- Immunoprecise Antibodies Ltd (NASDAQ:IPA) has reported preclinical data of PolyTope TATX-03 antibody cocktail therapy against COVID-19.
- The IND-enabling animal studies did not show any observable acute adverse events and supported a favorable safety profile.
- As a prelude to a formal toxicology study, a maximum tolerated dose and a pharmacokinetic study was completed using injections of up to 12.5 times the anticipated highest dose proposed for the phase 1 trial.
- The results did not demonstrate any adverse clinical signs or any observable effect in behavior, appetite change, or weight change in any animals.
- Related: ImmunoPrecise's COVID-19 Antibody Cocktail Shows Neutralization Activity Against Omicron.
- The FDA has advised examining the build-up of antibody serum concentrations in the laboratory animal model versus humans, recommending a study design adaptation to increase the number of injections and monitor the elimination of antibodies from the animals.
- Therefore, the ongoing final GLP toxicology study is extended by eight weeks, with the final data being available in mid-June 2022.
- The Company expects Investigational New Drug (IND) filing to the FDA in early Q3.
- Price Action: IPA shares are down 5.77% at $3.92 during the market session on the last check Wednesday.
