alphaSEPT – Development of a next-generation immunomodulating biopharmaceutical for the causal treatment of sepsis

Institution: TU München Department Chemie und Institute for Advanced Study
Applicant: Prof. Dr. Matthias J. Feige
Funding line:
Translational Research

Sepsis is an indication with an enormous unmet medical need. In western countries, more people die from sepsis than from the most common types of cancer combined. There is no effective and causative treatment available yet. To address this unmet medical need, we are developing alphaSEPT. alphaSEPT is a novel human immune signaling molecule developed in the laboratory of Prof. M. Feige. It has immunomodulatory properties that in the case of indications caused by an immune system out of control, are of central therapeutic importance. Sepsis is such an indication: Our immune system overreacts to an infection and then breaks down. Patients with sepsis die either from multi-organ failure or from secondary infections as the sepsis progresses.

For the first time, alphaSEPT offers an approach that is advantageous in the initial as well as advanced sepsis phase. Studies with the mouse protein in mice showed a significant reduction in mortality from sepsis. With his team, Prof. Feige is now developing alphaSEPT into a next-generation biopharmaceutical. The final preclinical studies, approval of alphaSEPT as an Investigational Medicinal Product (IMP) by EMA and the first-in-human study, STOP-SEPSIS I, are currently being prepared.

Funding by the ForTra gGmbH facilitates pivotal approval-relevant ex vivo studies with sepsis patients as well as healthy volunteers: (i) elucidation of the mode of action of alphaSEPT on the immune system of sepsis patients, (ii) characterization of the alphaSEPT responder patient groups, (iii) validation of the efficacy of alphaSEPT in the initial and advanced stage of sepsis and (iv) determination of the dose-response relationship.