Aptahem’s lead candidate Apta-1 preliminary does not show any toxicity in the GLP tox studies
Aptahem AB (publ) announces today that the GLP (Good Laboratory Practice) toxicology and safety studies preliminary show positive results. The studies are the final part of the preclinical program before an application to start clinical studies can be filed. Preliminary results show that the pharmaceutical candidate Apta-1 was well tolerated within the estimated dose window. A time consuming analytical work will now start to compile all the data from the studies and the company estimates to be able to communicate the final reports later in 2021.
Aptahem has now finalized the practical part of the studies, which preliminary will meet the safety and toxicological requirements of Apta-1 before moving into clinic. The study protocol has followed the previous non-GLP toxicology studies where the company looked at various dose levels during 14 days treatment in two species. The dose window is preliminary large and will potentially make it possible to meet future dose levels to achieve a therapeutic effect.
CEO Mikael Lindstam comments:
”We are very pleased to receive these preliminary results from the studies as they confirm what we already have seen since the start of our toxicology and safety studies. We will now wait for the final reports, which are preceded with extensive analytical work. We are pleased to be able to keep the communicated time plans and are looking forward to moving into clinic as soon as possible.”
The preparations for manufacturing the, for the clinic, necessary GMP (Good Manufacturing Practice) batch is ongoing and follows the time plan as well as other necessary activities to receive approval to initiate clinical studies.
For further information:
Mikael Lindstam, CEO
Tel: +46 (0)766-33 36 99
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.