There are millions of people around the globe
who live with chronic inflammatory conditions.
Osteoarthritis (OA) of the knee: This is a chronic, progressive joint disease that affects over 14 million people in the United States and remains an unmet therapeutic need. OA first begins with molecular derangement and abnormal joint tissue metabolism, followed by cartilage degradation, bone remodeling, joint inflammation, and loss of normal joint function. One of the most debilitating effects of OA is the chronic pain associated with the condition—even seemingly simple tasks often become unmanageable. This, along with a growing number of patients affected due to rising obesity rates and aging populations, magnifies the need for a new alternative solution.
Treatment options are varied but rarely address the resolution of the underlying root cause of the disease and instead mainly focus on masking the associated pain. Providers recommend physical therapy, NSAIDs, hyaluronic acid injections, steroid injections, and opioids—which can have addictive potential. At later stages, knee replacement surgery is considered, but it doesn’t always guarantee symptom resolution and comes with inherent risks and a high cost. Importantly, knee OA also significantly impacts the U.S. healthcare system, incurring approximately $40 billion in total U.S. hospital expenditures, much of which is attributed to knee replacement surgeries.
Xalud’s lead candidate, XT-150, was designed to express a proprietary version of interleukin-10 (IL-10) that would provide supplemental IL-10 to counteract pathologic dysregulation and break the pro-inflammatory cycle seen in OA. Xalud has successfully completed three Phase 1b/2a studies (NCT03282149, NCT03477487, and NCT03769662) and a multinational, double-blind, placebo-controlled Phase 2b study (NCT04124042) evaluating the safety and efficacy of XT-150 in adult participants with moderate-to-severe pain due to OA of the knee. Data presented at OARSI from the three Phase 1b/2a studies demonstrated encouraging safety and potential long duration of efficacy of a single injection of XT-150 in patients with moderate-to-severe OA of the knee. Visit our Clinical Trials page for more information on Xalud’s active studies.
For additional information on OA and its unmet need, please visit:
- Osteoarthritis Research Society International (OARSI)
Facet Joint Syndrome: This is a painful, progressive inflammatory condition affecting the vertebral joints in the back and neck. Damage to these synovial joints due to aging or trauma may result in chronic neck or back pain. The prevalence of lumbosacral facet joint syndrome is quite common—lumbar facet joints are one of the more common causes of chronic low back pain. Xalud has sponsored an ongoing clinical trial (NCT05196919) evaluating XT-150 for the treatment of facet joint syndrome.
Osteoarthritis of other joints: Xalud has plans to investigate whether to study the use of our non-viral pDNA platform in other joints besides the knee.
Amyotrophic Lateral Sclerosis (ALS): Also known as Lou Gehrig’s disease, this is a devastating, progressive neurodegenerative disorder that inflicts severe disability and leads to rapid paralysis and ultimately, death. It is characterized by degeneration of the motor neurons in the brain and spinal cord. ALS has a median survival of two to four years from symptom onset, and there are currently no cures or treatments that sufficiently improve survival. The neuroinflammation observed in ALS involves activated microglia that can release cytokines that have protective or detrimental effects on neurons. IL-10 is a microglia-related cytokine that has been observed to be associated with neuroprotection in ALS. We are currently evaluating the potential to develop a treatment for ALS using our proprietary platform.
Multiple Sclerosis (MS): 2.8 million people worldwide are estimated to have MS, with approximately 1 million in the U.S. alone. MS is characterized by a breakdown of the blood-brain barrier, demyelination, and axonal degeneration. While there are certain disease-modifying treatments for the disease, there remains a large unmet need to address the MS patient experience. We are currently evaluating the potential of our proprietary platform as a treatment for MS.
Neuropathic Pain: The estimated prevalence of neuropathic pain in the U.S. is approximately 10% of the population. This debilitating condition results from injury or damage to nerves in the body when an ensuing cycle of injury becomes established and reinforced, resulting in persistent, pathological pain. Lumbar radiculopathy, compression of a nerve root as it exits the lower part of the spinal column, affects approximately 3-5% of the population. Current treatment can include surgical management, which is often painful, costly, and only partially resolves pain symptoms.
Ophthalmic: There are millions of people diagnosed with inflammatory ophthalmic conditions such as uveitis and dry eye disease (DED). Xalud is currently evaluating strategies for the use of our platform in the treatment of various ophthalmic conditions.
Dermal: Dermal conditions such as alopecia areata and psoriasis are caused by inflammation. Xalud is currently evaluating strategies for the use of our platform in the treatment of various dermal conditions.
Next-generation development has the potential to expand tissue targeting specificity and customized delivery to broaden disease targets.