- Antisense Therapeutics (ANP) commences the dosing stage of a nine-month chronic monkey toxicology study of its ATL1102 treatment in the US
- The toxicology study is expected to support the advancement of ATL1102 for the potential treatment of Duchenne muscular dystrophy (DMD)
- Antisense says the completion of the toxicology study should be the final requisite step for the US FDA to allow dosing of the product for a term longer than six months
- The study should complete animal dosing by November this year, with results to be released in the first half of 2024
- ANP shares are down 4.26 per cent and trading at nine cents at 12:23 pm AEDT
Antisense Therapeutics (ANP) has commenced the dosing stage of a nine-month chronic monkey toxicology study of its ATL1102 treatment in the US.
The study is expected to support the advancement of ATL1102 for the potential treatment of Duchenne muscular dystrophy (DMD).
If successful, ANP can apply for an expedited program status with the US Food and Drug Administration (FDA) for a potential Breakthrough Therapy designation for ATL1102.
Further, Antisense said the toxicology study should be its final requisite step before the FDA can allow the dosing of ATL1102 for longer than six months.
The study is expected to complete animal dosing by November this year, with results released in the first half of 2024.
Around the same time, results from ANP’s blinded ATL1102 phase IIb DMD clinical study will also be made public.
ANP said it intended to share a “compelling” data package of clinical and toxicology results with the FDA and other regulatory bodies so that conversations around the acceleration of the regulatory pathways of ATL1102 to registration could be discussed.
Additionally, subject to meeting the eligibility criteria, ANP may also be in a position to receive a future Pediatric Review Voucher (PRV).
The price paid for PRVs ranges between US$95 million and US$110 million (A$143 million and A$165 million).
ATL1102 is a type of medication that works by stopping the production of a protein called CD49d, which is part of a molecule called VLA-4.
This protein is known to contribute to inflammation in the body and has been linked to conditions like asthma and multiple sclerosis (MS).
Studies conducted on animals have shown that using ATL1102 can effectively reduce inflammation associated with these conditions.
Additionally, a phase IIa clinical trial conducted on patients with relapsing-remitting MS showed that ATL1102 was highly effective in reducing MS lesions.
ATL1102 is currently the only medication in clinical development that specifically targets CD49d and is being tested for its potential use in treating Duchenne muscular dystrophy (DMD).
The US FDA has already granted ATL1102 Orphan Drug Designation and a Rare Pediatric Disease Designation for treating DMD.
ANP shares were down 4.26 per cent and trading at nine cents at 12:23 pm AEDT.