Flexion Therapeutics Announces Treatment of First Patient in Second Cohort of FX201 Phase 1 Dose-Escalation Trial

Rhea-AI Summary

Flexion Therapeutics (Nasdaq: FLXN) announced the initiation of the second cohort in its Phase 1 clinical trial for FX201, an investigational gene therapy for osteoarthritis. The first cohort of five patients was treated, and the Drug Monitoring Committee approved advancing to the next cohort, which will include patients with Kellgren-Lawrence Grade 4 osteoarthritis. The trial aims to evaluate three dosing levels, and results are expected in 2021. FX201 is designed to provide long-term pain relief and potentially modify the progression of the disease.

Positive

• Successful treatment of first cohort of five patients in Phase 1 trial.
• DMC supported the advancement to the next dosing cohort, indicating trial progress.
• Potential for FX201 to establish a new standard in osteoarthritis treatment.

Negative

• The full results and benefits of FX201 remain uncertain until the study is completed.
• Further delays in the clinical trial could impact timelines and expectations.

• 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
  

BURLINGTON, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced the treatment of the first patient in the second cohort of the Phase 1 dose-escalation trial evaluating the safety and tolerability of FX201, an investigational, intra-articular, IL-1Ra gene therapy product candidate being developed for the treatment of osteoarthritis (OA).

"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.

About FX201
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.

About Flexion Therapeutics
Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, a type of degenerative arthritis. The Company's core values are focus, ingenuity, tenacity, transparency and fun. Visit flexiontherapeutics.com.

Forward-Looking Statements
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 Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 filed with the SEC on August 5, 2020 and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Contact:

Scott Young
Vice President, Corporate Communications & Investor Relations
T: 781-305-7194
syoung@flexiontherapeutics.com 

Julie Downs
Associate Director, Corporate Communications & Investor Relations
T: 781-305-7137
jdowns@flexiontherapeutics.com 

FAQ

What is the purpose of the Phase 1 clinical trial for FX201?

The trial aims to evaluate the safety and tolerability of FX201 for treating osteoarthritis.

When are the results from the FX201 trial expected?

Results from the trial are anticipated to be available in 2021.

What is the significance of the Drug Monitoring Committee's approval?

The DMC's approval indicates that the initial cohort results were favorable, allowing the trial to progress.

What conditions are being targeted with FX201?

FX201 is aimed at treating osteoarthritis, particularly in patients with varying levels of disease severity.

How does FX201 work as a therapy for osteoarthritis?

FX201 utilizes gene therapy to produce an anti-inflammatory protein that can help alleviate pain and potentially modify disease progression.