- Antisense Therapeutics (ANP) says it has received positive feedback received on the Paediatric Investigation Plan (PIP) for its ATL1102 treatment
- The feedback came from the European Medicines Agency, as ANP pushes ahead with the development of the drug for Duchenne Muscular Dystrophy (DMD)
- Next steps will be a meeting where the PIP is set in place, allowing ANP to push ahead with its Phase IIb trial of ATL1102 in non-ambulant DMD boys
- Ahead of the meeting the company is finalising the site evaluations and selections for the conduct of the trial, as well as progressing applications
- Shares in Antisense are up 6.33 per cent at 21 cents each at 1:58 pm AEST
Antisense Therapeutics (ANP) has received positive feedback on its Paediatric Investigation Plan (PIP) for the ATL1102 treatment.
The company said a draft opinion from within the European Medicines Agency recommended the PIP for the development of ATL1102 — ANP’s treatment for Duchenne Muscular Dystrophy.
The feedback comes ahead of a meeting on October 15 where the EMA may formally adopt the draft opinion of the PIP.
ANP has reviewed the draft ahead of the October meeting and said it was not aware of any issues that would impact adoption and the draft appears consistent with the company’s plans for a Phase IIb trial.
If the meeting goes well, Antisense will essentially be able to push ahead with its Phase IIb clinical trial of ATL1102 in non-ambulant DMD boys.
Antisense Therapeutics Director of Clinical and Regulatory Affairs Nuket Desem said she was pleased with the development.
“Receipt of the EMA’s PDCO positive feedback on the PIP is another key step forward in advancing the company’s plans for the conduct of the potentially approvable Phase IIb study of ATL1102 in DMD in Europe, in line with the company’s expectations,” Ms Desem said.
Ahead of the meeting, the company said it was finalising the site evaluations and selections for the conduct of the trial as well as progressing applications.
“With the final opinion due in the coming weeks, we are finalising the site evaluations and selections for the conduct of the trial and progressing preparations of the clinical trial applications for submission to the national competent authorities,” Ms Desem said.
Shares in Antisense were up 6.33 per cent at 21 cents each at 1:58 pm AEST.