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#Post#: 1196--------------------------------------------------
Ibudilast receives fast track designation--studied for SPMS and
PPMS (MSAA Research News)
By: agate Date: April 28, 2016, 12:48 pm
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From the MSAA Research News, April 28, 2016:
[quote]Ibudilast Receives Fast Track Designation
In March, MediciNova, Inc., the biopharmaceutical company
developing ibudilast (MN-166), announced that this
investigational medication for progressive forms of MS has
received fast track designation from the United States Food and
Drug Administration (FDA). This designation makes the drug
eligible for a quicker review period, possibly leading to an
accelerated approval. It is intended for drugs under development
for treating serious diseases and with the potential to address
unmet medical needs for such diseases.
Once Phase III trial data are available for ibudilast, these may
be submitted to the FDA (along with its New Drug Application)
and the Fast Track designation would become effective.
Please note that the Phase II trial will not be completed until
the end of 2016, so Phase III data – needed to submit ibudilast
for approval – will not be available until a much later time.
Ibudilast is an oral agent with novel immune-modulating and
potential neuroprotective properties. It is being studied in
both secondary-progressive MS (SPMS) and primary-progressive MS
(PPMS).[/quote]
#Post#: 1544--------------------------------------------------
(Abst.) Randomized double-blind phase II clinical trial of ibudi
last in progressive MS
By: agate Date: January 29, 2017, 4:23 pm
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From PubMed:
[quote]Contemp Clin Trials. 2016 Sep;50:166-77.
Design, rationale, and baseline characteristics of the
randomized double-blind phase II clinical trial of ibudilast in
progressive multiple sclerosis
Fox RJ1, Coffey CS2, Cudkowicz ME3, Gleason T4, Goodman A5,
Klawiter EC6, Matsuda K7, McGovern M3, Conwit R8, Naismith R9,
Ashokkumar A2, Bermel R10, Ecklund D2, Koepp M2, Long J2,
Natarajan S10, Ramachandran S10, Skaramagas T10, Thornell B3,
Yankey J2, Agius M11, Bashir K12, Cohen B13, Coyle P14, Delgado
S15, Dewitt D16, Flores A17, Giesser B18, Goldman M19, Jubelt
B20, Lava N21, Lynch S22, Miravalle A23, Moses H24, Ontaneda
D10, Perumal J25, Racke M26, Repovic P27, Riley C28, Severson
C29, Shinnar S30, Suski V31, Weinstock-Gutman B32, Yadav V33,
Zabeti A34.
Author information
1Cleveland Clinic, Neurological Institute, Cleveland, OH, United
States. Electronic address: foxr@ccf.org.
2Data Coordinating Center, NeuroNEXT, University of Iowa, Iowa
City, IA, United States.
3Clinical Coordinating Center, NeuroNEXT, Harvard Partners,
Boston, MA, United States.
4Patient Advocate, Seattle, WA, United States.
5University of Rochester Medical Center, Rochester, NY, United
States.
6Massachusetts General Hospital, Boston, MA, United States.
7Medicinova Inc., La Jolla, CA, United States.
8National Institutes of Neurological Disease and Stroke,
Bethesda, MD, United States.
9Washington University School of Medicine, St. Louis, MO, United
States.
10Cleveland Clinic, Neurological Institute, Cleveland, OH,
United States.
11University of California at Davis, Sacramento, CA; currently
at Barrows Neurological Institute, Phoenix, AZ, United States.
12University of Alabama at Birmingham, Birmingham, AL, United
States.
13Northwestern University, Chicago, IL, United States.
14State University of New York, Stony Brook, NY, United States.
15University of Miami School of Medicine, Miami, FL, United
States.
16University of Utah, Salt Lake City, UT, United States.
17University of Texas Southwestern Medical Center, Dallas, TX,
United States.
18University of California at Los Angeles, Los Angeles, CA,
United States.
19University of Virginia at Charlottesville, Charlottesville,
VA, United States.
20State University of New York Upstate Medical University,
Syracuse, NY, United States.
21Emory University, Atlanta, GA, United States.
22University of Kansas Medical Center, Kansas City, KS, United
States.
