Chrysalis BioTherapeutics Announces TP508 Granted Orphan Drug Designation by FDA and EMA for Acute Radiation Syndrome

On August 27, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that Chrysalis BioTherapeutics (“Chrysalis”), a U.S. biopharmaceutical company, announced that its lead compound, TP508, had been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of acute radiation syndrome (ARS).

Acute Radiation Syndrome (ARS) is a syndrome caused by patient exposure to high doses of ionizing radiation within 24 hours, with symptoms lasting up to several months. The severity of the patient's condition and the type of symptoms largely depend on the radiation exposure. Lower doses of radiation primarily affect the human digestive system, causing symptoms such as nausea, vomiting, and decreased blood cell counts. High-dose exposure leads to neurological damage, resulting in extremely high mortality rates. Current conventional treatments for ARS include blood transfusions and antibiotic therapy.

TP508 is a natural thrombin peptide drug developed based on regenerative medicine, which can mitigate the effects of cancer radiotherapy on the body. The drug has anti-inflammatory and anti-apoptotic effects, protects tissue cells, and stimulates self-repair in various tissues. Clinical trials on human tissue repair have demonstrated the safety and efficacy of TP508.

TP508 was initially developed for the treatment of cutaneous and musculoskeletal injuries. Early-phase human clinical trials have demonstrated that the drug is particularly effective in promoting the healing of diabetic foot ulcers and is suitable for managing mass casualty incidents and severe burn patients. Currently, Chrysalis BioTherapeutics is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), to accelerate the development of TP508.

Chrysalis stated that TP508 has the potential to transform the future of regenerative medicine, save patients’ lives, and improve the quality of life for millions of people.

The Orphan Drug Act stipulates that authorized drugs for treating rare diseases shall enjoy special privileges, including tax credits for qualified clinical testing and waivers of application fees for market approval. For Chrysalis BioTherapeutics, obtaining orphan drug designation is a significant milestone that will accelerate the development and market launch of TP508.

Chrysalis BioTherapeutics, Inc., founded in 2009 and headquartered in Texas, USA, is a private biopharmaceutical company. The company primarily focuses on drug development based on regenerative medicine, creating innovative peptide therapies to save patients' lives and improve their quality of life. Chrysalis's research team leverages the body's regenerative signaling molecules to protect and activate endogenous stem cells, thereby repairing damaged tissues and organs.

“Preclinical studies have shown that TP508 can reverse the effects of radiation on blood vessels and multiple organ systems, significantly improving survival rates in patients with acute radiation syndrome (ARS),” said Dr. Laurie Sower, Executive Vice President of Chrysalis.

Dr. Darrell Carney, President and Chief Executive Officer of Chrysalis BioTherapeutics, stated, “Orphan drug designation is a critical milestone in the development and regulatory approval process for TP508. We will accelerate the development of this therapeutic agent for ARS to provide patients with innovative treatment options.”

(Compiled by Xu Xiaoxue)