New sepsis data indicates very good efficacy in Apta-1 treated primates
Aptahem (publ) announce today that the extended exploratory sepsis study in primates has shown positive results. This increases the hope of being able to show good efficacy also in upcoming and more extensive confirmatory studies.
After the company announced that the non-regulated GLP toxicology study showed a higher dosage range than expected at the end of August 2018, the company decided to extend their already initiated NHP (Non Human Primate) 3-day efficacy study with higher dosages of Apta-1. The sepsis model was redesigned to achieve increased inflammatory response through an increased dosage of lipopolysaccharide (LPS), a substance causing a sepsis-like reaction in the animal. The study was recently concluded and now follows extensive analysis of the collected data. A final report will come later but the company can already now share preliminary results reported to date.
Observations in the group without Apta-1 in animals who only received LPS show pronounced apathy, very low appetite, difficulties with breathing and no signs of recovery. Deaths were even reported. Observations in animals which had been given LPS and subsequently been treated with Apta-1 initially showed signs of severe inflammation but, behaviorally, were more active and on the last day (day 3) returned to more normal activity through renewed appetite, increased mobility and restoration of bodily functions. All animals treated with Apta-1 survived. Biomarkers analyzed to study damage on a number of vital organs, indicate positive trends in the animals that has been given Apta-1.
Anders Bylock, chief medical officer (CMO) at Aptahem comments “Aptahem has in a series of studies in primates (NHP) developed a new model for experimental sepsis where the chemical exposure for LPS has increased to the extent that the model has become very similar to the clinical situation for humans. With this new unique sepsis regimen, severe loss of appetite, inner organ damage and deaths within three days are noted if no protective medicine is given. It is, therefore, very stimulating and encouraging to already at this early stage note that primates that received Apta-1 after LPS-injection showed a much less impacted clinical image, especially during the last, third, day when a notable recovery could be registered through the clinical markers that we have analyzed so far. Results from the more extensive confirmatory studies are awaited with great excitement as positive results would give clear motivation for entering clinical studies in patients as soon as possible.”
“Our extended exploratory study with the newly developed sepsis model showed stimulating results indicating that Apta-1 has a good efficacy in primates. These results indicate that Apta-1’s unique multifunctional profile and the studies’ increased dose escalation gives the desired outcome,” says Mikael Lindstam, CEO of Aptahem. “We are very positive to the continued development of Apta-1 and our focus is on bringing Apta-1 into clinical studies.”
For further information:
Mikael Lindstam, CEO, Aptahem AB
Tel: + 46 (0)766-33 36 99
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 November 14, 2018.
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 communication.
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.