PEPTM (Purified Exosome ProductTM) may provide significant improvements over the current standard of care for an array of conditions. Three Investigational New Drug (IND) applications have been cleared by the U.S. Food and Drug Administration (FDA) for PEP to treat wound healing, acute myocardial infarction, and fistulizing Crohn’s disease, and Rion plans to submit an IND application for PEP to treat female stress urinary incontinence, a pelvic floor disorder. The first clinical trial for PEP, a phase 1b/2a study in wound healing, has been initiated (ClinicalTrials.gov identifier: NCT04664738). A second clinical trial, a phase 1b/2a study for acute myocardial infarction, will initiate in the spring of 2021 (ClinicalTrials.gov identifier: NCT04327635).
PEP promotes accelerated growth of dermal progenitors and blood vessels while reducing oxidative free radicals and inflammation to drive full thickness healing of chronic ischemic wounds. Revascularization and rapid healing has been demonstrated in preclinical animal studies. The ClinicalTrials.gov identifier for this study is NCT04664738.
PEP is the first off-the-shelf regenerative exosome designed for intravascular delivery for heart attack patients. It is designed to be administered seamlessly with established stent deployment and cardiac procedures. Its long-term viability has been shown in preclinical models to promote new blood vessel growth, cell recruitment and cell survival, ultimately leading to reduced scarring and improved heart function. A phase 1b/2a study to treat heart attack patients with PEP is planned to start recruiting patients in the spring of 2021. The ClinicalTrials.gov identifier for this study is NCT04327635.
Rion is developing PEP to treat fistulas that arise as a complication of surgery and certain inflammatory diseases. This serious condition currently has limited treatment options and represents a major unmet need.
PEP has the potential to reverse stress urinary incontinence in women with pelvic floor disorder. PEP therapy has been shown in preclinical animal models to accelerate epithelialization, neovascularization, and skeletal muscle restoration.
Rion is continuing to evaluate PEP for other indications where tissue regeneration is needed and current standards of care are insufficient.
Contact us if you are interested in learning more about our pipeline or clinical trials.