KORU MEDICAL SYSTEMS, INC. KORU Medical Systems, Inc. announced the signing of a Phase III clinical supply agreement for a novel enzyme replacement therapy to treat a rare endocrinological disease. This significant milestone marks the progression of this collaboration, previously announced in July 2023. Since then, the KORU Medical Freedom System successfully passed validation testing to meet the subcutaneous infusion administration specifications for this novel drug.
The Phase III trial will evaluate bi-weekly infusions using the Freedom System. If successful in the Phase III trial, this drug would be the first disease-modifying treatment option for the 10,000 patients worldwide afflicted by this rare genetic disease. The drug has been granted Breakthrough Therapy, Rare Pediatric Disease, and Fast Track designations by the FDA, as well as Orphan Drug designation in the US and Europe.
