Flexion Therapeutics Announces FDA Clearance of the Investigational New Drug Application for FX201 - Healing Genes

Flexion Therapeutics Announces FDA Clearance of the Investigational New Drug Application for FX201

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Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced clearance of the company’s Investigational New Drug (IND) application for FX201 in knee osteoarthritis (OA), a painful, chronic and progressive disease that affects more than 15 million adults living in the United States. Flexion has initiated a Phase 1 multicenter, open-label, single ascending dose study and expects to treat the first patient by the end of this year.

“Disease progression in osteoarthritis involves multiple tissues in the joint, and in preclinical models of osteoarthritis, intra-articular injection of FX201 has demonstrated improvements in bone, cartilage and synovium as well as symptomatic benefit,” said Neil Bodick, MD, PhD, Chief Scientific Officer at Flexion. “We believe a single injection of FX201 will persistently provide therapeutic concentrations of IL-1Ra, a potent anti-inflammatory protein, with the potential to both provide long-term pain relief and modify disease progression.”

FX201 is a helper-dependent non-integrating adenovirus containing the human interleukin-1 receptor antagonist (IL-1Ra) gene under the control of an inflammation sensitive promoter. Preclinical data show that gene expression persists for at least one year, and IL-1Ra expression increases in response to inflammation. Nonclinical safety and efficacy data submitted in the IND application demonstrated that a single administration of FX201 was well-tolerated, had no significant biodistribution outside the target tissues, and pharmacology studies with the rat, mouse, and horse orthologues showed symptomatic improvement and delay in disease progression. Results showing dose-dependent decreases in the severity of cartilage and bone lesions following anterior cruciate ligament transection in rats will be presented at the American College of Rheumatology (ACR) annual meeting on Tuesday, November 12th at 9:00 a.m. ET (Abstract: 1974).

The Phase 1, multicenter, open-label, dose-escalation trial will evaluate the safety and tolerability of FX201 in male and female patients, 30-80 years of age, with painful OA of the knee. The study is expected to enroll up to 24 patients across six sites in the U.S.

“We expect this study to provide data characterizing dosing, safety, and tolerability as well as initial insight into clinical activity including effects on pain, function, and structural progression in OA,” said Javad Parvizi, MS, MD, FRC, orthopedic surgeon at the Rothman Institute and principal investigator for the study. “If successful, FX201 could be transformative in the treatment of knee OA.”

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