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
Pre Clinical
Pre-IND
IND
Phase I
Phase II
Clinical Programs
Acute Kidney Injury following cardiac surgery
Chemotherapy-Induced Peripheral Neuropathy
Inflammatory Skin Diseases (Atopic Dermatitis, Shingles, Alopecia Areata, Pemphigus Vulgaris)
Proceeding with strategic partnership
Acute Myocardial Infarction (AMI)
Acute Lung Injury
Eosinophilic Esophagitis (EoE)
Orphan
Eosinophilic Esophagitis (EoE)
Proof of Concept
IND Enabling
Phase I
Phase II
Phase III
Chronic Inflammatory Demyelinating Neuropathy (CIDN)
Proof of Concept
IND Enabling
Phase I
Phase II
Phase III
Pemphigus Vulgaris
Proof of Concept
IND Enabling
Phase I
Phase II
Phase III
Acute
Acute Myocardial Infarction (AMI)
Proof of Concept
IND Enabling
Phase I
Phase II
Phase III
Acute Lung Injury
Proof of Concept
IND Enabling
Phase I
Phase II
Phase III
Acute Kidney Injury
Proof of Concept
IND Enabling
Phase I
Phase II
Phase III
Chronic
Atopic Dermatitis
Proof of Concept
IND Enabling
Phase I
Phase II
Phase III
Alopecia Areata
Proof of Concept
IND Enabling
Phase I
Phase II
Phase III
Chemotherapy-Induced
Neuropathic Pain (CIPN)
Proof of Concept
IND Enabling
Phase I
Phase II
Phase III
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.
Orphan indications
Eosinophilic Esophagitis (EoE)
Eosinophilic Esophagitis (EoE) results from allergen-induced inflammation of the throat. It is an orphan indication with limited treatment options. In the U.S., an estimated 150,000 patients (largely children) suffer from this disorder.
In preclinical models, SP16 was shown to:
- Control clinically significant drivers of allergic inflammation, including TSLP and TH2 associated cytokines
- Significantly reduce eosinophil infiltration at the site of injury
- Mediate clinically validated cell signaling pathways (JAK/STAT)
- Provide a convenient delivery method
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare disorder characterized by inflammation of the nerves, leading to chronic pain, weakness, numbness, and loss of function in the affected area(s). Current treatments have negative side effects and are not ideal for long-term use. The CIPD market value is anticipated to reach 3.9 billion USD by 2023.1
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
Pemphigus Vulgaris
Pemphigus vulgaris and pemphigoid skin diseases are rare, life-threatening autoimmune disorders characterized by painful blistering of the body’s mucous membranes, including those in the nose, mouth, and throat. The current standards of care often fail to control pain and cause adverse effects with long-term use. By 2026, the inflammatory skin disease treatment market is estimated at 23 billion USD.1
Well-aligned with currently understood driving forces of the disease, SP16 has the potential to:
- Reduce acute inflammation and pain
- Provide a treatment option with little to no side effects
- Prevent secondary infections of blisters (a common and serious complication)
- Accelerate healing, potentially minimizing the blister associated with tissue damage
Acute indications
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. The heart failure market is expected to grow to $22.1 billion by 2028 at a compound annual growth rate of 19.5%.1
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)
Acute Lung Injury
Acute Lung Injury (ALI) and acute respiratory distress syndrome (ARDS) are life-threatening respiratory disorders associated with an uncontrolled inflammatory response. Severe respiratory inflammation is a critical hallmark of COVID-19 infection.
In preclinical models, SP16 was shown to:
- Increase survival and reduce cytokine levels (comparable to the corticosteroid dexamethasone)
- Have bioavailability in the lung following parenteral administration
- Reduce key mediators needed for viral entry and spread
- Have broad-spectrum of anti-viral effects (including SARS-CoV-2, the virus that causes COVID-19, and other emerging infectious diseases)
Clinical trials to determine the safety and ability of SP16 to lower inflammation in hospitalized patients with COVID-19 are currently underway.
Acute Kidney Injury
Acute Kidney Injury (AKI) is defined as loss of kidney function and is a large risk factor of heart surgery. Cardiac-surgery-associated AKI is further associated with other adverse outcomes, including chronic kidney disease (CKD) and death. The AKI market is projected to reach US $31.6 billion by 2025. 1
In preclinical models, SP16 was shown to:
- Protect kidney cells from hypoxic induced damage
- Reduce inflammatory mediated cellular responses in kidney cells
Chronic Indications
Atopic Dermatitis
Atopic Dermatitis (AD), also known as eczema, is the most prevalent inflammatory skin disease in humans. Although mild cases can be managed by current treatment options, advanced AD is only treated by medications with severe side effects.
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
Alopecia Areata
Alopecia Areata (AA) is an autoimmune disease that targets the body’s hair follicles, resulting in hair loss. There are currently no FDA-approved treatments for moderate to severe disease states. The market size for AA treatment is estimated at approximately $1.7 billion USD by 2028.1
Well-aligned with currently understood driving forces of the disease, SP16 has the potential to:
- Realign TH1/TH2 immune imbalances and increase levels of crucial anti-inflammatory cytokines
- Mediate clinically significant signaling pathways in epithelial cells
- Promote pathways that play a crucial role in de novo hair follicle regeneration
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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