GLASGOW, Scotland, March 19, 2026 (GLOBE NEWSWIRE) – Causeway Therapeutics, a clinical-stage biotechnology company focused on pioneering treatments for tendon diseases, has announced the presentation of data from its Phase 2 clinical trial evaluating TenoMiR® (CWT-001). This proprietary microRNA-29a (miR-29a) mimic has shown significant potential for treating lateral epicondylitis, commonly referred to as tennis elbow. The findings were presented at RNA Leaders Europe 2026, held in Vienna, Austria, from March 17 to 19, 2026.
The Phase 2 trial demonstrated that a single dose of TenoMiR, administered via ultrasound-guided injection into the affected tendon, resulted in statistically significant improvements in pain, function, and tendon structure. The treatment was well-tolerated, providing robust evidence that a correctly delivered miR-29a therapy can alleviate symptoms and enhance tendon healing.
Declan Doogan, MD, Chairman and Chief Executive Officer of Causeway, remarked, “Our Phase 2 clinical results represent the first robust evidence of disease-modifying regenerative potential in human tendon disease. We are encouraged by these positive data as we move toward the initiation of our Phase 3 study of TenoMiR for lateral epicondylitis, positioning it as one of the most advanced microRNA clinical programs in development.”
TenoMiR is a chemically synthesised mimic of miR-29a, designed to address the underlying molecular causes of tendon disease rather than merely alleviating symptoms. This innovative approach aims to stimulate natural healing processes. The Phase 2 trial, which was based on favourable Phase 1 results indicating significant improvements in tendon structure at safe and well-tolerated dose levels, was a multi-site, randomised, double-blind, placebo-controlled study involving 123 subjects with lateral epicondylitis. Two dose levels of TenoMiR were tested, and subjects were monitored over a 90-day period. Notably, 90 (73%) of the 123 subjects received the accurately administered dose across both TenoMiR and placebo groups.
The trial achieved several significant endpoints, including:
- Significant reduction in pain at 28 and 90 days, as measured by 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, evaluated through QuickDASH and patient-rated tennis elbow evaluation (PRTEE).
- Significant and sustained improvement in tendon structure over 90 days, suggesting potential disease modification as evidenced by greyscale ultrasound.
To provide a comprehensive assessment of TenoMiR relative to placebo, Causeway conducted several responder analyses that combined changes in pain, function, and structure from baseline into a composite score. Results indicated that 64% of TenoMiR patients and 12% of sham patients were considered responders, based on criteria that included improvement in NRS ≥ 60%, PRTEE ≥ 60%, and USS ≥ 20%.
TenoMiR was demonstrated to be safe and well-tolerated, both locally and systemically, with no significant changes observed in baseline laboratory values, vital signs, or electrocardiogram parameters across all treatment groups.
Neal Millar, MD, PhD, Co-founder and Chief Medical Officer of Causeway, highlighted the impact of tendinopathy, stating, “Tendinopathy imposes a massive burden on the millions of people living with the condition and the global healthcare system. This Phase 2 clinical dataset showcases the potential of TenoMiR to drive significant improvements in pain, function, and tendon structure, marking a promising step forward in the delivery of a novel treatment option to this underserved patient population.”
Following these encouraging results, Causeway is advancing towards a Phase 3 study of TenoMiR for lateral epicondylitis and a Phase 2 study of TenoMiR in patients with rotator cuff tendinopathy. The upcoming Phase 3 study will be optimised for injection accuracy based on insights gained from this trial.
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 company dedicated to developing innovative medicines for tendon diseases, which represent a significant unmet need for millions globally and pose considerable costs to healthcare systems. The company has developed a proprietary microRNA mimic, microRNA29a, that targets multiple pathways to treat chronic tendon disease, with an initial focus on upper limb tendinopathy. TenoMiR shows promise in restoring tendon structure, reducing pain, and improving function.