Amplia Therapeutics Ltd. (INNMF)

[vegasandre]

Innate Immunotherapeutics’ new drug application gets cleared by FDA

Innate Immunotherapeutics (ASX:IIL) has received clearance from the U.S. FDA for the Investigational New Drug (IND) application lodged last month for its lead drug candidate, MIS416.

MIS416 is a biologically derived novel immune modulator which can uniquely target both the regulatory and defensive functions of the innate (natural) immune system.

Innate recently completed a Phase 2B safety and efficacy trial in patients suffering from secondary progressive multiple sclerosis (SPMS).

The results from the trial, being conducted at five sites in Australia and two sites in New Zealand, are expected in the third quarter of this year.

The successful opening of an IND in the U.S. is an important milestone in the ongoing clinical development of MIS416.

Importantly, it allows the company to meet with the FDA following the release of Phase 2B data, and discuss the design of a Phase 3 study.

Furthermore, Innate can also establish whether MIS416 would qualify for one of the FDA's expedited approval programs which exist to help drugs for serious conditions get to market faster.

Multiple sclerosis (MS) is a chronic disabling condition where the body’s immune system attacks the myelin sheath surrounding nerve fibres.

Within 15 years of being diagnosed with the early 'relapsing-remitting' stage of MS, about 60% of sufferers go on to develop a more advanced progressive form of the disease – SPMS.

There are currently no approved drugs for the effective ongoing treatment of SPMS.

http://www.proactiveinvestors.com.au/companies/news/179611/innate-immunotherapeutics-new-drug-application-gets-cleared-by-fda-179611.html