Next stage of innovative osteoarthritis drug clinical trial begins

A trial for an innovative and ‘game-changing’ treatment for osteoarthritis taking place at the University of Liverpool has begun its second stage, bringing it one-step closer to completion.

Osteoarthritis (OA) is the most common type of arthritis in the UK, affecting more than eight million people, and is the leading cause of joint pain and stiffness in older people.

Osteoarthritis. Image credit: BruceBlaus via Wikimedia, CC-BY-SA-4.0

The University’s Clinical Trials Unit (LCTU), in partnership with AKL Research and Development Ltd (AKLRD) and the Phase I unit at the Royal Liverpool and Broadgreen University Hospitals NHS Trust, is leading a clinical trial to test a potential new drug treatment for OA, APPA*.

AKLRD identifies promising organic compounds of plant origin called secondary metabolites, with proven efficacy and safety, that are capable of being synthesized. These synthetic metabolites then undergo standard pharmaceutical clinical development. Trials have identified two molecules which act synergistically and have been brought together to create ‘APPA’, a patented drug.

In a variety of pre-clinical animal testing trials, APPA clearly demonstrated significant pain relief from OA, improved functionality and the slowing of cartilage destruction. These results led to the clinical trial being launched.

The trial, which is a partnership between the University of Liverpool, the pharmaceutical Industry and the NHS, is being led by rheumatologist Professor Robert Moots from the University’s Institute of Ageing and Chronic Disease.

Phase I of the trial comprises of two main parts:

• Single Ascending Dose (SAD) stage where a range of single doses are tested for safety in healthy volunteers
• Multiple Ascending Dose (MAD) stage where a range of doses are tested for 14 days in patients with Osteoarthritis

The SAD stage has ended and the Drug Evaluation Committee (DEC) has reviewed the SAD data and authorised the transition to the MAD phase.

Professor Moots, said: “The beginning of this stage of the trial is a significant milestone in our efforts to develop this new drug which could transform the lives of OA patients.

“Millions of osteoarthritis patients are suffering every day with severe pain because the current prescription drugs available are often not effective or cannot be used long-term.

“APPA has the potential to be an effective and ‘game-changing’ treatment for OA that could not only tackle the pain it causes but do so with excellent tolerability and also, we hope, stop the disease from causing further joint damage.”

David Miles, Chief Executive Officer of AKLRD, said: “There is a huge unmet need for an effective, well tolerated drug for OA. Although the data is at an early stage, the first part of this trial has demonstrated that APPA is living up to our expectations for a well-tolerated new medicine for OA and we are excited about seeing further results from the next phase.”

Source: University of Liverpool