TP508 (Chrysalin) Peptide Technology
TP508
TP508 is as an injectable drug used to mitigate vascular damage, hemorrhage, and inflammation observed in ARDS induced by viral infection (COVID19) or nuclear radiation. TP508 also activates stem cells to regenerate tissues and restore function. Because TP508 can affect cellular processes involved in ARDS progression at multiple points, it has the advantage of potentially showing efficacy where previous candidate drugs have failed
Drug Status
As an investigational drug product, TP508 is ready for additional clinical trials.
- Production: synthetic peptide drug substance is cGMP manufactured by AmbioPharm, Inc.
- Formulation: lyophilized white powder contained in single-use vials to be dissolved in saline and filter sterilized prior to clinical trial injection
- Stability: Raw drug product = 6+ years at -20°C
- Non-Human Safety: GLP single and multiple IV and SC injection toxicology, repro-tox, oncogenicity and QT prolongation studies, rodent and non-rodent PK/ADME
- Human Clinical Safety: No drug related adverse effects with local administration to ~600 human subjects.
TP508 (Chrysalin®, rusalatide acetate) is a GMP manufactured 23 amino acid peptide that represents a natural region of human thrombin that is released at the site of injury to initiate tissue revascularization, regeneration and repair. TP508 has demonstrated human safety and efficacy in clinical trials for diabetic foot ulcers and fracture repair using local administration to the site of injury. Chrysalis is developing TP508 for systemic administration to treat ARDS and other diseases based on its ability to restore vascular function, mediate inflammatory responses, and stimulate tissue repair and regeneration. Preclinical data has demonstrated that TP508 injection mitigates effects of radiation and lung damage and inflammation induced by acute injury and COVID infection.
TP508 binds receptors expressed on the surface of endothelial cells, stem cells, and certain inflammatory cells. Upon binding to these receptors, TP508 activates a signaling cascade that restores vascular function in endothelial cells, stimulates proliferation and mobilization of progenitor stem cells, and reduces inflammation.
TP508 (Chrysalin®, rusalatide acetate) is a GMP manufactured 23 amino acid peptide that represents a natural region of human thrombin that is released at the site of injury to initiate tissue revascularization, regeneration and repair. TP508 has demonstrated human safety and efficacy in clinical trials for diabetic foot ulcers and fracture repair using local administration to the site of injury. Chrysalis is developing TP508 for systemic administration to treat ARDS and other diseases based on its ability to restore vascular function, mediate inflammatory responses, and stimulate tissue repair and regeneration. Preclinical data has demonstrated that TP508 injection mitigates effects of radiation and lung damage and inflammation induced by acute injury and COVID infection.
TP508 binds receptors expressed on the surface of endothelial cells, stem cells, and certain inflammatory cells. Upon binding to these receptors, TP508 activates a signaling cascade that restores vascular function in endothelial cells, stimulates proliferation and mobilization of progenitor stem cells, and reduces inflammation.
Drug Status
As an investigational drug product, TP508 is ready for additional clinical trials.
- Production: synthetic peptide drug substance is cGMP manufactured by AmbioPharm, Inc.
- Formulation: lyophilized white powder contained in single-use vials to be dissolved in saline and filter sterilized prior to clinical trial injection
- Stability: Raw drug product = 6+ years at -20°C
- Non-Human Safety: GLP single and multiple IV and SC injection toxicology, repro-tox, oncogenicity and QT prolongation studies, rodent and non-rodent PK/ADME
- Human Clinical Safety: No drug related adverse effects with local administration to ~600 human subjects.
Acute respiratory distress syndrome (ARDS) affects more than 3 million people each year globally and ~180,000 patients in the US, accounting for 10% of intensive care unit admissions, of which the mortality rate is ~30%. The Global ARDS Market in 2019 (prior to COVID) was $620 million. It is projected to be approximately $1 billion in 2027. To date, there are no effective pharmacological therapies specifically approved for ARDS. ARDS is characterized by poor oxygenation, pulmonary infiltrates, and acuity of onset. On a microscopic level, the disorder is associated with diffuse alveolar damage and capillary endothelial injury. The lungs are full of tiny sac-like structures called alveoli. It is in the alveoli where oxygen and carbon dioxide are exchanged between the air inhaled and the blood that perfuses the lungs in tiny vessels called capillaries. When the lungs are injured, for instance by an infection or traumatic event, inflammatory white blood cells are recruited to the area of injury and fluids leak from the capillaries into the alveoli restricting oxygen passage from the alveoli into blood causing hypoxia, scar tissue formation, and systemic effects that can lead to multi-organ failure and mortality.
TP508
TP508 is as an injectable drug used to mitigate vascular damage, hemorrhage, and inflammation observed in ARDS induced by viral infection (COVID19) or nuclear radiation. TP508 also activates stem cells to regenerate tissues and restore function. Because TP508 can affect cellular processes involved in ARDS progression at multiple points, it has the advantage of potentially showing efficacy where previous candidate drugs have failed
TP508
TP508 is being developed as an injectable drug used to mitigate vascular damage, hemorrhage, and inflammation observed in ARDS or nuclear radiation. TP508 also activates stem cells to regenerate tissues and restore function. Because TP508 can affect cellular processes involved in ARDS progression at multiple points, it has the advantage of potentially showing efficacy where previous candidate drugs have failed.
Drug Status
As an investigational drug product, TP508 is ready for additional clinical trials.
- Production: synthetic peptide drug substance is cGMP manufactured by AmbioPharm, Inc.
- Formulation: lyophilized white powder contained in single-use vials to be dissolved in saline and filter sterilized prior to clinical trial injection
- Being developed as a stable liquid formulation for future clinical trials.
- Stability: Raw drug product = 6+ years at -20°C
- Non-Human Safety: GLP single and multiple IV and SC injection toxicology, repro-tox, oncogenicity and QT prolongation studies, rodent and non-rodent PK/ADME
- Human Clinical Safety: No drug related adverse effects with local administration to ~600 human subjects.
TP508 (Chrysalin, rusalatide acetate) is a GMP manufactured 23 amino acid peptide that represents a natural region of human thrombin that is released at the site of injury to initiate tissue revascularization, regeneration and repair. TP508 has demonstrated human safety and efficacy in clinical trials for diabetic foot ulcers and fracture repair using local administration to the site of injury. Chrysalis is developing TP508 for systemic administration to treat ARDS and other diseases based on its ability to restore vascular function, mediate inflammatory responses, and stimulate tissue repair and regeneration. Preclinical data has demonstrated that TP508 mitigates radiation damage and pulmonary inflammation induced by viral, bacterial, and smoke injury.
TP508 binds receptors expressed on the surface of endothelial cells, stem cells, and certain inflammatory cells. Upon binding to these receptors, TP508 activates a signaling cascade that restores vascular function in endothelial cells, stimulates proliferation and mobilization of progenitor stem cells, and reduces inflammation
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