IRVING, Texas--(BUSINESS WIRE)--Arugula Sciences, LLC. today announced that it has, in collaboration with its clinical partners, advanced its first therapeutic product, Signature Cord Prime™ (SIG001), with FDA approval for a Phase 1 clinical trial (NCT05234489) in the US.
This Phase 1 study is an open-label, dose-ranging assessment of safety, tolerability, preliminary efficacy, and dose effects in patients with symptomatic osteoarthritis of the knee. Signature Cord Prime™ is the first human umbilical cord allograft product to receive FDA approval to be studied as an intra-articular injection to treat the signs and symptoms of knee osteoarthritis.
Osteoarthritis is the most common form of arthritis, affecting 32.5 million adults in the U.S. Knee osteoarthritis is a chronic, degenerative, and progressive condition with an estimated incidence of 800,000 patients yearly. It is a growing worldwide epidemic and a leading cause of disability for those over the age of 60. Prevalent cases have more than doubled globally since 1990 and will affect at least half of all people in their lifetime. Surgical intervention presently remains the only means of preventing disease progression.
"This represents a significant advance for regenerative medicine as the first product of its kind to receive approval to be studied in osteoarthritis of the knee," said Dr. Ramon Coronado, Chief Scientific Officer for Arugula Sciences. "Based on the proposed mechanism of action, Arugula Sciences is exploring the impact Signature Cord Prime™ plays on inflammation, function, and cartilage protective effects.”
Arugula Sciences is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of advanced therapeutics that leverage the biological properties of human perinatal tissues and cells. All our efforts are made to support patients suffering from chronic and degenerative diseases.
“Arugula Sciences will expand a portfolio of tissue, cellular, and biologic innovations with immunomodulation and regeneration potential,” said Dr. Ramon Coronado. “Utilizing our manufacturing arm, Signature Biologics, our goal is to bring novel commercial products that are safe and effective at treating chronic illnesses”.
For more information, visit https://www.arugulasciences.com.
