Biotech hails step forward for 'tennis elbow' drug

A Glasgow biotech company has hailed a major step in developing its ground-breaking drug for the tendon injury commonly known as tendinopathy of the lateral elbow or tennis elbow.

Causeway Therapeutics - a spin-out from the University of Glasgow and based within GRID at the Queen Elizabeth University Hospital campus - said results from a large clinical study were promising and had encouraged the company to go into full development of its proprietary drug, TenoMiR®.

This work was borne out from investigations under Professor Iain McInnes, Causeway co-founder and Head of the College of Medical, Veterinary and Life Sciences at the University of Glasgow, along with Causeway co-founders Dr Derek Gilchrist and Professor Neal Millar who discovered that a single microRNA-miR29a plays a key role in regulating the production of collagens, the proteins that give tendons their strength.

Unique

The next stage will see the biotech expose larger numbers of patients to the drug to further validate the efficacy of the product.

The drug is unique in that it is new micro RNA technology and is given as a single injection into the tendon, reducing pain, improving function and repairing the tendon, unlike any other product on the market. Its developers believe the product has potential to improve treatment for patients globally and accelerate valuation in the Glasgow-based biotech.

• Declan Doogan, Chief Executive Officer of Causeway and Visiting Professor at Glasgow University Medical School

In the Phase 2 study, the company said 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, Chief Executive Officer of Causeway and Visiting Professor at Glasgow University Medical School.

“Where most therapeutic strategies for tendinopathy have been focused specifically on pain relief, TenoMiR offers the prospect of modifying the disease at a molecular and structural level.”

The Phase 2 trial was a multi-site (USA & UK), randomised, double-blind, placebo-controlled, parallel-group study where two dose levels of TenoMiR given as a single injection were tested, and subjects were followed for 90 days.

Of the 90 out of 123 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; significant improvement in upper limb and elbow-specific function at 14, 28 and 90 days; significant and sustained improvement in tendon structure over 90 days; and TenoMiR was shown to be safe and well-tolerated locally and systemically.

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.

Improve

"The results of this TenoMiR trial are highly encouraging for the treatment of tendinopathy,” said Scott Rodeo, MD, Professor, Orthopaedic 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.”

Professor McInnes said: “The musculoskeletal field has long sought improved medical approaches to the management of acute and chronic tendon disorders – these conditions comprise a complex intersection of structural failure and associated pain and functional loss.

“The data from this study of TenoMiR are indicative of the first intervention that can promote regeneration of human tendon tissue in the context of disease, with associated symptomatic benefits. This provides compelling proof of principle and an exciting entirely novel avenue that could transform these disorders.”

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.

In 2024, the University of Glasgow’s top six spin-outs raised investment of more than £60 million, creating 250 jobs across a range of commercial and spin-out activity, and awarded more than £600,000 to 23 projects with commercial or spin-out potential as part of major funding drives in Medtech and the Arts and Humanities. 

The University is also working with its partners Scottish Enterprise and Glasgow City Council to deliver jobs, training opportunities and economic growth through Glasgow Riverside Innovation District.