Antisense Therapeutics (“ANP” or the “Company”) wishes to advise that it has received notification from the US Food and Drug Administration (FDA) that the full clinical hold for the Phase IIb clinical study of ATL1102 for Multiple Sclerosis (MS) has been lifted and that study may proceed at a low (25mg/week) dose for 6 months under a partial hold introduced by the FDA.
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. The Company will provide a further update on its plans and timings in this regard, as soon as practical.
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