Pipeline

The company has two clinical stage projects:

1)      Severe community acquired pneumonia

The company is investigating the safety and efficacy of THR-B7 in critically ill patients with severe community-acquired pneumonia, which is one of the most common causes of death from infection. Recent studies evaluating factors associated with early death in patients with severe community-acquired pneumonia have reinforced the concept that dysfunctions in endothelial cells and platelets lead to increased bleeding risk, immunodeficiency and micro-thrombus formation and are well-documented predictors of multi-organ dysfunction and mortality. In order to address these problems, Thrombologic is testing THR-B7 to treat and prevent thrombocytopenia and endothelial cell activation in severe community-acquired pneumonia patients.

Severe community acquired pneumonia is a complex disease which begins as a bacterial infection. In certain severe community acquired pneumonia patients, the activation and effects of the inflammatory and coagulation cascades lead to multiple organ dysfunction and death. Most research and clinical studies have focused on the development of new antibiotics to treat the initial bacterial infection.  But it has become clear that it is not the bacteria that lead to multiple organ dysfunction and death but problems in the host immune and coagulation pathways.  A survival benefit is offered by early recognition and goal-directed treatment to correct deranged hemodynamic abnormalities and oxygen supply.

Severe community acquired pneumonia is the eighth leading cause of death in the US and is a serious problem worldwide despite advances in antimicrobial therapy and supportive care. Estimates of the incidence of CAP range from four to five million cases per year in the US, or an attack rate of 12 per 1000 adults per year, with about 25% requiring hospitalization. The number of hospitalized CAP cases in the US is expected to increase by one million by 2020 due to the growth of the elderly population. The annual healthcare costs are $12 billion in the US.  The  mortality rate ranges from 15-30% and most deaths occur during the first week of hospitalization. Of the 20-60% of patients that require hospitalization, approximately 10% are admitted to the ICU and 30-40% of these patients die. 

 
Clinical plan

This Phase IIa safety and dose ranging trial will to begin in Q4 2011.  It is a double-blind, randomized trial in patients with severe community acquired pneumonia investigating the safety and efficacy of co-administration of Iloprost and ascending doses of Eptifibatide compared to low-molecular weight heparin (standard treatment).
 
2)      Purpura fulminans

Purpura fulminans, an orphan disease is a rare but life-threatening disorder, characterized by hemorrhagic infarction of the skin caused by disseminated intravascular coagulation and dermal vascular thrombosis. Purpura fulminans is associated with high mortality rates (50%) owing to multiple organ dysfunction and is also accompanied by considerable long-term morbidity. It typically occurs following an infectious illness like chicken pox, scarlet fever, streptococcal pharyngitis, meningococcemia or rubella. The condition most often appears in children and symptoms occur approximately one to four weeks following the original illness.  In adults, meningococcal sepsis is the most common form, followed by pneumococcal sepsis. Necrotic lesions usually progress to distal ischemia, often necessitating skin graft and/or limb amputation. Early antibiotic administration and intensive care management according to the recommendations of severe sepsis and shock is crucial for patients’ survival. There are approximately 1,500 cases of Purpura fulminans in the US and Europe annually.
 
Clinical plan

The company is planning to begin this trial in mid-2012.