Dosing for all animals will be completed in November witAntisense (ASX:ANP) has announced the start of a nine-month chronic monkey toxicology study of ATL1102. The study aims to support advancement of the ATL1102 program in the US for the treatment of Duchenne muscular dystrophy (DMD) or any other clinical application of ATL1102.Dosing for all animals will be completed in November with outcomes expected to be reported in H1 CY24. Power said the toxicology study is the key to unlock therapeutic use of ATL1102 in the US. Successful completion is expected to be the final step required by the FDA to allow dosing of ATL1102 for more than six months in the US and enable ANP to apply for expedited program status with the FDA, including fast track or potential breakthrough therapy designation.“This is an important step in terms of what will be required by the regulators for ultimate approval,” Power said.h outcomes expected to be reported in H1 CY24.
Power said the toxicology study is the key to unlock therapeutic use of ATL1102 in the US. Successful completion is expected to be the final step required by the FDA to allow dosing of ATL1102 for more than six months in the US and enable ANP to apply for expedited program status with the FDA, including fast track or potential breakthrough therapy designation.
“This is an important step in terms of what will be required by the regulators for ultimate approval,” Power said.
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