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Positive results in animal toxicology tests with Phal-501

The pilot animal toxicology study with Phal-501 in mice has now been completed. The study was conducted according to the following plan:
Number of animals: 6 mice received treatment and 3 mice were in the control group.
Dose: The animals received a dose about 10 times higher than the highest dose planned in humans.
Dosage: The test animals received two doses of Phal-501 orally (by mouth) daily for three days, totaling 6 doses.
Parameters:
Body weight during the study.
Assessment of animal behavior for 30 min after each dose to identify any adverse reactions.
Stool consistency and appearance at the study’s end.
Microscopic assessment of histological preparations stained with Hematoxylin and Eosin from the small and large intestines to identify possible irritant/inflammatory effects of Phal-501.
Results:
No change in body weight of any animal in the study.
No indication of adverse reaction in any animal in the study during 30 min after dose.
Normal stool consistency/appearance for all animals at the study’s end.
Histological assessment showed normal epithelium (mucosa) in all animals. No sign of infiltration of inflammatory cells in the tissue of any animal to indicate an inflammatory reaction.

CEO Staffan Skogvall: These animal toxicology tests clearly show that Phal-501 does not exhibit any adverse effects in the gastrointestinal tract of a mammal (mouse). There is, therefore, every reason to believe that Phal-501 will also be very well tolerated in humans in future clinical studies! We could not have wished for a better outcome from this animal study!