Table 2. Summary of the 14-day repeated-dose toxicity study in minipigs with full-thickness wounds with a 14-day recovery period.

Species/strain	Göttingen minipigs
Initial age	9–12 months
Dose levels	0 CFU/ml, 5x107 CFU/ml, 5x109 CFU/ml
Duration of dosing	14 days, treatment on every other day
Duration of Postdose	14 days
Method of administration	Topical on wounds
Vehicle/Formulation	5% dextrose, 2.5 sodium chloride, 1.6% sodium acetate
GLP Compliance	Yes
Parameters controlled	Body weight, food consumption, body temperature, clinical observations, opthalmoscopy, electrocardiography, haematology, clinical chemistry, urinalysis, organ weight, gross pathology, histopathology
Special feature	Biodistribution and macroscopic wound evaluation
Brief conclusion	Topical administration with 5x107 and 5x109 CFU/ml of AUP1602-C in surgically established full thickness wounds at 7 occasions during a time span of 14 days was well tolerated and did not cause any treatment releated systemic changes in male and female Göttingen minipigs. All wounds healed as normal and the wound healing process was advanced in all wounds at the end of the main study period and the recovery period.
NOAEL	1x109 CFU/ml
Dose (CFU/ml)	0 (Control)	5x107	5x109	0 (Control)	5x107	5x109
Number of animals	M: 5	M: 5	M: 5	F: 5	F: 5	F: 5
Number of wounds	4	4	4	4	4	4
Noteworthy findings	No noteworthy findings wound in the study