EC313 development stages
EC313 chemical structure has been optimized to avoid toxicities encountered with other SPRMs and particularly liver toxicity. EC313 has been structurally engineered to possess high oral bioavailability. Drug development of EC313 is being pursued in four phases:
- conduct supportive pharmacological and endocrine studies to establish full characterization of EC313,
- conduct safety pharmacology, and toxicology studied required for regulatory approval by regulator,
- formulation development and filing of regulatory application to initiate human clinical Phase I study, and finally.
- Conduct a Phase I clinical study to evaluate pharmacokinetics, surrogate markers, and initial safety in humans.
After concluding the aforementioned drug development phases, Evestra Onkologia will establish a corporate partnership to continue clinical development and commercialize EC313.