3.19.26
Causeway Therapeutics Presents Data from Phase 2 Clinical Trial of TenoMiR® for Lateral Epicondylitis at RNA Leaders Europe 2026
Data Show Statistically Significant Improvements in Pain, Function and Tendon Structure in Appropriately Dosed Patients
TenoMiR to Progress to Phase 3 Study for Lateral Epicondylitis, Making it One of the Most Advanced microRNA Clinical Programs
GLASGOW, Scotland – March 19, 2026 – Causeway Therapeutics, a clinical-stage biotechnology company developing novel medicines for tendon disease, today announced the presentation of data from its Phase 2 clinical trial evaluating TenoMiR® (CWT-001), a proprietary microRNA-29a (miR-29a) mimic, in patients with lateral epicondylitis (commonly known as tendinopathy of the elbow or tennis elbow). The data will be presented at RNA Leaders Europe 2026 taking place in Vienna, Austria on March 17-19, 2026.
In this Phase 2 study, a single dose of TenoMiR, delivered via ultrasound-guided injection into the tendinopathic lesion, resulted in statistically significant improvements in pain, function and tendon structure and was well-tolerated – providing robust data that a miR29a therapy correctly delivered into the tendinopathic lesion relieves symptoms and improves tendon healing.
“Our Phase 2 clinical results represent the first robust evidence of disease-modifying regenerative potential in human tendon disease,” said Declan Doogan, MD, Chairman and Chief Executive Officer of Causeway. “We are encouraged by these positive data as we move toward the initiation of our Phase 3 study of TenoMiR for lateral epicondylitis – making it one of the most advanced microRNA clinical programs in development.”
TenoMiR is a chemically synthesized mimic of miR-29a, developed to target the underlying molecular cause of tendon disease, not just alleviate symptoms, by stimulating natural healing. This Phase 2 trial – based on positive Phase 1 data that showed significant improvement in tendon structure at dose levels that were safe and well-tolerated – was a multi-site (USA & UK), randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety and pharmacokinetics of TenoMiR, administered via intratendinous injection in 123 subjects with lateral epicondylitis. Two dose levels of TenoMiR given as a single injection were tested, and subjects were followed for 90 days. Of the 123 subjects enrolled in the study, 90 (73%) received the correctly delivered dose (across TenoMiR and placebo groups).
The results achieved the following endpoints:
Significant reduction in pain at 28 and 90 days (both on the numeric rating scale (NRS) and the American Shoulder and Elbow Surgeons Elbow (ASES-E) Questionnaire elbow pain subscale)
Significant improvement in upper limb and elbow-specific function at 14, 28 and 90 days (QuickDASH assessing the impact of symptoms and disability on daily living, pain and sleep in the upper limb and patient-rated tennis elbow evaluation (PRTEE) assessing the impact of elbow-specific function on daily living and pain)
Significant and sustained improvement in tendon structure over 90 days, suggesting disease modification (greyscale ultrasound)
To provide a more comprehensive evaluation of TenoMiR compared to placebo, Causeway ran several responder analyses that combined the changes in pain, function and structure from baseline into a composite score, revealing that 64% of TenoMiR patients and 12% of sham patients were considered responders (criteria for response: improvement in NRS ≥ 60%, PRTEE ≥ 60% and USS ≥ 20%).
TenoMiR was shown to be safe and well-tolerated locally and systemically, with no significant changes from baseline lab values, vital signs and electrocardiogram parameters across all three treatment groups.
“Tendinopathy imposes a massive burden on the millions of people living with the condition, and on the global healthcare system. I’m thrilled to see this Phase 2 clinical dataset showcases the potential of TenoMiR to drive significant improvements in pain, function and tendon structure, as it marks a promising step forward in the delivery of a novel treatment option to this underserved patient population,” said Neal Millar, MD, PhD, Co-founder and Chief Medical Officer of Causeway.
Based on these data, Causeway is progressing toward a Phase 3 study of TenoMiR for lateral epicondylitis and a Phase 2 study of TenoMiR in patients with rotator cuff tendinopathy. The company will optimize the Phase 3 study with regard to injection accuracy based on learnings from the previous study.
Presentation details
Title: Disease Modification in Human Tendon Disease: The Clinical Translation of TenoMiR®, a First-in-Class microRNA-29a Mimic
Presenter: Neal Millar, MD, PhD, Co-Founder & Chief Medical Officer of Causeway
Date and time: Thursday, March 19 at 12:00 - 12:30pm CET
Location: Austria Center, Vienna
About Causeway Therapeutics
Causeway is a clinical-stage biotech developing novel medicines for tendon disease. Tendinopathy represents a huge unmet need for millions of patients worldwide and is a significant cost to healthcare systems. Causeway has developed a proprietary microRNA mimic, microRNA29a, that acts through multiple pathways to treat chronic tendon disease. Causeway’s initial therapeutic focus is for treatment of upper limb tendinopathy. TenoMiR has the potential to restore tendon structure, reduce pain and improve function. It promises to transform patient outcomes and enable them to reclaim their active lives. Causeway is also exploring the potential of microRNA treatments in additional indications beyond tendinopathy, initially in dermatology and cardiovascular disease. For more information, visit https://causewaytx.com/ .
Media Contact
Michael Falcone
Pearl Street Partners
michael@pearlst.com
617-990-6712