Flexion Therapeutics Announces Treatment of First Patient in Second Cohort of FX201 Phase 1 Dose-Escalation Trial
- Five patients treated in first cohort of Phase 1 clinical trial evaluating the safety and tolerability of FX201; Drug Monitoring Committee (DMC) supported the initiation of the next dosing cohort
"We are encouraged by the continued progress of the single ascending dose study of FX201,” said Michael Clayman, MD, President and Chief Executive Officer of Flexion Therapeutics. “OA is a painful, progressive disease which has no cure and although it remains early days, the data from the first cohort of five patients supports the advancement of this important program which we believe could establish a new standard for durability of pain relief and potentially modify disease progression."
The open-label, dose-escalation study is expected to enroll 15 to 24 patients, 30-80 years of age and test three doses (low, mid and high dose) of FX201 in cohorts of five to eight patients. Each patient will only receive one injection of FX201. Following the completion of the first cohort in which five patients (Kellgren-Lawrence Grade 2 or 3) were treated with the low dose of FX201, safety data were collected and reviewed by an independent DMC. After evaluating the first cohort safety data, the DMC supported continuing the trial and initiating treatment in the next dosing cohort which will include KL Grade 4 patients. The Company anticipates data from the study will be available in 2021.
FX201 (humantakinogene hadenovec) is a novel, intra-articular gene therapy product candidate which utilizes a helper-dependent adenovirus (HDAd) vector based on human serotype 5 (Ad5) that is designed to transfer a gene to cells in the joint to produce an anti-inflammatory protein, interleukin-1 receptor antagonist (IL-1Ra), under the control of an inflammation-sensitive promoter. Inflammation is a known cause of pain, and chronic inflammation is thought to play a major role in the progression of OA. By persistently suppressing inflammation, Flexion believes FX201 holds the potential to provide long-term pain relief and functional improvement, and to modify the disease.
This release contains forward-looking statements that are based on the current expectations and beliefs of Flexion. Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion timing and plans with respect to the Phase 1 clinical trial of FX201; and the potential therapeutic and other benefits of FX201, are forward looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the fact that the impacts and expected duration of the COVID-19 pandemic are uncertain and rapidly changing; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to FX201; risks related to clinical trials, including potential delays, safety issues or negative results; and other risks and uncertainties described in our filings with the
Source: Flexion Therapeutics, Inc.