Aptahem reports good safety profile for Apta-1 after concluded toxicology- and safety program (non-GLP)
Aptahem (publ) announce today that the final reports from the non-regulated GLP (Good Laboratory Practice) toxicology- and safety studies in Apta-1’s pre-clinical program show positive results. The results indicate that higher dosages of Apta-1, than previously estimated, shows a very good safety profile. The company is now preparing the next step in Apta-1's pre-clinical program, which includes regulatory GLP toxicology studies.
The purpose was to ensure the maximum tolerated dose of Apta-1 as part of the regulatory-controlled pre-clinical safety program for the drug candidate Apta-1. The conducted studies are so-called "dose range finding" studies in the two animal species rat and primate (NHP – non human primate). In preparation for studies in human, repeated treatments have been studied for the safety of dosages much higher than what is expected to be given to patients. Results from the studies confirm that doses up to 200 mg/kg/day in rat and 135 mg/kg/day in primate respectively showed a very good safety.
Aptahem's CEO, Mikael Lindstam, comments: "We are very pleased with the results from the studies as it underlines what we anticipated. That the malaria parasite, through evolution, refined the molecular template that led to the distillation of the blocker molecule Apta-1. Paradoxically, the conclusion about our good safety profile means that our current substance need results in a delay of our previously communicated timeline."
Planning is ongoing for manufacturing of more substance for Aptahem to start the next step in the pre-clinical program, including regulatory GLP toxicology studies. The planned start of clinical trials in humans is estimated for the third quarter of 2019.
For further information:
Mikael Lindstam, CEO, Aptahem AB
Tel: + 46 (0)766-33 36 99
E-mail: ml@aptahem.com
This information is 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 contact persons above, for publication on October 10, 2018.
Forward-looking statements
This communication contains forward-looking statements, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their nature, as is research and development work in the biotechnology segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios as described in this press release.
About Aptahem
Aptahem AB (APTA) is a biotechnology company that develops aptamer-based pharmaceuticals for the treatment of life-threatening conditions in which a combination of coagulation and inflammation are involved. The company’s primary pharmaceutical candidate, Apta-1, is being developed with the aim of preventing the high mortality rate caused by organ and tissue damage in sepsis patients, among others. The company possesses patent protection in strategic target markets and actively seeks business development opportunities with potential collaborators.
Tags: