FX201 for Osteoarthritis

Recruiting at 7 trial locations

Overseen By Patricia D'Alessio

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Flexion Therapeutics, Inc.

Must not be taking: Immunosuppressants, Chemotherapy, others

Disqualifiers: Rheumatoid arthritis, Knee infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 105

72 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have used certain treatments like intra-articular (IA) drugs or biologics within 6 months before screening. It's best to discuss your specific medications with the trial team.

How is the drug FX201 different from other osteoarthritis treatments?

FX201 is unique because it targets the farnesoid X receptor (FXR) to reduce osteoclast activity in the subchondral bone, which helps prevent cartilage degradation and bone deterioration in osteoarthritis. This mechanism is different from other treatments that primarily focus on pain relief or inflammation reduction. ^{1 2 3 4 5}

What is the purpose of this trial?

This two-part study will be conducted in male and female patients, 30 - 80 years of age with painful OA of the index knee with Kellgren-Lawrence (K-L) Grade 2, 3 or 4. Part 1 - Single Ascending Dose (SAD) Phase: Up to three ascending doses of FX201 will be tested in cohorts of 5-8 patients. Each patient will only receive one injection of FX201. An independent Data Monitoring Committee (DMC) will review safety and guide the conduct of the study. Part 2 - Expansion Phase: Up to an additional 35 patients will be enrolled at each dose level reviewed by the DMC. Each patient will only receive one injection of FX201.

Research Team

Cecilia Barese, MD

Principal Investigator

Pacira Pharmaceuticals, Inc

Eligibility Criteria

This trial is for men and women aged 30-80 with painful knee osteoarthritis (K-L Grade 2, 3 or 4), a BMI ≤40 kg/m², who have tried at least two conservative therapies or one therapy plus an injection treatment without success. Participants must be willing to use effective contraception.

Inclusion Criteria

Written consent to participate in the study

I have tried at least two treatments for my knee arthritis without success.

I experience moderate pain in one of my joints.

Exclusion Criteria

I expect to have major surgery during the study.

My heart's electrical activity is unusual and considered significant by a doctor.

You have used any experimental medication, biologic, or medical device within the past 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD) Phase

Up to three ascending doses of FX201 will be tested in cohorts of 5-8 patients. Each patient will only receive one injection of FX201.

4 weeks per cohort

1 visit (in-person) per cohort

Expansion Phase

Up to an additional 35 patients will be enrolled at each dose level reviewed by the DMC. Each patient will only receive one injection of FX201.

Varies based on cohort expansion

Follow-up

Participants are monitored for safety and effectiveness after treatment

104 weeks

Multiple visits over 104 weeks

Treatment Details

Interventions

• FX201

Trial Overview The study tests FX201, a new drug given as a single injection in the knee. The first part involves escalating doses in small groups monitored for safety. The second part expands patient numbers at each dose level after safety review.

Participant Groups

Group I: Mid Dose FX201 Experimental Treatment 1 Intervention

Single mid dose FX201 injection

Group II: Low Dose FX201 Experimental Treatment 1 Intervention

Single low dose FX201 injection

Group III: High Dose FX201 Experimental Treatment 1 Intervention

Single high dose FX201 injection

Who Is Running the Clinical Trial?

Flexion Therapeutics, Inc.

Lead Sponsor

Trials

20

Recruited

2,100+

Pacira Pharmaceuticals, Inc

Lead Sponsor

Trials

142

Recruited

14,300+

Headquarters

Tampa, USA

Known For

Non-opioid Pain Management

Top Products

Exparel, Zilretta, iovera

Dr. Jonathan Slonin

Pacira Pharmaceuticals, Inc

Chief Medical Officer since 2020

BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University

Frank D. Lee

Pacira Pharmaceuticals, Inc

Chief Executive Officer since 2024

BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business

References

1. Italy pubmed.ncbi.nlm.nih.gov

FXR1 impedes the development of osteoarthritis by targeting SND1. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Farnesoid X receptor agonist attenuates subchondral bone osteoclast fusion and osteochondral pathologies of osteoarthritis via suppressing JNK1/2/NFATc1 pathway. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Targeting FoxO transcription factors with HDAC inhibitors for the treatment of osteoarthritis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Knockdown of LMX1B Suppressed Cell Apoptosis and Inflammatory Response in IL-1β-Induced Human Osteoarthritis Chondrocytes through NF-κB and NLRP3 Signal Pathway. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Knockdown of FOXM1 attenuates inflammatory response in human osteoarthritis chondrocytes. [2019]