Efficacy and Safety of TenoMiR in Lateral Epicondylitis

Last updated: March 6, 2025
Sponsor: Causeway Therapeutics
Overall Status: Active - Not Recruiting

Phase

2

Condition

Tennis Elbow

Treatment

TenoMiR

0.9% Sodium Chloride Injection

Clinical Study ID

NCT06192927
CWT-TE2
  • Ages 18-65
  • All Genders

Study Summary

This study is testing a drug called TenoMiR that is being developed for the treatment of tennis elbow (lateral epicondylitis). The study drug is a new compound that works by improving the quality of the collagen which helps repair damage to the elbow. The study drug is being developed in the hope of providing a more reliable treatment than those currently available and can be given at the time of first diagnosis, so that recovery can begin as soon as possible. The study drug has been tested in humans in an earlier study, and appeared to be safe and well-tolerated. This study aims to test the study drug in a larger number of participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria.

  1. Subject has a clinical diagnosis of lateral epicondylitis.

  2. Aside from lateral epicondylitis, the subject is otherwise healthy as determined bya responsible physician, based on medical history, physical examinations,concomitant medication, vital signs, 12-lead ECGs and clinical laboratoryevaluations. Laboratory values may be retested once at the discretion of theInvestigator.

  3. Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion (as confirmed by tenderness at lateral epicondyle and positive pick up back of chairsign).

  4. Subject's symptoms have persisted for at least 6 weeks to 9 months, despiteconservative treatment that includes 1 or combinations of:

  5. Physical therapy

  6. Splinting

  7. NSAIDs

Exclusion

Exclusion Criteria:

Subjects with any of the following will be excluded from study participation:

  1. Subject has undergone previous corticosteroid injection therapy to the affectedelbow in less than 6 months prior to enrolment.

  2. Subjects unwilling or unable to discontinue use of pain medication (opiate or NSAID)from at least 1 week prior to Investigational Medicinal Product (IMP)administration.

  3. Subject has received previous Platelet-Rich Plasma (PRP) injection to the affectedelbow.

  4. Subject uses or has recent use of medications known to affect the skeleton (e.g.,glucocorticoid usage >5 mg/day, fluoroquinolone antibiotics).

  5. Subject has undergone surgical intervention to the affected elbow for the treatmentof lateral epicondylitis.

Study Design

Total Participants: 123
Treatment Group(s): 2
Primary Treatment: TenoMiR
Phase: 2
Study Start date:
April 10, 2024
Estimated Completion Date:
June 04, 2025

Study Description

TenoMiR a chemically synthesised mimic of microRNA-29a (miR29a) which has improved stability, activity and cellular uptake while being non-immunogenic, has been created to restore miR29a levels back to pre-injury levels. TenoMiR is unique in directly targeting the key changes in collagen production associated with tendinopathy. Unlike other therapies, TenoMiR has a well-defined mode-of-action that is supported by a wealth of scientific data.

Moreover, treatment with TenoMiR does not require invasive biopsies and can be delivered at the point of initial diagnosis initiating recovery at the very earliest time. This is a global multicentre study which will test TenoMiR in a larger population, to follow on from the previous Phase 1b study in which TenoMiR appeared to be both safe and well-tolerated.

Connect with a study center

  • Panthera Biopartners

    Enfield Town, EN3 4GS
    United Kingdom

    Site Not Available

  • Glasgow Clinical Research Facility

    Glasgow,
    United Kingdom

    Site Not Available

  • Panthera Biopartners

    Glasgow, G51 4TY
    United Kingdom

    Site Not Available

  • Panthera Biopartners

    Preston, PR2 9QB
    United Kingdom

    Site Not Available

  • Panthera Biopartners

    Rochdale, OL11 4AU
    United Kingdom

    Site Not Available

  • Panthera Biopartners

    Sheffield, S2 5FX
    United Kingdom

    Site Not Available

  • Stanford Medicine

    Redwood City, California 94063
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10022
    United States

    Site Not Available

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