Exploring Advanced Approaches for Pain Relief


The chief executive officer and co-founder of Flexion Therapeutics discussed the company’s pain-focused pipeline, which includes a gene therapy that targets inflammation.

Flexion Therapeutics is committed to helping the more than 15 million Americans with osteoarthritis, despite treatment of the degenerative musculoskeletal disorder at a relative standstill, with short-term pain management with steroid injections considered standard care.

The company developed triamcinolone acetonide extended-release injectable suspension (Zilretta), which was approved by the FDA in 2017, that resulted in significant reductions in knee pain for 12 weeks in patients with osteoarthritis, with some patients reporting pain relief through 16 weeks.

Flexion now looks to approach the disorder from different angle, leveraging gene therapy. The company is currently investigating FX201, an intra-articular, helper-dependent adenoviral gene therapy that responds to inflammation by producing interleukin-1 receptor antagonist. Data from its first in-human trial presented in May 2021 at the American Society for Gene and Cell Therapy virtual annual meeting showed good safety and tolerability, with substantial improvements in WOMAC-A pain intensity observed in 3 patients at week 8 and 2 patients at weeks 12 and 24.2

GeneTherapyLive spoke with Flexion’s chief executive officer and co-founder, Michael D. Clayman, MD, to learn more about the development of gene therapy FX201, as well as other pipeline candidates, including FX301, a small molecule that targets sensory fibers.

1. Flexion Therapeutics announces FDA approval of Zilretta (triamcinolone acetonide extended-release injectable suspension) for osteoarthritis (OA) knee pain. News release. Flexion Therapeutics. October 6, 2017. https://ir.flexiontherapeutics.com/news-releases/news-release-details/flexion-therapeutics-announces-fda-approval-zilrettatm
2. Kelley S, Kivitz A, Senter B, et al. Interim data from the first-in-human phase 1 trial of FX201, an intra-articular, helper-dependent adenoviral gene therapy for osteoarthritis - safety, tolerability, biodistribution, and preliminary evaluation of clinical activity in 5 patients. Presented at: ASGCT 2021 Annual Meeting.
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