Antisense Therapeutics (ASX:ANP) says the US FDA has granted a 'Type C' guidance meeting that has been scheduled for 19 April 2021.
The company said the purpose of the meeting is to discuss the further development of ATL1102 in Duchenne muscular dystrophy (DMD) in the US. It said it expects to provide an update in late May 2021 following receipt of the official minutes of the meeting.
Antisense said it is working with its US-based regulatory consultants with the goal of clarifying via the meeting the preclinical requirements to support the clinical development of ATL1102 in the US in DMD patients.
The company said it will use the meeting to request that the FDA consider allowing the data from previously conducted six-month monkey toxicity studies and recently obtained six-month (24 weeks of dosing) clinical safety data in non-ambulant DMD patients, to support the longer-term (12-month) dosing of ATL1102 in DMD patients.
Mark Diamond, CEO of Antisense Therapeutics, said: ”In parallel with our preparations for the conduct of the Phase IIb study in Europe planned to be launched in 2H’21, 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 US”.