23University of Colorado at Denver, Aurora, CO, United States.
24Vanderbilt University, Nashville, TN, United States.
25Weill Cornell Medical College, New York, NY, United States.
26The Ohio State University, Columbus, OH, United States.
27Swedish Medical Center at Seattle, Seattle, WA, United States.
28Columbia University Medical Center, New York, NY, United
States.
29Brigham and Women's Hospital, Brookline, MA, United States.
30Montefiore Medical Center, Bronx, NY, United States.
31University of Pittsburgh Medical Center, Pittsburgh, PA,
United States.
32State University of New York Buffalo, Buffalo, NY, United
States.
33Oregon Health and Science University, Portland, OR, United
States.
34University of Cincinnati, Cincinnati, OH, United States.
BACKGROUND:
Primary and secondary progressive multiple sclerosis (MS),
collectively called progressive multiple sclerosis (PMS), is
characterized by gradual progression of disability. The current
anti-inflammatory treatments for MS have little or no efficacy
in PMS in the absence of obvious active inflammation. Optimal
biomarkers for phase II PMS trials is unknown. Ibudilast is an
inhibitor of macrophage migration inhibitor factor and
phosphodiesterases-4 and -10 and exhibits possible
neuroprotective properties. The goals of SPRINT-MS study are to
evaluate the safety and efficacy of ibudilast in PMS and to
directly compare several imaging metrics for utility in PMS
trials.
METHODS:
SPRINT-MS is a randomized, placebo-controlled, phase II trial of
ibudilast in patients with PMS. Eligible subjects were
randomized 1:1 to receive either ibudilast (100mg/day) or
placebo for 96weeks. Imaging is conducted every 24weeks for
whole brain atrophy, magnetization transfer ratio, diffusion
tensor imaging, cortical brain atrophy, and retinal nerve fiber
layer thickness. Clinical outcomes include neurologic disability
and patient reported quality of life. Safety assessments include
laboratory testing, electrocardiography, and suicidality
screening.
RESULTS:
A total of 331 subjects were enrolled, of which 255 were
randomized onto active study treatment. Randomized subjects were
53.7% female and mean age 55.7 (SD 7.3) years. The last subject
is projected to complete the study in May 2017.
CONCLUSION:
SPRINT-MS is designed to evaluate the safety and efficacy of
ibudilast as a treatment for PMS while simultaneously validating
five different imaging biomarkers as outcome metrics for use in
future phase II proof-of-concept PMS trials.[/quote]
HTML https://www.ncbi.nlm.nih.gov/pubmed/27521810
HTML https://www.ncbi.nlm.nih.gov/pubmed/27521810
#Post#: 1866--------------------------------------------------
(ECTRIMS 2017) Ibudilast may offer benefit in progressive MS
By: agate Date: October 30, 2017, 8:07 pm
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From MedPage Today, October 30, 2017:
Anti-inflammatory drug may offer benefit in progressive MS
HTML https://www.medpagetoday.com/MeetingCoverage/ECTRIMS/68865?xid=nl_mpt_special_reports_2017-10-30%20&uun=g345846d0r5339616u
#Post#: 2060--------------------------------------------------
AAN2018: Ibudilast slows brain atrophy in trial
By: agate Date: April 25, 2018, 7:59 pm
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From Multiple Sclerosis News Today (April 19), a brief report on
a presentation at the AAN conference currently in session,
"#AAN2018: Potential MS therapy ibudilast slows brain atrophy in
trial":
HTML https://multiplesclerosisnewstoday.com/2018/04/19/aan2018-ibudilast-slows-brain-atrophy-progressive-multiple-sclerosis-phase-2-trial/?utm_source=Multiple+Sclerosis&utm_campaign=e3d7ca8aab-RSS_US_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_b5fb7a3dae-e3d7ca8aab-71286581
#Post#: 2200--------------------------------------------------
(Abst.) Phase 2 trial of ibudilast in progressive MS (NEJM)
By: agate Date: August 29, 2018, 6:32 pm
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This study, which involved both secondary and primary
progressive MS patients, was funded by a large number of major
organizations.
