TLC599

Treatment Options for OA Depending on Grade or Severity

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Osteoarthritis (OA) is a joint disorder involving the degeneration of the articular cartilage in knee. OA leads to inflammation of the soft tissue and bony structures of the joint. This condition grows more severe over time and leads to progressive thinning of articular cartilage. Symptoms include pain, stiffness, swelling and limitation in the function of the joint. 

A number of therapeutic options exist to treat the pain associated with OA. In the early stage, oral pain medications such as acetaminophen are often prescribed, followed by oral or topical non-steroidal anti-inflammatory drugs (NSAIDs). When these therapies fail to alleviate the pain, physicians often prescribe intraarticular, or in-joint, injections of hyaluronic acid or steroid into the affected joint. If the disease continues to progress, patients may eventually require joint replacement surgery, which is expensive and may require substantial recovery time.

Despite the use of currently available intraarticular treatments, many OA patients experience persistent and worsening pain. There exists a need for a safe alternative treatment that could provide both rapid and sustained relief from OA pain and potentially delay the need for joint replacement surgery. TLC599 aims to fulfill this need.

According to the Arthritis Foundation, there were an estimated 30.8 million OA patients in the United States in 2015, with the number of patients expected to grow as a result of aging, obesity and sports injuries. According to data published in October 2010 by the National Institutes of Health, by 2030 an estimated 20% of Americans over the age of 65 will be at risk of developing OA.

TLC599 is our proprietary BioSeizer® formulation of dexamethasone  sodium phosphate (DSP) designed to provide sustained pain management for up to 24 weeks. TLC599 has the potential to enable patients to receive both immediate and sustained benefit from the local delivery of a highly potent and clinically validated steroid that typically has a very short half-life. Our clinical data suggests that we may be able to achieve a best-in-class duration of action for an intraarticular steroid. In a Phase II trial, a single intraarticular injection of TLC599 resulted in statistically significant and clinically meaningful improvement in pain relief in both the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) scores compared to placebo from Day 3 all the way through the end of the study at 24 weeks. Over half of the patients in the TLC599 group had a durable response, maintaining at least 30% pain reduction in both WOMAC and VAS pain scores at all visits through the entire 24 weeks.

 

 

 

API

Dexamethasone sodium phosphate

DDS Platform

BioSeizer®

Indication

Osteoarthritis pain

Advantages

  • Potential to rapid pain relief and maintain up to 24 weeks
  • Minimized cartilage damage and toxicity
  • Improved drug retention in joint
  • Flexibility of needle size to allow for future expanded indications into small joints

Development Status

Phase III clinical trial ongoing