ALI

Inhalation of toxic chemicals, infectious pathogens (viruses,
bacteria, fungi), smoke, or hot gases, as well as chest and
airway trauma, can cause direct damage to the lungs, termed
acute lung injury [ALI]. Regardless of the way lungs become
injured, recovery can be difficult. Patients with ALI may
progress to ARDS. There are no approved drugs that prevent
progression of ALI to ARDS.

Our Solution

CXT-002-IN is being developed for delivery by portable inhaler directly to the lungs for administration by first responders and emergent/urgent care providers to reduce acute inflammation and prevent progression of ALI.

Acute Respiratory Failure | Acute Respiratory Distress Syndrome [ARF | ARDS]

ARDS is a severe, progressive, and life-threatening lung condition,
characterized by rapid onset and progression of widespread
inflammation in the lungs resulting in extreme difficulty breathing
and maintaining body oxygen levels. ARDS occurs as a result of an
underlying injury or illness, such as pneumonia, sepsis, trauma,
inhalation of harmful substances, or severe respiratory infections.
Even with best standard-of-care practices mortality from ARDS
remains 30%-50%. There are no approved drugs to treat ARDS.

Our Solution

CTX-002-NE is being developed for nebulizer delivery directly to the lungs of hospitalized and ICU patients with ARF/ARDS to reduce eliminate the inflammation associated with ARDS.

In multiple animal models of ALI/ARDS, CTX-002 has been shown to rapidly block pro-inflammatory cytokines, reduce acute respiratory inflammation, and treat ARDS to disease resolution including reduced mortality.

Acute Kidney Injuries [AKI]

Acute renal injury (AKI) is a life-threatening condition defined by acutely reduced blood flow to the kidneys. Pathogenic infections, pharmaceutical agents, noxious
chemicals, traumatic hemorrhage, sepsis, and ARDS can all cause AKI by inducing inflammatory cytokine expression in the kidney. Cytokines in the kidney cause the organ to shut down, which requires immediate intervention. AKI is very common in hospitalized patients (~5-7%) and >50% of ICU patients. Overall mortality from AKI in the ICU is ~23% and is ~46% in those requiring renal replacement care (ECRS). There are no approved therapeutics for AKI.

Our Solution

CTX-006 is being developed to treat AKI in critical care settings.

CTX-006 has shown efficacy in an aggressive model of AKI.

Toxemic Sepsis

Sepsis is a life-threatening overreaction of the immune system to a bacterial, viral, or fungal infection mediated by inflammatory cytokines. Each year ~50 million persons worldwide and >1.7 million in the US are diagnosed with sepsis. Global mortality from sepsis is ~25% and accounts for >50% of all hospital deaths (US >350K, ROW >11M). There are no approved treatments for sepsis.

Our Solution

CTX-007 is being developed as a treatment for patients diagnosed with toxemic sepsis.

CTX-007 has shown efficacy in an aggressive and lethal model of toxemic sepsis.

Diabetic Foot Ulcers [DFU]

DFUs are a common and often severe complication of diabetes.. In diabetics, skin wounds, especially in the lower extremities, do not heal normally due to persistent inflammation coupled with impaired blood flow and nerve function. DFUs are progressive and ultimately can result in severe tissue necrosis requiring amputation. DFUs are the most common reason for hospitalization of diabetic patients and the leading cause of non-traumatic amputation. The lifetime risk of developing a DFU is ~25% and life expectancy for a patient with a DFU is ~5.2 years.

Our Solution

CTX-001 & CTX-004 are being developed as an injectable drug [CTX-001] and a topical agent [CTX-004] to arrest inflammation associated with early and advanced-stage DFU.

Pressure Ulcers

Bedridden patients are prone to developing wounds called pressure ulcers (aka decubitus ulcers or bed sores) at points of prolonged contact between the body and bed surfaces. Despite standard of care countermeasures ~2.5M US patients are at risk for and ~25% develop a pressure ulcer and >50% these cases progress including ~10% that become septic. In the US, pressure ulcers are considered a “never event” meaning that if a hospitalized patient develops a pressure ulcer, the entire cost of care is burdened by the hospital and cannot be reimbursed.

Our Solution

CTX-005 is being developed as a medical countermeasure to prevent the development or progression of early-stage pressure ulcers. The product is a topical formulation for application to high-risk pressure points for bedridden patients.

Ulcerative Colitis

Ulcerative Colitis (UC) is a type of inflammatory bowel disease
(IBD) characterized by persistent inflammation and ulceration of
the inner lining of the large intestine (colon) and rectum.
Symptoms often include bloody diarrhea, abdominal pain, and
an urgent need for bowel movements. Long-term complications
can include an increased risk of colon cancer and severe
dehydration. Current treatments for IBD do not address the
underlying cause and have significant side effects.

Our Solution

CTX-003-UC is being developed as an oral medication for patients with IBD.

CTX-003-UC has demonstrated efficacy in three validated animal models of colitis.

Crohn’s Disease

Crohn’s Disease is a form of IBD that can affect any part of the gastrointestinal tract, from the mouth to the anus, but most commonly impacts the small intestine and the beginning of the colon. Symptoms are debilitating and include persistent diarrhea, abdominal pain, fatigue, weight loss, and malnutrition. Crohn’s can cause deep tissue inflammation and complications such as fistulas and intestinal blockages. Current therapeutic options are limited, often fail, and have significant side effects leaving surgical resection as the treatment of choice for sever disease.

Our Solution

CTX-003-CD is being developed as an oral medication for patients with IBD.

CTX-003-CD has demonstrated efficacy in a validated model of Crohn’s disease.