- Antisense Therapeutics (ANP) is set to enter discussions with the U.S. Food and Drug Administration (FDA) to develop its muscular dystrophy drug in the U.S
- ANP is set to meet with the federal agency in April 2021 to clarify pre-clinical requirements and determine the next steps for developing ATL1102 in the U.S.
- The drug seeks to provide treatment for Duchenne muscular dystrophy patients, by inhibiting a cell-type associated with more severe and rapid progression of the disease
- Investors are set to receive an update in May 2021, upon receipt of formal minutes of the meeting
- Antisense shares are up 2.22 per cent on the market, trading at 23 cents each
Antisense Therapeutics (ANP) is set to enter discussions with the U.S. Food and Drug Administration (FDA) to develop its muscular dystrophy drug in the U.S.
The Australian pharmaceutical player has been granted a Type C guidance meeting with the federal agency, scheduled for April 19, 2021.
As part of the meeting, Antisense will gear the discussions towards developing its ATL1102 treatment in Duchenne muscular dystrophy (DMD) in the U.S. by determining preclinical requirements and concluding with “guidance on the path forward.”
The ASX-lister is also requesting the FDA consider allowing data from previously conducted monkey toxicity studies and recently obtained data from a six-month clinical safety trial to support the longer-term dosing of ATL1102 in DMD patients in the US.
DMD is caused by a mutation in the muscle dystrophin gene leading to severe progressive muscle loss and premature death and is considered one of the most common fatal genetic disorders.
There is currently no cure for the x-chromosome disease, and treatment often includes anti-inflammatory medications that are acknowledged as providing insufficient efficacy and are associated with significant side effects.
As a result, it is widely held there is a high unmet need for new therapeutic approaches to treat inflammation associated with DMD.
ANP’s ATL1102 treatment acts as an inhibitor of CD49d, a cell associated with both more severe and rapid disease progression.
“We look forward to our meeting with FDA to confirm the regulatory pathway for ATL1102 in DMD to bring this much needed new therapy to DMD patients in the U.S.,” Antisense Therapeutics Chief Executive Mark Diamond said.
Antisense expects to provide an update in late May 2021 upon receipt of formal minutes of the meeting.
Antisense shares are up 2.22 per cent on the market, trading at 23 cents each at 11:35 am AEDT.