Aptahem presents plan for upcoming patient study

Aptahem AB (publ) announces today a synopsis for the upcoming clinical phase 2 study of the drug candidate Apta-1. The study will be performed as an open, single arm phase 2 study to evaluate the efficacy and safety of Apta-1, an innovative immunomodulatory and antithrombotic drug candidate, in patients with acute urogenital and renal conditions.

The study will be performed as a Proof-of-Concept study in adult patients diagnosed with various types of acute urogenital disorders including acute kidney disorders. Within these disorders, there are several indications with orphan status, an area where Aptahem sees great potential for Apta-1 based on its unique therapeutic profile.

To maximize the opportunities to create value from Apta-1's broad treatment potential, the study is planned to be conducted as a "basket trial", where several acute medical conditions within the relevant patient group are investigated in parallel. The study's primary objectives include biomarkers for hematology, organ function, inflammation, tissue degradation, and reduction of pathogens such as viruses and bacteria. The goal is to demonstrate both therapeutic efficacy and safety. More detailed information about the study will be published in the near future.

CEO Mikael Lindstam comments

“After careful analysis and market input, extensive dialogues with our internal and external experts – including leading opinion leaders and clinical contracting organizations – we now have a strong clinical synopsis. It is well-aligned with Apta-1’s unique properties and the needs of the market, creating good opportunities for potential partnerships and investments.”

For further information:

Aptahem AB
Mikael Lindstam, CEO
Tel: +46 (0)766-33 36 99
E-mail: [email protected]

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.