Dosing commenced in the ATL1102 toxicology study
In March 2023 the Company announced the start of the nine-month chronic monkey toxicology study of ATL1102 for treatment of Duchenne muscular dystrophy (DMD). Dosing of all animals will be completed by November 2023 with study outcomes expected to be reported in the first half of 2024. Successful completion of the toxicology study is necessary for the FDA to allow dosing of ATL1102 for a term longer than six months in the US, and could lead to expedited program status, including Fast Track or Breakthrough Therapy designation.
ANP has already been granted Orphan Drug Designation and Rare Pediatric Disease Designation by the FDA for the treatment of DMD, and the completion of the toxicology study could pave the way for discussions on accelerated regulatory pathways to registration. The Company may also be eligible to receive a Pediatric Review Voucher (PRV), subject to meeting the eligibility criteria, which could have significant financial value.
The reporting of key study findings from the toxicology study in 1H’24 is expected to coincide with the results from the blinded phase of the ATL1102 Phase IIb DMD clinical study. If the results of both studies are compelling, ANP could share the data package with regulatory bodies for potential discussions on accelerated regulatory pathways to registration.
