- Antisense Therapeutics (ANP) has submitted a paediatric investigation plan to the European Medicines Agency Paediatric Committee for its muscular dystrophy drug
- The submission will allow Antisense to confirm the design of a phase 2b clinical trial and receive feedback for an upcoming application
- CEO Mark Diamond says the submission is a major step for the drug as a potential treatment for patients with Duchenne muscular dystrophy
- Antisense is now manufacturing the drug’s active ingredient for the trial and is planning to have this formulated into an injectable product in the June quarter
- Company shares are up 5.88 per cent and are trading at 18 cents
Antisense Therapeutics (ANP) has submitted a paediatric investigation plan (PIP) to the European Medicines Agency (EMA) Paediatric Committee (PDCO).
The submission was made for the development of Antisense’s ATL1102 drug for Duchenne muscular dystrophy (DMD).
Essentially, a paediatric investigation plan is aimed at ensuring the necessary data is obtained to support the authorisation of a medicine for children.
The PIP submission includes a planned phase 2b clinical trial of ATL1102 that will include non-ambulant DMD patients and will be conducted in Europe.
The submission will also allow Antisense to confirm the design of the trial and receive feedback from the PDCO for the application of the trial.
“By commencing the formal EMA process to establish the clinical and commercial path for ATL1102 in Europe, the world’s 2nd largest pharmaceutical market, the PIP submission represents a major step in the advancement of ATL1102 as a potential treatment for DMD patients in that region,” CEO Mark Diamond said.
Once patients are recruited, they’ll be dosed with the muscular dystrophy drug for 12 months at two levels. Further details will be outlined once Antisense gets feedback and has submitted its trial application.
Antisense is now manufacturing the ATL1102 active ingredient for the trial and is planning to have this formulated into an injectable product in the June quarter.
Company shares are up 5.88 per cent and are trading at 18 cents at 10:40 am AEDT.