Piasky: which tox species, and why?

“Crovalimab was evaluated in good laboratory practice-compliant acute and chronic (6-month) toxicology studies in cynomolgus monkeys, which is the only pharmacologically-relevant species.”

“Crovalimab binds human C5 (hC5) and cynomolgus monkey C5 (cyC5) to the same extent (1.72 and 2.00 ×10-10 mol/L, respectively) and its binding is pH dependent. No binding to rat C5 (rC5) and a weak binding to mouse C5 (mC5) were detected.”

“The non-clinical toxicology programme of crovalimab characterised general toxicity and toxicokinetics following IV and SC administrations up to 26 weeks in a single pharmacologically relevant species (cynomolgus monkeys), as recommended in ICH S6(R1) guideline.”

“Crovalimab was evaluated in good laboratory practice-compliant acute and chronic (6-month) toxicology studies in cynomolgus monkeys, which is the only pharmacologically-relevant species.”

“Since the cynomolgus monkey was the only demonstrated pharmacologically relevant species, an enhanced pre- and postnatal development (ePPND) study was conducted in line with ICH S6(R1) guideline. An assessment of the reproductive organs was also included in the repeat-dose toxicity studies to address any potential effect on fertility.”

“Crovalimab is not active in rodents; therefore, carcinogenicity studies are not feasible.”

“The non-clinical toxicology programme of crovalimab characterised general toxicity and toxicokinetics following IV and SC administrations up to 26 weeks in a single pharmacologically relevant species (cynomolgus monkeys), as recommended in ICH S6(R1) guideline.”