Arugula Sciences announces FDA Approval to Proceed with Phase 1 Study of SIG002, a Perinatal-derived Secretome Product, for the Treatment of Big Toe Osteoarthritis (Hallux Rigidus)

IRVING, Texas--(BUSINESS WIRE)-- Arugula Sciences announced today that it has received clearance from the FDA for its investigational new drug (IND) application for a Phase 1, open-label, dose-ranging clinical trial of SIG002, a perinatal-derived secretome product. This trial will assess the safety, tolerability, preliminary efficacy, and dose effect of SIG002 in patients with symptomatic osteoarthritis of the first metatarsophalangeal joint.

“This is the second FDA approval of a Phase 1 clinical IND for the company,” says Ramon Coronado, Ph.D., Chief Scientific Officer. “It represents our company’s dedication to developing and testing potential effective therapeutics for patients suffering from unmet medical needs.”

Osteoarthritis is a painful condition characterized by swelling, aching, and restricted motion in one or more joints. Hallux Rigidus (HR) is osteoarthritis of the joint in the big toe – one of the most common disorders of this joint. While surgical intervention (cheilectomy, arthroplasty, arthrodesis) can correct this condition, there is a growing need for a treatment option for moderate-to-severe HR patients, especially considering how HR significantly impacts the quality of life and activities of daily living.

Perinatal tissues have been identified and used for many years to aid wound healing by reducing inflammation and promoting regeneration. Although perinatal tissues have been used with clinical success in resolving external chronic wound care indications, no injectable form free of native biological particulate product has been available to treat conditions inside the body.

Arugula Sciences has developed a novel patent-pending, room temperature stable, perinatal-derived product (SIG002) consisting of a purified secretome free of tissue fragments and cells. Molecular characterization of SIG002 has demonstrated immunoregulatory properties relevant to address the degenerative inflammatory processes involved in osteoarthritis disease etiology.

For this clinical trial, Arugula Sciences has partnered with Dr. Matthew Negaard at the Forte Orthopedic Research Institute, a not-for-profit organization associated with the Forte Sports Medicine and Orthopedics clinic in Carmel, IN. Enrolled participants with moderate HR will receive an ultrasound-guided intra-articular injection of SIG002 and will be monitored in subsequent months for safety and preliminary efficacy signals. The first participant is expected to be enrolled in February 2023.

Arugula Sciences is a clinical stage biotech company dedicated to the discovery, development, and commercialization of more effective, more precise and more widely applied therapeutics that realize the full potential of human cell and tissue based products to support and improve the natural healing process of the body in wound, musculoskeletal, pain management and disease applications. The company’s current leading asset, Signature Cord Prime™, is focused on the treatment of osteoarthritis of the knee. For more information, visit https://www.arugulasciences.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230131005123/en/