Sangart, Inc., today announced positive results from its Phase IIa proof-of-concept study of MP4OX (oxygenated pegylated hemoglobin) in severely injured trauma patients with hemorrhagic shock causing lactic acidosis. The study demonstrated that MP4OX, when given in addition to standard of care, was effective at decreasing lactate levels in treated patients. During hemorrhagic shock, inadequate perfusion of critical organs can lead to insufficient oxygenation of tissues, which can be detected by an increase in lactate levels. MP4OX is a novel oxygen therapeutic agent that is designed to provide rapid oxygen delivery to ischemic tissues.
Study data show a statistically significant greater immediate and sustained decrease of lactic acid in patients treated with MP4OX compared to patients in the control group. The study also found that a greater proportion of patients treated with MP4OX were able to attain normal lactate levels as early as four hours post-treatment. Furthermore, data demonstrated a strong trend toward outcomes benefits through multiple measures, including reducing the average total number of days patients spent in hospital. In patients treated with MP4OX, the median hospital stay was half that of the control group. Serious adverse events were of equal rates and similar in nature between the MP4OX-treated and control groups.
“Trauma patients suffer organ dysfunction from shock and lack of oxygen supply to vital tissues. Prolonged lactic acidosis, a marker of shock, correlates with a worse outcome and higher mortality rate. This study suggests that MP4OX has the ability to improve oxygen delivery to the body and subsequently reduce organ failure and other complications.” said Karim Brohi, Professor of Trauma Sciences at Barts and the London School of Medicine & Dentistry and lead study investigator. “We are excited by the results from this study as they suggest that MP4OX has the potential to improve patient outcomes compared to the current standard of care in trauma.”
The clinical trial was a multi-center, randomized, double-blind, controlled study that enrolled 51 patients who suffered trauma-induced severe hemorrhagic shock across 11 clinical sites in the United Kingdom, Germany, France and South Africa. The primary objective of the study was to measure reduction in lactate levels after infusion of MP4OX.
“The positive safety and efficacy data from this trial suggest that MP4OX could be a promising new treatment option for patients suffering an acute traumatic injury,” said Brian O’Callaghan, President and Chief Executive Officer of Sangart. “Based on these results, we plan to further development and clinical evaluation of MP4OX and initiate Phase IIb clinical studies in trauma patients. This study further reinforces the promise of our MP4 platform in the development of medicines designed to enhance the delivery of oxygen to tissues and organs that are oxygen deprived.”
Traumatic injuries, including both penetrating trauma injuries such as bullet and knife wounds and blunt trauma from car accidents and falls, cause the death of over 5 million people each year world-wide. Trauma is the leading cause of death in people under the age of 44. Despite optimal care, many patients treated for traumatic injuries suffer organ dysfunction and failure. Elevated lactate levels (lactic acidosis), which indicate hypoperfusion and anaerobic metabolism (oxygen deprivation) in tissues and organs in the body, represent metabolic failure and also cardiovascular, renal and hepatic dysfunction. Prolonged lactic acidosis correlates with worse outcomes and higher mortality.
Sangart’s product platform is based on the MP4 molecule, an investigational biopharmaceutical product designed to enhance the perfusion of oxygen-deprived (ischemic) tissues and provide targeted oxygen delivery in the capillaries. Using a novel pegylation approach, Sangart produces the MP4 molecule designed at the optimal oxygen affinity, diffusion potential and molecular size to perfuse capillaries and target oxygen delivery to tissues specifically at risk of ischemia.
Sangart is a global biopharmaceutical company dedicated to developing life-saving medicines specifically designed to enhance the perfusion and oxygenation of ischemic (oxygen deprived) tissues through targeted oxygen delivery. Based on more than a decade of research, Sangart has refined the pegylation of human hemoglobin to create a molecule, MP4, with the ability to carry oxygen through the circulatory system to prevent and treat ischemia.
To learn more about Sangart, please visit the company’s website at www.sangart.com.