COVID Interrupting Clinical Trials, Like This One

Burlington, Massachusetts-based Flexion Therapeutics, Inc. has suspended its active clinical trials in response to the 2019 novel coronavirus (COVID-19) pandemic.

The U.S. Food and Drug Administration (FDA) recently provided clinical trial guidance for the COVID-19 pandemic. Based upon this guidance, Flexion Therapeutics has temporarily suspended its phase 2 trial assessing the effectiveness of ZILRETTA^® in individuals with shoulder osteoarthritis (OA) or adhesive capsulitis (frozen shoulder).

Flexion has also temporarily postponed its phase 1 trial assessing FX201 in individuals with osteoarthritis of the knee. FX201 is its “intra-articular gene therapy product candidate.” Suspending the trials will protect both the participants and the integrity of the trials during the COVID-19 public health emergency.

Flexion President and Chief Executive Officer Mike Clayman, M.D., commented on the suspension, “The well-being of our patients, customers and employees remains our top priority, and our decision to suspend clinical trials is consistent with that goal.”

Dr. Clayman told OTW, “Stats would suggest as many as 50% or more of investigational sites are not enrolling patients anymore. ZILRETTA in shoulder OA and shoulder adhesive capsulitis has been suspended and impossible to guide with any clarity when it will be re-initiated—that depends on circumstances. But it will be re-initiated and we remain committed to exploring ZILRETTA in shoulder at the earliest feasible time point.”

He continued, “The other trial that was suspended was a single ascending dose study for our gene therapy, FX201, disappointing but the right thing to do—that patient population, frequently older, frequently with comorbidities, is not the patient population coming into a hospital-based investigational site for a clinical trial. But we are wildly enthusiastic about the potential for that product to confer long-lived pain relief for up to a year or more after a single injection and also potentially modify disease progression.”

Commenting on FX301, Dr. Clayman stated, “FX301, our peripheral nerve block for postoperative pain product, is pre-clinical development. Those pre-clinical studies are continuing. Assuming the environment is right, we hope and expect that product will be in clinic next year.”

Biopharmaceutical company Flexion Therapeutics focuses on the development and commercialization of therapies for patients with osteoarthritis. ZILRETTA is an extended-release corticosteroid approved by the FDA to manage osteoarthritis knee pain.

For OTW’s coverage of Flexion Therapeutics over the years, see “How Athletes Respond to Extended Release Corticosteroids,” “Flexion: Full Zilretta Launch,” “Flexion Submits NDA for Zilretta,” “Flexion Therapeutics OA Drug Meets Primary Endpoint,” and “Flexion Therapeutics’ Drug Trumps Saline for OA Pain Relief.”