An island biopharmaceutical company has received U.S. Food and Drug Administration clearance for its first ever human tests of a drug to treat a potentially fatal lung condition that each year affects more than 1 million people around the world.
Chrysalis BioTherapeutics announced Tuesday it had received FDA approval for clinical trials of the drug Chrysalin for treating Acute Respiratory Distress Syndrome.
“Acute lung failure or ARDS is a major unmet medical problem, globally affecting over 1 million people each year with up to 40 percent of those dying within four weeks of diagnosis,” Dr. Darrell Carney, CEO of Chrysalis, said. “Of those who survive, most experience loss of lung function or pulmonary fibrosis due to chronic inflammation or altered repair mechanisms.”
The FDA approval to enter human clinical trials is a major step for the company. The trials will be the first studies of Chrysalin, also known as TP508, for use as an injectable drug. Initially, the company will test for human safety and in 2024 test in patients with acute lung failure, Carney said.
“TP508 is a natural regenerative peptide that accelerates tissue repair and revascularization, while modulating the inflammatory response,” Carney said. “Its unique mode of action targets the root causes of ARDS and stimulates normal healing processes that could reduce fibrosis and help restore lung function. This could be a game-changer for those with lung disease.”
Studying Chrysalin as an injectable is a big step for the company because the drug only has been tested previously in humans using local delivery for treatment of bone fracture and chronic diabetic foot ulcers.
“Prior human clinical trials demonstrated that local application of TP508 could accelerate healing of bone fracture and chronic diabetic foot ulcers, but we are now showing that injecting the drug has system effects to modulate inflammation and protect organs and tissues from trauma, ischemia and radiation,” Dr. Laurie Sower, executive vice president at Chrysalis, said.
The company has received $35 million in grants and contracts to study Chrysalin for potential uses in pulmonary diseases, COVID and mitigating effects of radiation.
These contracts include funding from the National Institute of Allergy and Infectious Disease to look at potential use of Chrysalin in COVID patients. Animal studies highlighted the effect of Chrysalin in reducing lung inflammation and its potential in treating Acute Respiratory Distress Syndrome, the company said.
Chrysalin slowed the progression of the so-called cytokine storm, a condition that develops when a patient’s immune system responds too aggressively to infection, Carney said. Other animal studies show potential benefit of reducing inflammation in models of acute lung injury and chronic smoke inhalation, he said.
The National Institute of Allergy and Infectious Disease funded Chrysalis BioTherapeutics to look at Chrysalin’s effect in COVID patients.
The Biomedical Advance Research and Development Authority in its contract with the island company directed Chrysalis BioTherapeutics to study the potential efficacy of Chrysalin as a nuclear countermeasure to keep people alive after fatal doses of radiation from a nuclear attack or accident, Carney said.
In those studies involving large animals, a single injection of Chrysalin significantly increased animal survival, Carney said. Previous studies of Chrysalin and its development as an injectable drug were funded through federal grants and contracts.
BioTherapeutics is seeking investors to help fund its human clinical trials.
Chrysalis is a privately held Galveston-based biopharmaceutical company with world-wide license to the TP508 technology from the University of Texas System and the University of Texas Medical Branch.