Lead site for Innate's SPMS trial wins ethics nod

The Western Australian Neuroscience Research Institute (WANRI) has secured approval to start recruiting patients for a phase IIb trial of Innate Immunotherapeutics’ (ASX:IIL) MIS416 candidate in secondary progressive multiple sclerosis (SPMS).

Independent ethics review board Bellberry Human Research Ethics Committees has signed off on the design of the trial. The first patients are now expected to be dosed within the next 2-3 weeks.

The trial will recruit up to 90 patients across multiple Australian sites. The design calls for 60 patients to receive MIS416 and 30 to receive a placebo. Treatment will be administered weekly for 12 months.

The trial’s primary endpoint is to determine the efficacy and safety of the treatment candidate against the placebo.

WANRI will be the lead site for the trial. Innate said that approval at key sites in the eastern states is expected to be granted in the next few months.

Innate separately revealed it finished the quarter ending in June with a cash balance of $6.17 million. Operating cash burn for the quarter was $1.73 million.

Spending during the quarter included a $1 million pre-payment to INC Research, which has been selected to manage the MIS416 trial.

MIS416 is a biologically derived immune modulator shown to target the regulatory and pathogenic functions of the innate immune system. It targets myeloid cells, which can remodel deregulated immune activity - an important part of the disease progression of SPMS.

Innate Immunotherapeutics (ASX:IIL) shares were trading 2.5% higher at $0.205 as of around 2.30 pm on Tuesday.