14th of March 2023Dosing commenced in the ATL1102 toxicology...

14th of March 2023
Dosing commenced in the ATL1102 toxicology study Antisense Therapeutics Limited [ASX:ANP | US OTC:ATHJY | FSE:AWY] (ANP or Company) today announced the commencement of dosing in the nine-month chronic monkey toxicology study of ATL1102. Dosing of all animals will be completed in November this year with study outcomes on track for reporting in 1H’24 as previously advised1. The toxicology study is intended to support the advancement of the ATL1102 program in the US for Duchenne muscular dystrophy (DMD) or any other clinical application of ATL1102. Successful completion of the toxicology study is expected to be the final requisite step for the FDA to allow dosing of ATL1102 for a term longer than six months in the US. Successful completion of the study should also allow ANP to apply for expedited program status with the US Food and Drug Administration (FDA) including Fast Track or potential Breakthrough Therapy designation. US FDA has already granted ATL1102 an Orphan Drug Designation and a Rare Pediatric Disease Designation for the treatment of DMD.