Flexion Therapeutics, Inc. will present preliminary data from a Phase 1 single ascending dose (SAD) trial of FX201 at the 2021 American Society of Gene & Cell Therapy (ASGCT) annual meeting taking place virtually May 11-14, 2021. The clinical data will be presented in a digital presentation entitled, 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 (Abstract 594). Key findings included in the ASCGT abstract: FX201 was generally well-tolerated in the initial low-dose cohort. No evidence of systemic biodistribution of FX201 in plasma or shedding in urine or at the injection site was observed in any patient, indicating that the vector remained in the encapsulated joint space. Based on IMMPACT1 criteria, two out of the five patients (40%) demonstrated substantial improvement in knee OA pain at Weeks 8, 12, and 24 following treatment with FX201. FX201 is an investigational gene therapy which utilizes a helper-dependent adenovirus (HDAd) vector devoid of all viral genes that carries a coding sequence for an anti-inflammatory protein called interleukin-1 receptor antagonist (IL-1Ra) under the control of an inflammation-responsive promoter. FX201 is injected directly into the joint space (also termed the intra-articular space) and is intended to deliver as-needed anti-inflammatory activity to joint tissues, with the goal of providing at least 6 to 12 months of meaningful pain relief and functional improvement following a single injection with the possibility of slowing disease progression.