Flexion Therapeutics Announces Podium Presentation of FX301 Preclinical Data at Virtual ANESTHESIOLOGY 2020 Meeting

Rhea-AI Summary

Flexion Therapeutics (Nasdaq:FLXN) recently presented preclinical data for FX301, a peripheral nerve block candidate, at the virtual ANESTHESIOLOGY 2020 meeting. Findings demonstrate that FX301 delivers a significant post-operative analgesic effect without impairing motor function, outperforming liposomal bupivacaine and placebo over a duration of 72 hours. The drug showed controlled release features, maintaining local concentrations while systemic levels remained low. Flexion plans to file the IND application and initiate clinical trials in 2021, aiming to address unmet needs in post-operative pain management.

Positive

• FX301 demonstrated greater analgesic effects compared to liposomal bupivacaine and placebo.
• No significant motor function impairment in treated subjects.
• Controlled drug release profile evident in FX301's thermosensitive hydrogel formulation.
• Anticipated IND application filing and clinical trials initiation in 2021.

Negative

• None.

• Previously presented preclinical findings show FX301 provided greater sustained, post-operative analgesic effect with no significant impairment in motor function compared to liposomal bupivacaine and placebo 
  

BURLINGTON, Mass., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced the podium presentation of preclinical efficacy and pharmacokinetic (PK) data for FX301, its locally administered peripheral nerve block candidate for control of post-operative pain at the virtual ANESTHESIOLOGY 2020 meeting. This is an encore presentation of data that were previously presented at the 2020 Regional Anesthesiology and Acute Pain Medicine (ASRA) and International Anesthesia Research Society (IARS) annual meetings. The podium presentation “Selective Pharmacology of a NaV1.7 Antagonist Hydrogel in a Pig Model of Nerve Block” is scheduled for 11:00 a.m. ET on Monday, October 5, 2020.

“These preclinical data showing that FX301 provided a sustained analgesic effect without motor impairment in a surgical pain model are particularly exciting as they highlight the potential of FX301 to address a significant unmet need in post-operative pain management,” said Scott Kelley, M.D., Chief Medical Officer of Flexion. “We are thrilled to share these findings in a podium presentation at the largest annual anesthesiology educational event and look forward to discussing the data with anesthesiologists from around the world.”

Highlights from the study include:

• FX301 provided both greater analgesic effect from 12 through 72 hours and a longer duration of effect through 72 hours compared to liposomal bupivacaine or placebo;
• Treatment with FX301 did not significantly affect total walking distance in animals at 2 and 24 hours post-injection; animals treated with liposomal bupivacaine experienced a significant reduction in total walking distance compared with baseline at 2 and 24 hours post-injection; and
• Systemic plasma profile of funapide, the active ingredient in FX301, remained relatively flat throughout the study, indicative of controlled drug release from the thermosensitive gel formulation, while high local concentrations of funapide were observed at the site of administration at 72 hours.

Flexion remains on track to file the Investigational New Drug (IND) application and initiate clinical trials in 2021.

About FX301
FX301 is a locally administered NaV1.7 inhibitor product candidate, known as funapide, formulated for extended release in a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion believes FX301 has the potential to provide effective pain relief for three to seven days while preserving motor function and anticipates initiating clinical trials in 2021.

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 people with musculoskeletal conditions, beginning with osteoarthritis, 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; expected regulatory and clinical developments and timelines; and the potential therapeutic and other benefits of FX301, 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 additional preclinical and other data may not support initiation of clinical trials; the risk that we may not be able to maintain and enforce our intellectual property, risks related to clinical trials, including potential delays, safety issues or negative results; risks related to key employees, markets, economic conditions, and health care reform; 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 are the key findings from Flexion Therapeutics' FX301 presentation at ANESTHESIOLOGY 2020?

FX301 showed greater analgesic effects and no motor function impairment compared to liposomal bupivacaine and placebo.

When does Flexion Therapeutics plan to start clinical trials for FX301?

Flexion aims to initiate clinical trials for FX301 in 2021.

What is FX301 intended to treat?

FX301 is designed for control of post-operative pain as a locally administered peripheral nerve block.

What is the significance of the controlled release profile of FX301?

The controlled release profile indicates sustained drug availability at the site of administration, which could enhance pain management.

How did FX301 perform in terms of motor function in preclinical studies?

Preclinical studies indicated that FX301 did not significantly impact total walking distance in treated subjects.