Innate Immunotherapeutics' multiple sclerosis Phase 2B trial on schedule and on budget

Tuesday, April 15, 2014 by Proactive Investors





Innate Immunotherapeutics' multiple sclerosis trial is on schedule and on budget

Innate Immunotherapeutics (ASX:IIL) has confirmed that plans to conduct a Phase 2B trial of its drug MIS416 for secondary progressive multiple sclerosis (SPMS) are progressing smoothly and on budget.



Enrolling of patients at up to eight Australian sites is expected to commence in June this year.



Innate's initial public offering in December 2013 raised $10 million, of which $6 million was earmarked to finance a Phase 2B trial in up to 90 patients with SPMS.



The company has now appointed contract research organization INC Research to assist with the execution of the trial.



INC Research is headquartered in the U.S., with an Australian business unit that has extensive experience running neurology trials.



Patients enrolled into the double blinded study will be randomised such that 60 patients will receive MIS416, and 30 will receive a placebo.



At the end of the study, both groups of patients could be offered continued access to MIS416 under an extension protocol.



Study Details



The study will focus on accessing the efficacy of MIS416 by using several clinical measures of neuromuscular function, backed by patient reported outcomes of treatment effect.



SPMS affects walking, hand, eye sight and cognitive functions, and these disabilities will be measured regularly during the trial.



Further details concerning trial sites, clinical investigators, and patient eligibility, will be released after final approvals have been obtained, expected later in May.



In February, Innate delivered results from animal studies which further support MIS416 as a promising candidate to treat SPMS.



Important support comes from Dr Larry Steinman, a renowned multiple sclerosis specialist at Stanford University, who endorsed the newly published MIS416 therapy validation in animal studies.



A key finding from this study was that MIS416 regulatory activity depended on its ability to induce interferon gamma, a protein which to date has received little attention in the clinical setting.



Multiple Sclerosis is a chronic disease of the central nervous system, where the body’s immune system attacks the myelin sheath surrounding the nerve fibres.



Innate is presently valued at around $35 million.



Analysis



There are currently no safe and effective treatments available to treat SPMS; with an estimated market size of US$2.5-$3.5 billion there is a prize for Innate with its MIS416 treatment. Ongoing "compassionate use" of Innate's drug treatment is a beacon for big pharma and investors.







Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.