[quote][font=ff-quadraat-web-pro]Supported by grants from the
National Institute of Neurological Disorders and Stroke
([/font][font=ff-quadraat-web-pro]NINDS) (U01NS082329) and the
National Multiple Sclerosis Society (RG 4778-A-6) and by
MediciNova through a contract with the National Institutes of
Health (NIH). The NeuroNEXT Network is supported by the NINDS
(Central Coordinating Center, U01NS077179; Data Coordinating
Center, U01NS077352; and individual grants to each trial site).
Research reported in this article was also supported by grants
from the National Center for Advancing Translational Sciences of
the NIH to Case Western Reserve University (UL1 TR000439),
Columbia University Medical Center (UL1 TR 000040), Montefiore
Medical Center (UL1 TR002556), Oregon Health and Science
University (UL1TR0002369), University of Cincinnati (UL1
TR001425-03), University of Colorado Denver (KL2 TR001080),
Washington University in St. Louis (UL1 TR000448), and Weill
Cornell Medical Center (UL1 TR000457).[/font]
[/quote]
[font=verdana]The link below is to an abstract in the New
England Journal of Medicine (August 30, 2018):[/font]
[font=ff-quadraat-web-pro]
HTML https://www.nejm.org/doi/full/10.1056/NEJMoa1803583?query=TOC[/font]
#Post#: 2201--------------------------------------------------
Ibudilast explored for progressive MS in Phase 2 trial (MD magaz
ine)
By: agate Date: August 31, 2018, 12:59 am
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An article about it in MD (August 29, 2018)--"Ibudilast Explored
for Progressive MS in Phase 2 Trial":
[font=verdana]
HTML https://www.mdmag.com/medical-news/ibudilast-explored-for-progressive-multiple-sclerosis-in-phase-2-trial[/font]
#Post#: 2203--------------------------------------------------
More on ibudilast
By: agate Date: September 3, 2018, 12:54 am
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Ibudilast is getting considerable attention. From Medical News
Today, "MS: New drug proven to slow brain shrinkage" (August
30, 2018):
HTML https://www.medicalnewstoday.com/articles/322912.php?utm_source=newsletter&utm_medium=email&utm_country=US&utm_hcp=no&utm_campaign=MNT%20Daily%20Full%20%28non-HCP%20US%29%20-%20OLD%20STYLE%202018-08-30&utm_term=MNT%20Daily%20News%20%28non-HCP%20US%29
#Post#: 2512--------------------------------------------------
(AAN) Response to treatment according to progressive disease typ
e--Phase II ibudilast trial
By: agate Date: May 12, 2019, 3:55 pm
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Looks as if ibudilast showed more dramatic results in PPMS than
SPMS. Presented at the annual AAN conference (May 4-10, 2019),
"Response to Treatment According to Progressive Disease Type:
Analysis from a Phase II Progressive MS Trial of Ibudilast":
HTML http://indexsmart.mirasmart.com/AAN2019/PDFfiles/AAN2019-002237.pdf
#Post#: 2590--------------------------------------------------
Plans for Phase 3 trial of MN-166 (ibudilast) for SPMS without r
elapses
By: agate Date: July 19, 2019, 1:31 am
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This article may be drug-company hype but it does reveal that
ibudilast (MN-166) is going into a Phase 3 trial for use in SPMS
without relapses--the type of SPMS that hasn't been expected to
benefit from any of the MS drugs so far.
From the article:
[quote]We estimate the Phase 3 clinical trial for MN-166 in MS
will begin in 2020 and approval will be in 2024, with peak sales
of $5 billion approximately seven years after launch. [/quote]
MediciNova's plans for its Phase 3 trial of ibudilast for SPMS
are described in this article from Yahoo Finance (July 18,
2019):
HTML https://finance.yahoo.com/news/mnov-readying-phase-3-trial-200000909.html
#Post#: 4971--------------------------------------------------
(Abst.) Comprehensive systematic review of Ibudilast for progres
sive MS
By: agate Date: October 25, 2025, 6:55 pm
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From PubMed (October 25, 2025)--"A comprehensive systematic
review of Ibudilast as a neuroprotective therapy for progressive
multiple sclerosis":
HTML https://pubmed.ncbi.nlm.nih.gov/41135262/
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