. Additionally, the company plans to commence testing of the drug in patients suffering from Acute Respiratory Distress Syndrome (ARDS) in 2024.
Dr. Darrell Carney, CEO of Chrysalis, emphasized the significance of this development, stating, "Acute lung failure, or ARDS, represents a substantial medical challenge, affecting over one million individuals globally each year, with up to 40% of them succumbing within four weeks of diagnosis. Survivors often experience lung function loss or pulmonary fibrosis due to chronic inflammation or disrupted repair mechanisms."
Previous preclinical research, funded by the National Institute of Allergy and Infectious Disease (NIAID), has indicated that Chrysalin™ (TP508) has the potential to reduce inflammation triggered by the COVID virus. Additionally, other animal studies have suggested potential benefits of TP508 in treating acute lung injury, addressing chronic smoke inhalation, and mitigating the effects of radiation on the brain and other tissues.
Dr. Carney explained further, saying, "TP508 is a naturally occurring regenerative peptide that accelerates tissue repair and revascularization while regulating the inflammatory response. Its distinctive mechanism of action targets the fundamental causes of ARDS and promotes normal healing processes that may reduce fibrosis and aid in the restoration of lung function. This has the potential to be a groundbreaking development for those affected by lung diseases."
Dr. Laurie Sower, Executive VP at Chrysalis, added, "Earlier human clinical trials demonstrated that the local application of TP508 could accelerate the healing of bone fractures and chronic diabetic foot ulcers. However, we are now showing that injecting the drug can have systemic effects, modulating inflammation and safeguarding organs and tissues from trauma, ischemia, and radiation."
