In Aptahem’s FIH study further analytic studies will be performed
Aptahem AB (publ), a biotech company developing treatments for patients suffering from acute inflammatory diseases such as sepsis, announces today that in the double-blinded randomized placebo controlled first-in-human (FIH) clinical trial further analytic studies on the mechanism of Apta-1 are recommended which will result in a temporary hold of the study.
During the course of the study, additional analyses have been performed, which indicated interesting findings. After reviewing the data, the Data Review Committee concluded that further assays would be recommended. Aptahem are using this opportunity to gain more insight into as well as obtain a more robust understanding of the underlying mechanism of Apta-1.
These analyses are deemed crucial and important for the further clinical development of Apta-1.
The temporary hold will be reported to regulatory authorities in accordance with regulatory requirements.
The objectives with the phase 1a study is to evaluate the safety and tolerability of Apta-1 in multiple doses.
For further information:
Mikael Lindstam, CEO
Tel: +46 (0)766-33 36 99
Aptahem AB (APTA) is a clinical stage biotechnology company that develops aptamer-based pharmaceuticals for the treatment of acute, life-threatening conditions in which a combination of coagulation, inflammation and tissue damage are involved. The company’s lead candidate, Apta-1, is currently in early clinical phase. Apta-1 has in preclinical studies, by its anti-thrombotic, immunomodulating and tissue repairing characteristics, shown very positive and promising results as treatment for sepsis and critical conditions associated with sepsis. For more information, please visit www.aptahem.com