Chrysalis Receives FDA Approval to Initiate Clinical Trials with Chrysalin™ (TP508)

GALVESTON, Texas–()–Chrysalis BioTherapeutics, Inc. announced today that the US Food and Drug Administration (FDA) has given the company permission to initiate human clinical trials aimed at treating acute lung failure. With approval of its Investigational New Drug (IND) Application, Chrysalis plans to initiate a Phase 1, Safety and Pharmacokinetic (PK) study for use of Chrysalin™ (Rusalatide Acetate, TP508) as an injectable drug by year-end and testing of the drug in patients with Acute Respiratory Distress Syndrome (ARDS) in 2024.

“Acute lung failure or ARDS is a major unmet medical problem, globally affecting over one million people each year with up to 40% of those dying within four weeks of diagnosis,” said Dr. Darrell Carney, CEO of Chrysalis. “Of those that survive, most experience loss of lung function or pulmonary fibrosis due to chronic inflammation or altered repair mechanisms.”

Preclinical studies, funded by the National Institute of Allergy and Infectious Disease (NIAID), showed that Chrysalin™ (TP508) reduced inflammation caused by the COVID virus. Other animal studies show potential TP508 benefit in treating acute lung injury, chronic smoke inhalation, and mitigating radiation effects on brain and other tissues.

“TP508 is a natural regenerative peptide that accelerates tissue repair and revascularization while modulating the inflammatory response. 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,” said Carney, “This could be a game changer for those with lung disease.”

“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 systemic effects to modulate inflammation and protect organs and tissues from trauma, ischemia and radiation,” said Dr. Laurie Sower, Executive VP at Chrysalis.

Chrysalis BioTherapeutics, Inc. 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 (UTMB). Chrysalis is using UTMB, Houston-area, and national advisors to advance TP508 for treating pulmonary indications. Chrysalis drug development programs have been funded by NIAID and the Biomedical Advanced Research and Development Authority (BARDA) both part of the U.S. Department of Health and Human Services. For more information contact dcarney@chrysbio.com or visit www.chrysbio.com.

Source: http://www.businesswire.com/news/home/20230926039273/en/Chrysalis-Receives-FDA-Approval-to-Initiate-Clinical-Trials-with-Chrysalin%E2%84%A2-TP508/?feedref=JjAwJuNHiystnCoBq_hl-bQQCakZDujohEJegUyaJwquReQ0P23MrIoWkrUSV24ZevRMp3sIgu8q3wq1OF24lT93qbEzrwa15HGbLqMObxbNWfZlBntHS6jpH5ROLXsTFMkl05DM8ABqeyBleEmzJA==

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