GLASGOW, Scotland, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Causeway Therapeutics, a clinical-stage biotechnology company developing novel medicines for tendon disease, today announced positive topline 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). Whilst the full analysis population, which included patients who did not receive the investigational therapy at the site of tendon injury, did not achieve the primary pain endpoint, results in the appropriately injected patients showed favorable results on multiple endpoints. 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, for the first time providing robust data that a correctly delivered miR29a therapy into the tendinopathic lesion relieves symptoms and improves tendon healing.

“Based on our promising Phase 2 data in lateral epicondylitis, I am confident that TenoMiR has the potential to be game-changing for patients,” said Declan Doogan, MD, Chairman and Chief Executive Officer of Causeway. “Where most therapeutic strategies for tendinopathy have been focused specifically on pain relief, TenoMiR offers a unique technology with the prospect of modifying the disease at a molecular and structural level.”

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 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 remaining patients did not receive the injection into the optimal part of the tendon. This led to the intention-to-treat analysis not meeting prespecified efficacy criteria.

Of the 90 patients who received the target dose of TenoMiR and placebo, the results achieved the following endpoints:

• Significant reduction in pain at 28 and 90 days (both on the numeric rating scale (NRS) and the ASES-E (American Shoulder and Elbow Surgeons Elbow 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)
• TenoMiR was shown to be safe and well-tolerated locally and systemically

"The results of this TenoMiR trial are highly encouraging for the treatment of tendinopathy,” said Scott Rodeo, MD, Professor, Orthopedic Surgery, Weill Medical College of Cornell University & Head Team Physician, New York Giants Football, who was an investigator in the trial. “No other currently available treatments can predictably improve the microstructure and composition of tendon. This data suggests that this treatment may have efficacy for tendinopathy in other areas, including rotator cuff, patellar tendon and Achilles tendon.” 

Based on these data, Causeway is planning a Phase 3 study of TenoMiR for lateral epicondylitis and a Phase 2 study of TenoMiR in patients with rotator cuff tendinopathy.

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/.

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