Sepsis is a serious condition in which overreaction in the immune system can cause life-threatening damage to organs and, if unstopped, have negative effects on the coagulation of the blood. With the combined activity profile of anticoagulant and anti-inflammatory effects, Aptahem considers Apta-1 to be highly suitable for preventing the organ damage that contributes to high mortality rates in sepsis patients.
Together with Hooke Laboratories in the US, Aptahem has performed a series of preclinical studies in which Apta-1 was assessed in a well-established preclinical model for sepsis. The results of these studies show that intravenous administration of Apta-1 correlates with improved survival of the trial animals, with higher doses producing significantly improved effects. Treatment with higher doses of Apta-1 resulted is a dose-dependent response among both pro- and anti-inflammatory cytokines in parallel with increased survival. The company’s interpretation of these results is that Apta-1 appears to have a central and significant effect that reduces mortality among the trial animals with induced sepsis.
Aptahem aims to submit its first application for the start of clinical phase-1 trials in Q4 2018 and to start a clinical study in Q1 2019.
Substance development of Apta-1 will take place in parallel with the preclinical program has been implemented, and this is expected to be completed by Q2 2018. The company will perform a toxicological evaluation program that will form the basis of the application for clinical trials to drug agency, up to Q3 2018. In parallel with the toxicological program, the company will develop further bio-analytical measurement methods. Furthermore, Apta-1 will be evaluated in two separate stability studies, in accordance with the clinical regulatory framework.