Clinical Pipeline

PEP for Regenerative Medicine

PEP^TM (Purified Exosome Product^TM) 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, and acute myocardial infarction, and Rion plans to submit IND applications for PEP to treat female stress urinary incontinence, a pelvic floor disorder and degenerative joint disease in the knee. 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, has also been initiated (ClinicalTrials.gov identifier: NCT04327635).

INDICATION

PRECLINICAL

PHASE 1/2

PHASE 2/3

Wound Healing

Acute Myocardial Infarction

Female Stress Urinary Incontinence

Musculoskeletal

Wound Healing

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.

Acute Myocardial Infarction

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. The ClinicalTrials.gov identifier for this study is NCT04327635.

Urinary Incontinence

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.

Additional Indications

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.

PUBLICATIONS

Rolland TJ, Peterson TE, Takhter R, et al. 2022. NPJ Regen Med. Exosome biopotentiated hydrogel restores damaged skeletal muscle in a porcine model of stress urinary incontinence.

Wellings, E., et al. 2021. Orthopaedic Journal of Sports Medicine. Intrinsic Tendon Regeneration After Application of Purified Exosome Product: An In Vivo Study.

Ren, Y., et al. 2021. Biomaterials. Effects of purified exosome product on rotator cuff tendon-bone healing in vitro and in vivo.

Ikumi, A., et al. 2021. Plastic and Reconstructive Surgery. Administration of purified exosome product in a rat sciatic nerve reverse autograft model.

Shi, A., et al. 2021. Theranostics. TGF-β loaded exosome enhances ischemic wound healing in vitro and in vivo.

Yamada, S., Behfar, A., and A. Terzic. 2021. Regen Med. (Review) Regenerative medicine clinical readiness.

Kisby, C., et al. 2021. Female Pelvic Med Reconstr Surg. (FPMRS) Exosome-induced vaginal tissue regeneration in a porcine mesh exposure model.

Kisby, C., et al. 2021. Female Pelvic Med Reconstr Surg. (FPMRS) Impact of repeat dosing and mesh exposure chronicity on exosome-induced vaginal tissue regeneration in a porcine mesh exposure model.

Shi, G., et al. 2020. Journal of Orthopaedic Research. A novel engineered purified exosome product patch for tendon healing: An explant in an ex vivo model.

Qi, J. et al. 2020. Journal of Orthopaedic Research. Characterization of a purified exosome product and its effects on canine flexor tenocyte biology.

Behfar, A. and A. Terzic. 2019. European Heart Journal. (Review) Regeneration for All: An Odyssey in Biotherapy: Authors from the Mayo Clinic discuss the evolution of the regenerative paradigm and look to the future.