Innate to start recruiting for SPMS trial in June
Innate Immunotherapeutics (ASX:IIL) is gearing up for a phase IIb trial of drug candidate MIS416 in secondary progressive multiple sclerosis (SPMS) and plans to start recruiting patients in late June.
The company plans to enrol up to 90 patients across eight Australian clinical sites for the double-blinded trial.
Patients will be randomised so that 60 receive MIS416 and 30 will receive a placebo. At the end of the trial, both groups will be offered continued access to the drug under an extension protocol.
The study will focus on assessing the efficacy of the treatment, as gauged by clinical measures of neuromuscular function as well as patient-reported outcomes.
Key measures will be SPMS’s effect on walking, hand function, eyesight and cognition, as well as patients’ daily activities and quality of life.
Innate CEO Simon Wilkinson said taking multiple measures of treatment outcome will “allow us to select the right measures, and determine the correct number of patients, to take into a subsequent phase III approval trial”.
Innate raised $10 million through an IPO in December and plans to use $6 million of the proceeds to fund the trial. The company has engaged CRO INC Research to help execute the study.
Innate Immunotherapeutics (ASX:IIL) shares were trading 2.38% lower at $0.205 as of around 1.30 pm on Wednesday.
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