Efficacy and Safety of TenoMiR in Lateral Epicondylitis

Causeway Therapeutics

Status and phase

Completed

Phase 2

Conditions

Tennis Elbow

Treatments

Drug: 0.9% Sodium Chloride Injection

Drug: TenoMiR

Study type

Interventional

Funder types

Industry

Identifiers

NCT06192927

CWT-TE2

Details and patient eligibility

About

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.

Full 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.

Enrollment

123 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must meet all of the following inclusion criteria.

Subject has a clinical diagnosis of lateral epicondylitis.
Aside from lateral epicondylitis, the subject is otherwise healthy as determined by a responsible physician, based on medical history, physical examinations, concomitant medication, vital signs, 12-lead ECGs and clinical laboratory evaluations. Laboratory values may be retested once at the discretion of the Investigator.
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 chair sign).
Subject's symptoms have persisted for at least 6 weeks to 9 months, despite conservative treatment that includes 1 or combinations of:
1. Physical therapy
2. Splinting
3. NSAIDs

Exclusion criteria

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

Subject has undergone previous corticosteroid injection therapy to the affected elbow in less than 6 months prior to enrolment.
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.
Subject has received previous Platelet-Rich Plasma (PRP) injection to the affected elbow.
Subject uses or has recent use of medications known to affect the skeleton (e.g., glucocorticoid usage >5 mg/day, fluoroquinolone antibiotics).
Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

123 participants in 2 patient groups

TenoMiR intralesional injection

Experimental group

Description:

Drug: TenoMiR (Low Dose), Single injection Mimic of miR29a Other Names: • CWT-001 Drug: TenoMiR (High Dose), Single injection Mimic of miR29a Other Names: • CWT-001

Treatment:

Drug: TenoMiR

0.9% saline subcutaneous sham injection

Sham Comparator group

Description:

Drug: 0.9% saline Subcutaneous single injection

Treatment:

Drug: 0.9% Sodium Chloride Injection