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  • Antisense Therapeutics (ANP) says the latest feedback on its upcoming Duchenne muscular dystrophy trial later this year is in line with company expectations
  • The feedback came in response to ANP’s Paediatric Investigation Plan concerning the development of its muscular dystrophy treatment, ATL1102
  • Antisense says it anticipates finalising the trial design later this year
  • In addition, Antisense also reported it had submitted a FastTrack Designation Request to the US Food and Drug Administration for a US trial
  • Antisense Therapeutics shares are up 2.56 per cent and trading at 20 cents

Antisense Therapeutics (ANP) says the latest feedback on its upcoming Duchenne muscular dystrophy trial later this year is in line with company expectations.

The feedback from the European Medicines Agency Paediatric Development Committee was in response to ANP’s Paediatric Investigation Plan for the development of its Duchenne muscular dystrophy treatment, ATL1102.

As part of its review, the committee provided feedback outlining additional
information requirements on the ANP’S planned phase IIb clinical trial in non-ambulant DMD younger males.

Broadly, Antisense affirms feedback on the trial is in line with expectations and anticipates finalising the trial design with PDCO in Q3 CY21.

The company then plans to submit a clinical trial application for the phase IIb trial of ATL1102 to be conducted in Europe shortly thereafter.

In addition, Antisense also reported it had submitted a FastTrack Designation Request to the US Food and Drug Administration after receiving “positive feedback” on the design parameters for a phase IIb/III study in the US.

Antisense Therapeutics Director of Clinical and Regulatory Affairs Nuket Desem said feedback from the European Medicines Agency was constructive.

“We have appreciated the collaborative approach of the EMA to assist us in refining the study design for the proposed Phase IIb clinical trial in Europe,” he said.

“It’s another important step towards bringing this new therapy to patients in the EU.”

Antisense Therapeutics shares were up 2.56 per cent and trading at 20 cents at 12:36 pm AEST.

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