Company: PCRX
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0001396814-25-000041
Chunk: 125

Company: Pacira BioSciences, Inc.
Filing Date: 2025-02-27
Form: 10-K
Item: Item 1
Chunk 125
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 chronic and acute pain applications, such as foot and ankle pain, elbow and wrist pain and pediatric care.

A pilot randomized controlled trial which compared 30 patients who underwent bilateral medial branch blocks with iovera° versus radiofrequency plus steroid injection showed a significant improvement in pain and disability index scores in patients who received an iovera° treatment versus radiofrequency. These data were presented at the 2024 North American Neuromodulation Society and the Association of Academic Physiatrists congresses.

Clinical Development Programs

PCRX-201

PCRX-201 (enekinragene inzadenovec) is our novel gene therapy vector platform in clinical development as a treatment for OA of the knee. Its innovative high-capacity adenovirus, or HCAd, design, manufacturing process, and local administration may solve many of the challenges that have made gene therapy inaccessible for common diseases like OA. Key features of the HCAd vector that support its use for treatments targeting large prevalent diseases like OA:

•Medicine where it matters. PCRX-201 is injected locally into the knee joint to boost cellular interleukin 1 receptor antagonist (IL-1Ra) production and block IL-1 pathway activation, significantly reducing chronic inflammation.

•Overcomes gene therapy pitfalls. PCRX-201’s innovative HCAd vector is more efficient at delivering genes into cells than other vectors, which means less medication needed to achieve the desired effect.

•Protein production only when needed. PCRX-201 uses an inflammation-responsive promoter to only produce IL-1Ra when needed, mimicking the body’s natural response to inflammation.

•Attractive cost of goods profile, Smaller doses, localized administration and scalable manufacturing processes translate to an attractive cost of goods profile because we could potentially make many thousands of doses in a single batch.

IL-1’s Role in Inflammation

The IL-1 pathway triggers inflammation in response to pathogens and cellular stress. IL-1Ra is a core regulator of this pathway and helps keep inflammation in balance by turning off the IL-1 pathway when it is not needed. As people age, their bodies have a more challenging time maintaining that balance. As a result, people develop chronic IL-1-driven inflammation that eventually causes joint damage and pain.

It has been well established that chronic IL-1 activation is an underlying driver of knee inflammation, joint degeneration and pain. By targeting it, we are able to target a root cause of disease rather than just alleviating only the symptoms of OA. FDA-approved drugs, such