Flexion Therapeutics Enrolls First Patients in Phase 2 Trial of ZILRETTA

Flexion Therapeutics Inc. has enrolled the first three patients in a clinical trial to evaluate the efficacy of ZILRETTA (triamcinolone acetonide extended-release injectable suspension) in patients with either shoulder osteoarthritis (OA) or adhesive capsulitis (AC), also known as frozen shoulder. The Phase 2 double-blind, placebo-controlled, study is expected to enroll up to 250 patients—approximately 135 with shoulder OA and 115 with shoulder AC.
 
“Shoulder OA and AC are both associated with pain and limited range of motion which can significantly compromise a person’s function and quality of life,” said Michael Clayman, M.D., president and CEO of Flexion. “ZILRETTA may offer these patients an important non-surgical alternative that could provide substantial and durable pain relief.”
 
The Phase 2 trial, known as the RANGE study, will separate cohorts of patients by their diagnosis of shoulder OA or AC into two parallel groups. Patients in each cohort will be randomized (1:1) to either a single intra-articular injection of ZILRETTA or normal saline. The primary endpoint for both cohorts of the trial is the magnitude of pain relief versus placebo as measured by the overall change in daily shoulder pain with movement score from baseline to eight weeks post injection. Patients in each cohort will be stratified by baseline pain scores. Shoulder AC patients will be further stratified by pain duration since onset and will also utilize a home exercise program during the study.
 
Each participant will be evaluated for 24 weeks following injection. The trial is expected to complete in the first half of 2021.
 
ZILRETTA is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. It is not intended for repeat administration.
 
On Oct. 6, 2017, ZILRETTA was approved by the U.S. Food and Drug Administration as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide—a commonly administered, short-acting corticosteroid—with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase 3 trial on which the approval of ZILRETTA was based showed that ZILRETTA significantly reduced knee pain for 12 weeks, with some people experiencing pain relief through Week 16.
 
Osteoarthritis, also known as degenerative joint disease, affects more than 30 million adults living in the United States and accounts for more than $185 billion in annual expenditures. It is estimated that more than 30 percent of the population over the age of 60 have symptomatic shoulder OA.¹ Adhesive capsulitis (AC) is a long lasting, painful shoulder condition commonly known as ”°frozen shoulder,”± with patients experiencing significant loss of range of motion. The average age of onset in patients is 55 years of age, with AC being more common in females and people with diabetes mellitus.²
 
Flexion Therapeutics is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of people with musculoskeletal conditions, beginning with osteoarthritis, the most common form of arthritis. Flexion is building a portfolio of non-opioid therapeutics, with the goal of making a meaningful difference in the lives of patients. The company’s core values are focus, ingenuity, tenacity, transparency and fun. 
 
References
¹ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3556427/
² https://www.ncbi.nlm.nih.gov/books/NBK532955/