MediciNova Completes Enrollment in ALS MN-166 (Ibudilast) Phase 1/2 Trial
August 1, 2018 - als
The hearing (NCT02714036) has enrolled 35 ALS patients who will be treated with 100 mg daily doses (50 mg twice a day) of MN-166. The diagnosis is approaching to revoke a activation of a specific form of mind cells, a glial cells, that are pivotal players in some neurological diseases.
MN-166 is an verbal tiny proton able of stopping a movement of a proteins phosphodiesterase-4 and -10 and macrophage emigration inhibitory factor, heading to a termination of inflammation, activation of neurons’ duty and rebate of activated glial cells.
The devalue is being tested in other neurological disorders, including multiple sclerosis (MS), ALS and piece abuse/addiction. A before Phase 2 hearing (NCT02238626) showed a intensity of MN-166 to delay a course of ALS and improving survival of patients.
This ongoing multi-center, open-label Phase 1/2 examine will weigh MN-166 in patients with ALS, by tracking an ALS biomarker, a [11C]-PBR28.
The PBR28 protein is overproduced in activated glial cells and previous studies demonstrated it can be well tracked regulating atom glimmer tomography (PET) imaging and correlated to a course of a disease. Clinical outcomes of a patients also will be evaluated.
The 35 ALS patients enclosed in a examine contingency have been been diagnosed with ALS, possibly occasionally or familial, according to determined criteria. Also, they contingency not have taken Rilutek (riluzole) for during slightest 30 days, or be on a fast sip of a medicine for during slightest 30 days, before to screening.
Patients will be treated for 36 weeks. At a finish of this period, researchers will magnitude a outcome of MN-166 on shortening glial dungeon activation around [11C]-PBR28 uptake in specific tools of a brain, a engine cortices and mind stem.
As a primary goal, a group will examine a impact of MN-166 on several markers of neurological inflammation totalled by blood biomarkers.
Secondary goals of a examine engage reserve and tolerability profiles and clinical outcomes, including ALSFRS-R (ALS organic rating scale), flesh strength totalled by HHD (hand-held dynamometry) and SVC (slow critical capacity).
“We are really gratified that this examine is now entirely enrolled. We demeanour brazen to providing serve updates as we design to accept information from this examine subsequent year,” Yuichi Iwaki, PhD, boss and CEO of MediciNova, pronounced in a press release.
MN-166 is authorized for a diagnosis of post-stroke complications and bronchial asthma in Japan and Korea given 1989.
The examine is led by Nazem Atassi, MD, during Massachusetts General Hospital’s Neurological Clinical Research Institute and Harvard Medical School.