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| Land | Sverige |
|---|---|
| Lista | Spotlight |
| Sektor | Hälsovård |
| Industri | Bioteknik |
Aptahem AB (publ) announces today that the final study report from the GLP (Good Laboratory Practice) toxicology and safety studies has been finalized. The report confirms the previously communicated preliminary results regarding positive safety profile for Apta-1. The GLP tox studies are mandatory parts of the preclinical program to enable approval from the authorities to go into clinic. After performing a thorough analytical work on the data, Aptahem confirms that the lead candidate Apta-1 was well tolerated within the dose window.
Aptahem has now finalized the parts of the preclinical program required to 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 5 and 7 days, respectively, treatment in two species.
CEO Mikael Lindstam comments:
"We are very pleased, after a very long period of compiling the final report, to see that the results confirm the preliminary results and what we have seen since the start of our toxicology and safety studies. I am also very pleased to see that Apta-1 was very well tolerated within the planned dose window, which is promising for the clinical studies where we will study safety in humans as well as indicative therapeutic effect from a provocation study model in healthy volunteers. We are now getting close to finalizing the documentation to be filed to the authorities and with the final report from the GLP tox we will soon have the full package of background data. We are now looking forward to putting all the remaining small pieces in place to be able to move into clinic as soon as possible."
With the finalization of the report from the GLP tox studies all parts of the preclinical program have been fulfilled, including a manufactured and delivered GMP (Good Manufacturing Practice) drug substance batch. The company is now fully focused on compiling the documentation needed to file an application to the authorities for starting the clinical study.
For further information:
Aptahem AB
Mikael Lindstam, CEO
Tel: +46 (0)766-33 36 99
E-mail: ml@aptahem.com
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.