Aptahem comments on interesting data after finalised phase 1 study
Aptahem AB (publ), a biotechnology company developing treatments for patients suffering from acute inflammatory diseases such as sepsis, today announced that the completed double-blind randomised placebo-controlled phase 1 study in healthy volunteers also showed indications of drug efficacy.
- Aptahem has summarised and concluded all additional analyses taking into account the recently completed phase 1 study.
- At dosing, interesting immunological marker responses were noted in the subjects, prompting further analyses and evaluation of safety and mechanism of action.
- The analyses revealed that one individual had elevated inflammatory values prior to dosing. In this case, Apta-1 dosing was associated with rapid reduction of inflammatory parameters, with the first signs of normalisation seen already within 4 hours of dosing and further reduction at 6 hours to be completely reduced at the next measurement point at 24 hours. This suggests that Apta-1 could counteract inflammatory responses in individuals with ongoing inflammation.
- The latter observations are consistent with preclinical data and the proposed mechanism of action showing that Apta-1 protects against acute inflammation. This has been replicated in several independent models and reinforces the belief that Apta-1 can be developed into an effective drug against life-threatening inflammatory disease.
- Strengthened by these findings, a confirmatory Phase 2 clinical trial in patients with acute inflammatory disease is now being planned in consultation with the company’s expert advisors.
CEO Mikael Lindstam comments
“We are pleased to note that, through several careful analyses and subsequent expert discussions, we now have an indication of Apta-1’s effect and mechanism of action. This follows the unblinding of the study where we observed interesting biological markers from a healthy volunteer study participant who turned out to have an ongoing inflammation. Strengthened by these data, we now look forward to further concretising a Phase 2 study package for patients and obtaining a detailed proof-of-concept.”
For further information:
Aptahem AB
Mikael Lindstam, CEO
Tel: 0766-33 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 2 September 2024.
About Aptahem in brief
Aptahem AB (APTA) is a clinical-stage biotechnology company developing RNA-based treatments for life-threatening, acute conditions where coagulation, inflammation and tissue damage interact in the disease process. The company’s lead candidate, Apta-1, is in early clinical phase. In preclinical studies, Apta-1 has shown very good and promising results for the treatment of sepsis and critical conditions associated with sepsis through its antithrombotic, immunomodulatory and tissue repair properties. For more information, please visit www.aptahem.com.