Flexion Therapeutics to Present at the 2020 Cell & Gene Virtual Meeting on the Mesa

Rhea-AI Summary

Flexion Therapeutics (Nasdaq:FLXN) announced that Adam Muzikant, Ph.D., will present at the 2020 Cell & Gene Virtual Meeting on the Mesa, discussing FX201, a gene therapy for osteoarthritis (OA). The Phase 1 trial of FX201, which tests the safety and tolerability in knee OA patients, has progressed to the mid-dose cohort after a successful low-dose review. Data is expected in 2021. The conference will take place from October 12, featuring over 120 presentations on advancements in regenerative medicine.

BURLINGTON, Mass., Oct. 08, 2020 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced today that Adam Muzikant, Ph.D., Senior Vice President, Business Development, will present at the annual 2020 Cell & Gene Virtual Meeting on the Mesa. Dr. Muzikant will provide a review of FX201, an investigational, intra-articular, IL-1Ra gene therapy product candidate in clinical development for the treatment of osteoarthritis (OA).

The Company is conducting an open-label, Phase 1 dose-escalation trial evaluating the safety and tolerability of FX201 in patients with knee OA. The trial is intended to test low, mid and high doses of FX201 in cohorts of five to eight patients. Following the completion of the low-dose cohort and data review by an independent Drug Monitoring Committee, the trial has advanced to enrolling the mid-dose cohort. Data from the study are anticipated in 2021.

Organized by the Alliance for Regenerative Medicine, the 2020 Cell & Gene Meeting on the Mesa will be delivered in a virtual format over the course of five days beginning on October 12. The conference will feature more than 120 presentations by leading public and private companies highlighting the technical and clinical achievements in the areas of cell therapy, gene therapy, gene editing, tissue engineering and broader regenerative medicine technologies.

About FX201
FX201 (humantakinogene hadenovec) is a novel, clinical-stage, 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 disease progression.

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 OA, the most common form of 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.

Contacts:

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

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

FAQ

What is FX201 and its significance for osteoarthritis treatment?

FX201 is an investigational gene therapy developed by Flexion Therapeutics that targets osteoarthritis by delivering anti-inflammatory proteins to the joint.

What are the current stages of the FX201 clinical trial?

The FX201 trial is currently in Phase 1 and has advanced to the mid-dose cohort after completing the low-dose cohort successfully.

When will data from the FX201 trial be available?

Data from the FX201 clinical trial is anticipated to be available in 2021.

When is the 2020 Cell & Gene Meeting on the Mesa?

The 2020 Cell & Gene Meeting on the Mesa will be held virtually from October 12 over five days.

What role will Adam Muzikant play in the Cell & Gene Meeting?

Adam Muzikant, Ph.D., will present a review of FX201 at the Cell & Gene Meeting, highlighting its development and potential benefits for osteoarthritis.