Michael D. Clayman, MD, is chief executive officer and co-founder, Flexion Therapeutics. 

Michael D. Clayman, MD

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.

 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.

Videos

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. 

Exploring Advanced Approaches for Pain Relief

Despite the more than 15 million Americans with osteoarthritis, treatment of the degenerative musculoskeletal disorder had been at a standstill, with short-term pain management with steroid injections considered standard care. However, in 2017, a new therapeutic approach was approved by the FDA that promised more sustained pain relief over time.

That therapy, triamcinolone acetonide extended-release injectable suspension, marketed as Zilretta by Flexion Therapeutics, resulted in significant reductions in knee pain for 12 weeks in patients with osteoarthritis, with some patients reporting pain relief through 16 weeks.

Although Zilretta represents an improvement over current standards of care for OA, Flexion has continued to push to address the burgeoning unmet need in this population, now with a 

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.

spoke with Flexion’s chief executive officer and co-founder, Michael D. Clayman, MD.

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.

Flexion Therapeutics believes that local administration of a gene therapy may not only improve pain management but potentially slow disease progression. 

Michael D. Clayman, MD

Articles

Exploring Advanced Approaches for Pain Relief

Harnessing Gene Therapy for Osteoarthritis