- Antisense Therapeutics (ANP) receives approval to conduct its phase two trial in non-ambulant boys with Duchenne muscular dystrophy (DMD) in Turkey
- The approval came from the Turkish Medicines and Medical Device Agency to conduct a double-blind, placebo-controlled trial of ATL1102
- This marks the company’s first trial approval by a regulatory authority
- The company expects further trial approvals in Bulgaria, the UK and Australia, depending on each regulatory agencies’ evaluation process and timelines
- Antisense Therapeutics last traded at 9.6 cents on February 13
Antisense Therapeutics (ANP) has gained the tick of approval to conduct its phase two trial in non-ambulant boys with Duchenne muscular dystrophy (DMD) in Turkey.
Duchenne muscular dystrophy is a genetic disorder which results in ongoing deterioration in muscle strength and muscle degeneration. With no intervention, the average life span of a person suffering DMD is 19 years.
The approval came from the Turkish Medicines and Medical Device Agency (TMMDA) to conduct a double-blind, placebo-controlled trial of ATL1102.
Antisense was required to submit a clinical trial application to gain the approval for trials in the UK, Bulgaria and Turkey. The news marks the company’s first trial approval by a regulatory authority which ANP said is an “important milestone” to affirm the quality of the study’s design.
Coordinating Principal Investigator of the trial Professor Thomas Voit said receiving the first regulatory authority approval was “very pleasing” and he was particularly enthusiastic to have Professor Haluk Topaloğlu as the National Coordinating investigator.
“This is great news not only for the prospects of our phase IIb trial but also for the Duchenne patients who remain in great need of effective and safe therapies,” Mr Voit said.
The study will enrol and randomise 45 non-ambulant boys with DMD from multiple clinical trial sites across Europe and Australia.
Following the initial six-month regimen of either placebo, 25 milligrams or 50 milligrams of ATL1102 once weekly, participants will continue into a further six-month open label treatment period.
The company said trial approvals in Bulgaria, the UK and Australia are expected to come through in a “staggered manner,” depending on each regulatory agencies’ evaluation process and timelines.
Antisense Therapeutics last traded at 9.6 cents on February 13.