Innate Immunotherapeutics Announces Clinical Trial Fully Enrolled And Receives Strong Interest From Potential Pharma Partners

Innate Immunotherapeutics Limited (ASX Code: IIL) 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 Innate Immunotherapeutics Limited (ASX Code: IIL) 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 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.

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