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Osteoarthritis of the knee

Osteoarthritis, or degenerative joint disease, is a chronic condition in which tissue known as cartilage breaks down. When this tissue deteriorates, it leaves bones to rub against each other, causing pain and stiffness. OA usually affects the fingers and weight-bearing joints, including knees and hips. It affects both men and women and usually occurs after the age of 45, and is the most common type of arthritis, affecting the daily life of more than 21 million Americans.

Symptoms of osteoarthritis include joint aching and soreness, pain after overuse or after long periods of inactivity. Factors causing osteoarthritis and the symptoms can range from mild to severe. Factors contributing to osteoarthritis are many, including obesity, injury, heredity, joint overuse and age.

NSAIDS remain the most common pharmacological treatment option, including both over-the-counter and prescription drugs. The use of these drugs however are linked to significant health risks, including cardiovascular and gastrointestinal adverse events causing a significant number of hospitalizations and deaths every year. Hence, the medical need for safe and efficacious treatment options for patients with chronic pain related to osteoarthritis is substantial. SantoSolve believe 2PX can be such a treatment alternative to osteoarthritis patients once the product reaches the market.

Osteoarthis patients

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2PX has been documented to have significant pain relieving effect in open-label clinical trials as well as in double-blinded, placebo-controlled clinical trials The company is currently conducting its first pivotal phase III trial in osteoarthritis of the knee. This study is designed as a two arm, placebo-controlled trial over 6 months, involving 300 patients in 5 countries in Northern Europe and Russia. The recruitment into the trial was completed November 1, 2009 and we expect the trial to report sometime during 3Q 2010.

The company has started the planning activities for a confirmatory phase III trials, and believes that - conditional on positive results - it will be in a position to file for an NDA sometime during 2012.

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Osteoarthritis of the knee

In the US alone more than 20 million patients are suffering from osteoarthritis. Global sales in in the osteoarthritis market 2007 were approximately USDbn 4, around 15% oof the global pain market, and the market is expected to grow 3% annually to reach USDbn 5.5 in 2017 (Datamonitor).


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