Dose Range-Finding Toxicity Study in Rats With Recombinant Human Lactoferrin Produced in Komagataella phaffii

The oral toxicity of recombinant human lactoferrin (rhLF, Helaina rhLF, Effera™) produced in Komagataella phaffii was investigated in adult Sprague-Dawley rats by once-daily oral gavage for 14 consecutive days. Vehicle control received sodium citrate buffer; test groups received 200, 1000, and 2000 mg rhLF/kg body weight/day, with bovine LF at 2000 mg/kg/day as a comparative control. Clinical observations, body weight, hematology, clinical chemistry, iron parameters, immunophenotyping, and gross necropsy were assessed, along with LF bioavailability. Administration of Helaina rhLF by once-daily oral gavage for 14 days was well tolerated in rats at levels up to 2000 mg/kg/day (57x Helaina's intended commercial adult use), indicating this high dose is appropriate for future definitive toxicology studies.