Aptahem plans to perform a Proof-of-Concept Phase 2 study in patients with its lead candidate Apta-1
Aptahem AB (publ), a biotech company developing treatments for patients suffering from acute inflammatory diseases such as sepsis, today announces that the company has decided to revise its clinical development strategy by performing a Proof-of-Concept (PoC) study in patients as the next step in the clinical development of the drug candidate Apta-1. The aim with the planned study is to evaluate effect of Apta-1 in patients with acute and serious inflammatory diseases. The final study design is now under evaluation.
After analyzing the results from the performed Phase 1a study, including the additional studies, and having discussions with leading Key Opinion Leaders within relevant areas, the company has taken the decision to change the strategy for the clinical development program for Apta-1. The next step will be to perform a Phase 2 study in patients unlike the previously communicated plan which was to perform a study in healthy volunteers (a Phase 1b study).
CEO Mikael Lindstam comments:
”We have, after careful consideration, decided that the best and fastest way forward in the development of our lead candidate Apta-1 is to perform a Phase 2 PoC study in patients. The decision is based on all the results we have seen in the phase 1a study together with the discussions we have had with a number of experts. I am convinced that this is the best way forward considering Apta-1’s potential and to strengthen the potential to attract collaboration partners.”
For further information:
Aptahem AB
Mikael Lindstam, CEO
Tel: +46 (0)766-33 36 99
E-mail: ml@aptahem.com
This contains such information that Aptahem AB is obliged to make public according to the EU Market Abuse Regulation. The information was provided through the agency of the above contact person for publication on 18 April 2024.
About Aptahem
Aptahem AB (APTA) is a clinical stage biotechnology company that develops RNA-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.