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Innate Immunotherapeutics Announces FDA Clearance Received for MIS416 Investigational New Drug Application

Innate Immunotherapeutics Limited (ASX Code:IIL) is pleased to confirm it has received clearance from the U.S. Food and Drug Administration (FDA) for the Company's Investigational New Drug (IND) application lodged last month.

The successful opening of an IND in the U.S. is a further important milestone in the ongoing clinical development of the Company's lead drug candidate MIS416.

MIS416, a novel modulator of innate immunity, recently completed a Phase 2B safety and efficacy trial in patients suffering from secondary progressive multiple sclerosis (SPMS). The study was conducted at five sites in Australia and two sites in New Zealand. The company has previously advised that the trial results are expected in the third quarter of this year.


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