Antisense Therapeutics (ASX:ANP) says it has received confirmation of two of the three proposed Scientific Advice (SA) meetings for its planned interactions with regulatory authorities to progress the design and conduct of the next clinical trial of ATL1102 in Duchenne muscular dystrophy (DMD).
"The first meeting is confirmed for end of October with the second meeting scheduled for November and confirmation of the third meeting anticipated within the coming weeks," said the company.
Antisense said it had previously received advice from international regulatory consultants that, based on the existing preclinical and clinical data generated in the development of ATL1102, it could look to seek approval to conduct a Phase 2b clinical trial of the drug in DMD patients in Europe. It said this regulatory process would run in parallel with the current Phase 2 study of ATL1102 in DMD patients at the Royal Children’s Hospital in Melbourne.
It said the focus of these SA meetings will be on the Phase 2b trial design, dose-escalation plans, the applicability of the study end-points and the study duration.
It will then seek advice from the European Medicines Agency (EMA) with the goal of receiving its acceptance of the overall development program for ATL1102 in DMD.
According to Antisense CEO, Mark Diamond, “We are pleased to confirm this important step of the commencement of regulatory interactions necessary to ensure efficient and timely advancement to the next stage of development of ATL1102 in DMD and we look forward to reporting on the progress of these interactions in due course."