Investigational drug in phase 3 study has potential to be first DMARD for knee osteoarthritis

With global disability concerns rising, Voltarra Pharmaceuticals, Inc. and Menzies Research Institute at the University of Tasmania in Hobart, Australia, have initiated a phase 3, randomized multicenter clinical trial to assess the efficacy and safety of VOLT01 for controlling knee osteoarthritis (OA).
 
VOLT01 is a derivative of zoledronic acid (ZA), a drug that slows the loss of bone mass and treats the symptoms of OA, but produces post-dose syndrome side effects. Originally marketed by Novartis as Reclast, ZA is used to treat osteoporosis, Paget’s disease and bone cancers, a market that Voltarra estimates was $6.2 billion in 2011. ZA, administered intravenously, had sales in excess of $1.6 billion in 2012.

The World Health Organization estimates that osteoarthritis will be the leading cause of disability globally by 2020. The Centers for Disease Control and Prevention reports that osteoarthritis affects 26.9 million adults with total costs of $21.1 billion in the United Sates. In Australia, OA was estimated to affect more than 1.6 million people with total costs of $1.4 billon.

“As there are no disease-modifying antirheumatic drugs [DMARDs] available, VOLT01 has the potential to be the first that can slow the progression of osteoarthritis disease,” said Voltarra Chief Executive Officer Richard P. Becker, Jr.

The intent of the phase 3 study is to demonstrate VOLT01's superiority vs. Reclast in treating patients with knee osteoarthritis.

“The key study hypothesis is that VOLT01 reduces the loss of knee cartilage volume, as assessed by MRI, over a 2-year period in patients with clinical knee osteoarthritis, significant knee pain and bone marrow lesions,” according to Becker. 

“If VOLT01 can delay cartilage loss through its effect on bone marrow lesions, it may correlate to a decrease in knee replacement surgery. This suggests great potential for substantial cost savings through surgery reductions and quality-of-life improvements,” Becker said. 

The study is open to men and women who are aged 50 years and older; have significant knee pain on most days; show an abnormality present on an MRI scan; and are diagnosed with clinical knee osteoarthritis. The study is being conducted at 4 research sites. For study information please contact the following:

• The Menzies Research Institute, Hobart: Kathy Buttigieg, (03) 6226 6909 or Kathy.Buttigieg@utas.edu.au;

• Institute of Bone and Joint Research, The University of Sydney: Emma Smith, (02) 9463 1888 oremma.smith@sydney.edu.au;

• Monash University, Alfred Centre, Melbourne: Judy Hankin or Alice Noone, (03) 9903 0553 orjointstudy@monash.edu; and

• The Queen Elizabeth Hospital, Adelaide: Peter Rogers, (08) 8222 7369.