PARIS--(BUSINESS WIRE)--Acticor Biotech, a clinical stage biotechnology company involved in the acute phase of thrombotic diseases, including stroke and pulmonary embolism, has discussed with the European Medicines Agency (EMA) the development of its drug candidate, ACT017. This meeting follows the completion of the first-in-human study in January 2018 which provided preliminary positive results especially in bleeding time and dose effect in platelet aggregation inhibition.
The discussion meeting took place in London on March 6th, 2018. Acticor Biotech provided a list of questions concerning the non-clinical development, including pharmacology and toxicology studies in animals, and the clinical development of ACT017.
The final advice given by the Committee for Medicinal Product for Human use (CHMP) based on the questions and supporting discussion was very positive.
It was acknowledged that further studies in animal stroke models are not likely to add conclusive information given the lack of available models that adequately mimics ischemic stroke and, hence, are not warranted at this stage of development.
Given the data presented, the non-clinical pharmacology and toxicology studies seems sufficient to support future marketing authorization.
The proposal to initiate a first-in-patient study appeared justified to the Agency, the phase IIa study design with ACT017 administered in association with standard of care was discussed such as thrombolysis and thrombectomy. Although national authorities remain the competent authorities for clinical trial authorisation, the feedback was constructive and allowed to refine endpoints and selection criteria.
Analysis of pharmacokinetics and pharmacodynamics (PK-PD) results from Phase I are ongoing and the final report of the study is due in the coming weeks. Once full results are available, the protocol for the phase IIa study will be finalized. As such, Clinical Trial Authorization (CTA) application for Phase IIa in stroke patients in several European countries is planned for Q3 2018.
About ACT017, the Therapeutic Candidate - https://acticor-biotech.com/technology/
About Acticor Biotech - https://acticor-biotech.com/