Innate Announces Interim Results from Phase 2 Study of MIS416 in Secondary Progressive Multiple Sclerosis

AUCKLAND, New Zealand--(BUSINESS WIRE)--Jun 18, 2012 - Innate Immunotherapeutics today announced positive interim data from the company's Phase 1/2 clinical trial of MIS416 in patients with chronic progressive multiple sclerosis (MS). Results of the open-label, dose-escalation/confirmation trial showed MIS416 to be well tolerated and identified a clinical dose for further evaluation. Moreover, during the dose confirmation portion of the study, 8 of 10 patients with secondary progressive MS who were treated with MIS416 for 12 weeks showed some improvement in their MS-related signs and symptoms.

“The preliminary data indicate that MIS416 was safe and well tolerated, and 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,” said neurologist Professor Tim Anderson, M.D., co-principal investigator for the study. “For example, 50% of the study subjects showed some improvement in EDSS scores over the relatively short 12 week duration of the trial. These interim results are encouraging and merit the consideration of a randomized controlled trial in patients with secondary progressive multiple sclerosis.”

Study Design

The aim of the study, conducted in New Zealand, was to evaluate the safety, tolerability and pharmacodynamics of intravenously administered MIS416 in patients with chronic progressive MS. During the dose finding phase, Investigators enrolled a total of 19 patients with primary or secondary progressive MS, 16 of whom completed the study. The subsequent dose confirmation phase treated 11 patients with secondary progressive MS over a 12 week period.

Primary endpoints for the study included safety and tolerability, including maximum tolerated dose and recommended Phase 2 dose, of weekly intravenously administered MIS416, as well as the pharmacodynamics of the agent. Secondary endpoints aimed to document any changes in MS clinical status occurring during the 12-week dose confirmation phase of the study. These were determined through a variety of standard MS assessments including the MS Functional Composite (MSFC), Fatigue Severity Scale (FSS), Short Form Health Survey (SF-36) and Expanded Disability Status Scale (EDSS). Innate Immunotherapeutics expects to complete the Phase 1/2 study and announce final results in late 2012.

“We are very encouraged in the potential of MIS416 as a treatment for secondary progressive MS based on the results from this trial to date, as well as observations in a small number of patients who have received MIS416 under New Zealand compassionate use protocols,” said Simon Wilkinson, Innate Immunotherapeutics chief executive officer. “We intend to investigate the sustainability of the improvements in clinical status seen in this study through a 12 month Phase 2B study, which should begin enrollment in early 2013. We plan to conduct this study in Australia, to take advantage of that country's greater patient availability, the availability of excellent principal investigators and the financial support offered by the Australian government.”

“This increasingly coherent research around symptomatic relief, especially for those with secondary progressive forms of Multiple Sclerosis, is an exciting and extremely positive move in the right direction for those with MS and their families,” said Rosie Gallagher, National Director, Multiple Sclerosis Society of New Zealand. “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; 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 therefore 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.”

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

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 signaling 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

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 worsen, with or without occasional acute symptom flare-ups. There are no effective therapies currently approved for the ongoing treatment of secondary progressive MS.

About MS and the National Multiple Sclerosis Society

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. These problems may be permanent or may come and go. The National MS Society addresses the challenges of each person affected by MS by funding cutting-edge research, driving change through advocacy, facilitating professional education, collaborating with MS organizations around the world, and providing programs and services designed to help people with MS and their families move their lives forward. The Society is dedicated to achieving a world free of MS. Join the movement at http://www.nationalMSsociety.org.

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.innateimmuno.com.

 

Contact: Innate Immunotherapeutics
Simon Wilkinson, CEO, +64 21 661 850
simon@innateimmuno.com
http://www.innateimmuno.com
or
Kureczka/Martin Associates
Joan Kureczka, +1-415-821-2413 (Media)
Mobile: +1-415-690-0210
Joan@Kureczka-Martin.com

 

Posted: June 2012

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