Innate Immunotherapeutics’ MS drug to go to second trial

Innate Immunotherapeutics’ MS drug to go to second trial

Auckland, NZ, June 19 2012: New Zealand biopharmaceutical company Innate Immunotherapeutics says trials of its drug to help people with chronic, progressive multiple sclerosis (MS) are showing positive results.

Simon Wilkinson, chief executive of Innate Immunotherapeutics, says results of the Phase 1/2 clinical trial have shown MIS416 to be well tolerated and identified a clinical dose for further evaluation.

MIS416 is the lead product from the Auckland-based biopharma’s proprietary immune modulating microparticle technology.

Neurologist Professor Tim Anderson, co-principal investigator for the study, says the preliminary data indicate that MIS416 was safe and well tolerated. The MS-related clinical status assessment tools used during the study also indicate that the trial agent may have had some positive effect for many of the treated patients.

During the dose confirmation portion of the study, eight of 10 patients with secondary progressive MS treated with MIS416 for 12 weeks showed some improvement in their MS-related signs and symptoms.

“For example, 50% of the study subjects showed some improvement in EDSS scores over the relatively short 12 week duration of the trial,” Professor Anderson says. “These interim results are encouraging and merit the consideration of a randomised, controlled trial in patients with secondary progressive multiple sclerosis."

Innate Immunotherapeutics expects to complete the current Phase 1/2 study and announce final results in late 2012. It then plans to enroll MS suffers in 2013 for a 12 month Phase 2B study to investigate the sustainability of the improvements in seen in the first study.

“We plan to conduct most of the next study in Australia, to take advantage of that country’s greater patient availability and the financial support offered by the Australian government,” Mr Wilkinson says. “If we can get appropriate local support it would be good to also have trial sites in New Zealand.”
Rosie Gallagher, National Director, Multiple Sclerosis Society of New Zealand, says the research is an exciting and extremely positive move.

“Disease modifying therapies for those with MS tend to be of the immune-suppressant variety and are specifically for those with the relapsing-remitting form of the disease,” she says. “However, these treatments have little to no effect on secondary progressive MS patients. This is a worry for the future, as around 75% of those with the relapsing-remitting form of the disease will eventually move into being classified as secondary progressive.

“We welcome and encourage more research into MIS416, which, as well as potentially offering relief to those with this debilitating chronic illness, also gives hope to those with secondary progressive MS in that they may finally have a tangible symptomatic treatment option.”

In addition to financial support from the New Zealand Ministry of Science and Innovation, Innate Immunotherapeutics also has the support of the United States-based National Multiple Sclerosis Society. The society’s venture capital arm, Fast Forward, accelerates the development of treatments for MS by connecting university-based MS research with private-sector drug development and by funding small biotechnology/pharmaceutical companies to develop innovative new MS therapies and repurpose FDA-approved drugs as new treatments for MS.

Dr Timothy Coetzee, Chief Research Officer at the National Multiple Sclerosis Society, says it is pleased to help advance Innate's important research, which is designed to speed the development of an effective treatment for secondary progressive MS.

Innate Immunotherapeutics is also collaborating with New Zealand and US universities that specialise in oncology research, to conduct preclinical studies of MIS416 in other applications, including treatment vaccines for a number of different cancers.

About MIS416
MIS416 is the lead product from Innate Immunotherapeutics’ proprietary immune modulating microparticle technology. The technology is based on the use of a bacterially derived, therapeutic microparticle incorporating multiple naturally occurring ligands, which when administered can activate synergistic innate immune signalling pathways to down regulate chronic inflammation, reduce autoimmune factors and help repair damaged tissue. In addition to its potential use in MS, the company is conducting preclinical studies of MIS416 in other applications, including oncology co-therapy and the treatment of infectious diseases.

About Secondary Progressive Multiple Sclerosis
MS is a chronic, unpredictable neurological disease that affects the central nervous system. It is thought to be an autoimmune disorder, meaning the immune system incorrectly attacks healthy tissue. Symptoms may be mild, such as numbness in the limbs, or severe such as paralysis or loss of vision. About 85% of patients with MS are initially diagnosed with a relapsing-remitting form of the disease, characterized by clearly defined attacks of worsening neurologic function. There are currently eight disease modifying therapies approved to treat relapsing-remitting MS (RRMS). Subsequently more than 65% of these patients enter a second phase of their illness, called secondary progressive MS, wherein symptoms progressively get worse, with or without occasional acute symptom flare-ups. There are no effective therapies currently approved for the ongoing treatment of secondary progressive MS.

About Fast Forward, LLC
Fast Forward, LLC, established by the National Multiple Sclerosis Society as part of a comprehensive approach to MS research and treatment, focuses on speeding promising research discoveries towards commercial drug development. Fast Forward accelerates the development of treatments for MS by connecting university-based MS research with private-sector drug development and by funding small biotechnology/pharmaceutical companies to develop innovative new MS therapies and repurpose FDA-approved drugs as new treatments for MS. For more information, please visit http://www.fastforward.org.

About Innate Immunotherapeutics
Innate Immunotherapeutics Limited is a public unlisted biopharmaceutical company based in Auckland, New Zealand. The company is focused on the development of a new generation of immune response modifiers for potential use in the treatment of MS and other autoimmune diseases, a range of infectious diseases, certain cancers, and as a novel cellular and humoral adjuvant. For further information on the company, please visit our website at http://www.innateimmunotherapeutics.com/

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