The US FDA has lifted its full clinical hold for Antisense Therapeutics' (ASX:ANP) Phase IIb study of ATL1102 for Multiple Sclerosis.
The study may now proceed at a low (25mg/week) dose for 6 months under a partial hold introduced by the US regulator.
"The Company in consultation with its regulatory advisors will now seek clarification from the FDA for criteria under which MS patients could receive higher doses in subsequent trials with the provision of an adequate safety monitoring plan to allow for higher dosing which is the reason for the dosing restriction under the current IND," said Antisense in a statement.
The company also announced its application to conduct a clinical trial of ATL1102 in patients with Duchenne Muscular Dystrophy (DMD) at the Royal Children’s Hospital in Melbourne has been approved to move forward by the Human Research Ethics Committee (HREC) subject to clearance of ATL1102 for MS Phase IIb IND by the FDA.