Lead candidate Apta-1 in sepsis
Apta-1, an RNA therapeutic, is currently one of few pharmaceutical candidates for sepsis. In a number of preclinical studies, Apta-1 has shown unique anti-inflammatory, anti-thrombotic and immunomodulating properties, which indicates that Apta-1 could be the complete solution that today’s sepsis treatment is lacking. The candidate is currently in early clinical phase.
The company has performed the preclinical studies required by the authorities to take Apta-1 into clinical phase. These preclinical studies have shown that Apta-1 does not show any signs to cause serious side-effects and that it has a multi-functional effect on severe inflammatory conditions.
Today, there is no approved treatment for sepsis or septic shock, only the SoC (Standard of Care) with antibiotics, different anti-coagulant and anti-inflammatoric treatments including supportive treatment to maintain healthy blood pressure and improve oxygenation to prevent organ failure. The medical need to develop an effective treatment for sepsis and septic shock is thus enormous given its high death rates.
Apta-1 in clinical phase
The clinical phase 1 study, which is a First in Human (FIH), was initiated in 2022. Aptahem is working with the clinical contract research organization the Centre for Human Drug Research (CHDR) to conduct the study. CHDR has long and solid experience in early-phase clinical trials with a specific methodology for clinical research in inflammation and sepsis.
Aptahem has also had advisory meetings with the German authority Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) regarding the manufacture of Apta-1 for the clinical studies. BfArM has world-leading experts in the field of oligonucleotides, which is the type of chemical substance to which Apta-1 belongs, and they are also recognized as a leading authority in Europe with long and solid experience and competence. BfArM has confirmed their positive view of Apta-1’s development program and that Apta-1 meets the requirements for entering clinical phase.
Aptahem collaborates with academic groups around the world to understand how the company’s drug candidate Apta-1 functions in different conditions related to sepsis or other acute inflammatory conditions, as well as further explore its inherent potential.
Aptahem also builds a network of Key Opinion Leaders (KOLs) to have access to the latest finding in their respective scientific areas, and to strenghthen the company’s position in the scientific sphere.