A revolutionary therapeutic
to enhance the body’s natural immune response.
A revolutionary therapeutic
to enhance the body’s natural immune response.
Pipeline: Target Indications for SP16
Inflammatory diseases are affecting close to 60 million individuals in the U.S. alone.3 SP16 is positioned as the next generation therapeutic to address this unmet need.
Unlike existing treatments, which suppress the immune response, SP16 enhances the body’s innate mechanism for resolving inflammation. Our therapeutic restores immune balance by targeting a receptor that plays a key role in mitigating inflammation. This platform technology has the potential to treat a wide range of inflammatory diseases.
Indications
Acute Kidney Injury (AKI)
Acute kidney injury (AKI) is a sudden loss of kidney function that can range from minor to complete kidney failure, often occurring as a complication of another serious illness.
The global AKI treatment market is projected to reach USD 5,289.5 million by 2035, growing at a CAGR of 7.6% from 2025 to 2035[1]. Another source estimates the market to reach USD 9,904.0 Million by 2034, with a CAGR of 5.04% from 2024 to 2034.
In preclinical models, SP16 was shown to:
- Protect kidney cells from hypoxic induced damage
- Reduce inflammatory mediated cellular responses in kidney cells
Acute Myocardial Infarction (AMI)
Acute myocardial infarction (AMI), also known as a heart attack, invokes an intense inflammatory response which increases heart damage and prolongs recovery. High levels of cardiac inflammation are associated with severe complications, including heart failure. Market potential to surpass US$ 2.49 billion by 2031, growing at a CAGR of 5.8%.
In a Phase 2a clinical trial, a single dose of SP16 was shown to:
- Reduce biomarkers of infarct size
- Reduce overall inflammation
- Improve long-term heart function (one-year post-treatment)
Chemotherapy-induced peripheral neuropathy (CIPN)
Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent complication of cancer treatment, causing sensory disturbances, balance problems, or weakness due to degeneration of peripheral nerves. CIPN affects a significant number of patients, with an estimated 68.1% prevalence in the first month after chemotherapy, 60.0% at three months, and 30% at six months. The CIPN treatment market is projected to reach $1.6 billion by 2033, growing at a CAGR of 6.1% from 2024 to 2033.
In preclinical models, SP16 was shown to:
- Alleviate neuropathic pain
- Reduce inflammation at the site of nerve injury
- Improve nerve survival, growth, and regenerative signaling
Prurigo Nodularis
Prurigo nodularis (PN) is a chronic skin condition characterized by extremely itchy nodules on the legs, arms, and trunk. PN affects approximately 72 per 100,000 people. The treatment market for this condition is expected to reach USD 1.90 Billion by 2031, growing at a CAGR of 5.30% from 2024-2031.
In preclinical models, SP16 was shown to:
- Inhibit the specific immune responses that activate the inflammatory cascade in the skin
- Reduce mediators that cause pruritis (itchy skin) (TSLP)
- Significantly reduce eosinophil infiltration in the skin
- Provide a convenient topical delivery option
- Accelerate the healing of damaged skin as shown in cutaneous wound model
References
1 Wylezinski, L. S., Gray, J. D., Polk, J. B., Harmata, A. J., & Spurlock, C. F. (2019). Illuminating an invisible epidemic: a systemic review of the clinical and economic benefits of early diagnosis and treatment in inflammatory disease and related syndromes. Journal of Clinical Medicine, 8(4), 493.
2Global data. Retrieved from https://www.globaldata.com.
1 Wylezinski, L. S., Gray, J. D., Polk, J. B., Harmata, A. J., & Spurlock, C. F. (2019). Illuminating an invisible epidemic: a systemic review of the clinical and economic benefits of early diagnosis and treatment in inflammatory disease and related syndromes. Journal of Clinical Medicine, 8(4), 493.
2Global data. Retrieved from https://www.globaldata.com.
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