Evidence map›Paper›PMID 34963343›Full record

ArticleHuman gene therapy2022

Efficacy and Safety of FX201, a Novel Intra-Articular IL-1Ra Gene Therapy for Osteoarthritis Treatment, in a Rat Model.

Rebecca Senter, Rogely Boyce, Marko Repic, Emily Walsh Martin, Monika Chabicovsky, Geneviève Langevin-Carpentier, Agathe Bédard, Neil Bodick

Open access · hybridAbstract read
In one paragraph

Article in Human gene therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 19 citations in OpenAlex.

  1. Emerging therapies for knee osteoarthritis.Nature reviews. Rheumatology · 2026
    Review
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  4. Article
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  9. General Control Non-derepressible 2 Alleviates Cartilage Degeneration and Inhibits NLRP3 Inflammasome Activation in Osteoarthritis.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2024
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 3 countries.

Rebecca SenterFlexion Therapeutics, Inc.,† Burlington, Massachusetts, USA.ORCID 0000-0001-5650-1187
Rogely BoyceBeechy Ridge ToxPath, LLC, Clay, West Virginia, USA.
Marko RepicMC Toxicology Consulting, Vienna, Austria.
Emily Walsh MartinTremont Therapeutics, LLC, Charlestown, Massachusetts, USA.
Monika ChabicovskyMC Toxicology Consulting, Vienna, Austria.
Geneviève Langevin-CarpentierCharles River Laboratories, Senneville, Canada; and.
Agathe BédardCharles River Laboratories, Senneville, Canada; and.
Neil BodickGate Science, Inc., Moultonborough, New Hampshire, USA.
Canadian Nuclear Laboratories · CAFlexion Therapeutics (United States) · USMoulton College · GBRibon Therapeutics (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Osteoarthritis (OA) is a disabling, degenerative disease characterized by progressive cartilage and bone damage. There remains a need for local therapies that, following a single injection, can provide long-term pain relief and functional improvement and potentially delay disease progression. FX201 is a novel, intra-articular (IA), interleukin-1 receptor antagonist (IL-1Ra) gene therapy in development for the treatment of OA. In this study, we assessed the efficacy, biodistribution, and safety of helper-dependent adenovirus (HDAd)-ratIL-1Ra, the rat surrogate of FX201, and the biodistribution of FX201, in the anterior cruciate ligament transection (ACLT) rat OA model. A single IA injection of HDAd-ratIL-1Ra administered 7 days post-ACLT mitigated OA-related changes to cartilage, bone, and the synovial membrane at week 12 following surgery. Furthermore, FX201 and HDAd-ratIL-1Ra persisted for at least 92 days in the injected joint and proximal tissues with minimal evidence of vector spreading peripherally. Finally, HDAd-ratIL-1Ra showed a favorable safety profile without any local or systemic adverse effects. In conclusion, HDAd-ratIL-1Ra demonstrated local therapeutic and disease-modifying effects and was well tolerated, supporting further clinical development of FX201.

Indexed as

Interleukin 1 Receptor Antagonist ProteinOsteoarthritisAdenoviridaeAnimalsDisease Models, AnimalGenetic TherapyInjections, Intra-ArticularRatsSynovial MembraneTissue DistributionInterleukin 1 Receptor Antagonist Proteindisease models > muscle/connective tissue/bonedisease modificationFX201gene therapyimmunogenicityosteoarthritis

Identifiers

PMID34963343
PMCPMC9142767
OpenAlexW4200460557

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.