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Flexion Announces FDA Clearance of FX201 for Knee OA

November 5, 2019
The investigational, locally administered gene therapy candidate aims to reduce joint inflammation.

A PPM Brief

Flexion Therapeutics (Burlington, MA) announced1 a successful Investigational New Drug (IND) application for FX201, a helper-dependent non-integrating adenovirus containing the human interleukin-1 receptor antagonist (IL-1Ra) gene under the control of an inflammation sensitive promoter, in knee osteoarthritis (OA). The company has announced that it is initiating a Phase 1 multicenter, open-label, single ascending dose study, expected to enroll up to 24 patients across six sites in the US. The trial will evaluate the safety and tolerability of FX201 in male and female patients (30 to 80 years of age) with painful OA of the knee.

“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 lead investigator Javad Parvizi, MS, MD, FRC, orthopedic surgeon at the Rothman Institute in Philadelphia, PA, in a company release.

FX201 is an investigational, locally administered gene therapy product candidate designed to stimulate the production of the anti-inflammatory protein IL-1Ra whenever inflammation is present within the joint. Chronic inflammation is thought to play a major role in the progression of OA, and by suppressing inflammation, the company believes FX201 may be able to both reduce pain and modify the disease.

(Image: 123RF)

Preclinical data has shown that gene expression persisted for at least one year, and IL-1Ra expression increased in response to inflammation. Nonclinical safety and efficacy data submitted in the IND demonstrated that a single administration of FX201 was well-tolerated with symptomatic improvement and delay in disease progression.

“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, in the release.

Gene-based therapies and disease-modifying drugs are on the rise in pain management research. See a recent PPM review on this topic, with a focus on osteoarthritis, by Don Goldenberg, MD.

Last updated on: December 4, 2019
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