NCT06192927

Efficacy and Safety of TenoMiR in Lateral Epicondylitis

A Phase 2, Multi-Centre, Randomised, Double-Blind, Sham Controlled Proof of Concept Trial Evaluating the Efficacy and Safety of TenoMiR by Injection in Subjects With Lateral Epicondylitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Causeway Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tennis Elbow

Interventions

Type	Name	Description
DRUG	TenoMiR	Single intralesional injection
DRUG	0.9% Sodium Chloride Injection	Single subcutaneous injection

Timeline

• Start date: 2024-04-10
• Primary completion: 2025-03-03
• Completion: 2025-06-12
• First posted: 2024-01-05
• Last updated: 2025-08-01

Locations

9 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study