Second cohort in Aptahem’s FIH study performed and approved by the ethics committee
Aptahem AB (publ), a biotech company developing treatments for patients suffering from acute inflammatory diseases such as sepsis, announces today that the second dose cohort in the clinical First in Human (FIH) study in healthy volunteers has been performed and approved by the Dutch ethics committee.
The purpose of the study is to evaluate safety and tolerability of Apta-1 in various doses.
As previously communicated, the second dose cohort was initiated in early January 2023 and has now been finalized and approved by the authority. Apta-1 seems to continue to be safe and well tolerated also in this dose group.
The study is progressing according to plan as the Dutch ethics committee has approved to continue with the next dose cohort. According to the regulations, the ethics committee must approve each cohort before the subsequent cohort can be initiated. Of note, there is a slight difference in that after every second cohort, in addition to safety data, results from the pharmacokinetics (PK), i.e. the amount of Apta-1 at different time points, will be included and submitted for approval.
CEO Mikael Lindstam comments:
“I am pleased to receive the news that the second cohort of the dosed healthy volunteers was successful and that the ethics committee has given us the green light to continue with the next cohort. We hope to see the same promising results in this next cohort as in the previous ones.”
For further information:
Aptahem AB
Mikael Lindstam, CEO
Tel: +46 (0)766-33 36 99
E-mail: ml@aptahem.com
About Aptahem
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