Innate Immunotherapeutics Limited has closed enrolment into the Company's Phase 2B placebo controlled efficacy trial of MIS416 in patients with secondary progressive multiple sclerosis (SPMS). The study has exceeded the original recruitment target of 90 subjects with the successful enrolment this week of the 93rd patient.
“SPMS is a devastating condition that currently has no effective treatment,” said Professor Peter Panegyres, one of the trial’s principal investigators in Perth, Australia. “We’re excited to be part of a trial that could see the development of a therapy that helps people living with SPMS manage their symptoms.”
Professor Panegyres said 75% of people with MS go on to develop SPMS, severely affecting their mobility, bodily functions and leading them to rely on others for their care.
Professor Pamela McCombe, a neurologist at Wesley Hospital in Brisbane, Australia, and a principal investigator in the trial, said patients had been enthusiastic to be part of the study.
“Drugs used in early stage MS aren’t effective in treating SPMS so finding a treatment for patients that slows the deterioration of their symptoms is very important,” she said.
The U.S.-based National MS Society's Executive Vice President for Research, Dr Bruce Bebo, said the Society was "very pleased to learn that Innate Immunotherapeutics has now fully recruited patients into the trial of MIS416 in people with SPMS. We look forward to learning the outcome of the trial as there are currently limited options available for treating this debilitating stage of MS." The Society played an early role in helping Innate Immunotherapeutics obtain funding for the trial through its commercial research arm, Fast Forward LLC.
As part of gaining ethical approval to conduct the current efficacy trial in Australia, the Company has undertaken to make MIS416 available to patients completing the 12-month study. To date nine of the 13 patients who have completed the study have requested support from their physicians to enable access to MIS416 post-study.
The study will be completed this time next year with a substantive initial report expected about four months later.
The Company also reports strong ongoing interest in the study from several major pharmaceutical companies (Pharma). These Pharma and the Company had multiple meetings prior to the commencement of the current Phase 2B trial in late 2014 with the study design benefitting as a result of these discussions. Subsequently Pharma have sought regular updates on the progress of the study as well as the ongoing scientific work into the novel mechanism of action of MIS416.
Innate's CEO Simon Wilkinson said: "I’m confident that a successful trial result in the first half of next year will quickly translate into a major partnering transaction."
About Innate Immunotherapeutics
Innate Immunotherapeutics Limited is an Australian biotechnology company with an exciting technology that targets the human innate immune system. The innate immune system is the body’s first line of defence against external disease causing pathogens such as bacteria and viruses, and internally caused diseases such as cancer. Disorders of the immune system can also cause or contribute to diseases such as multiple sclerosis. While the innate immune system is responsible for mounting the body’s initial defence against threats, it also plays a critical role in controlling the overall immune response and many for the body's tissue protective and reparative functions.
SPMS - The Significant Unmet Medical Need
Multiple sclerosis is a chronic disabling condition where the body’s immune system attacks the myelin sheath surrounding nerve fibres. The damaged myelin forms scar tissue which distorts or interrupts nerve impulses, disrupting the ability of parts of the nervous system to communicate properly. This can result in a wide range of symptoms, including loss of balance, muscle coordination, difficulty walking, slurred speech, tremors, stiffness, cognitive impairment, depression, fatigue and bladder problems.
Within 15 years of being diagnosed with the early 'relapsing-remitting' stage of MS, and despite the 12 drugs approved to treat this early stage of disease, about 60% of sufferers go on to develop a more advanced progressive form of disease - SPMS. After 20 years the number of SPMS sufferers increases to about 75%. There are currently no approved drugs for the effective ongoing treatment of SPMS. The Company's clinical development of MIS416 seeks to address this important unmet medical need and significant commercial opportunity.
About MIS416
The microparticle, MIS416, is a biologically derived novel immune modulator which can uniquely target both the regulatory and defensive functions of the innate immune system. MIS416 targets myeloid cells, a sub-set of innate immune cells not currently targeted by any other drugs in development for the treatment of SPMS.
Myeloid cells can play an important role inside the brain of a patient with SPMS by down regulating inflammation, helping clear myelin debris, and upregulating tissue repair processes.
Cycles of a diet that mimics fasting can reduce signs of immune system aging, as well as insulin resistance and liver fat