Improvement of serum lipid panel by Tipelukast (MN-001)
in Type 2 Diabetes and NAFLD patients
Abstract # LI2022-1192
Kazuko MATSUDA, Malath MAKHAY, Yuichi IWAKI (MediciNova, Inc. La Jolla California USA)RESULTS (cont.)

INTRODUCTION
MN-001 (tipelukast) is a novel, orally bioavailable small
molecule with anti-inflammatory and anti-fibrotic activity
throughleukotriene
receptor
antagonism,
phosphodiesterase 3 and 4 inhibition, and 5lipoxygenase inhibition. In a recent clinical trial (MN001-NATG-201), MN-001 significantly reduced serum
triglycerides (TG) in patients with NAFLD andhypertriglyceridemia (HTG)1. Moreover, in vitro studies
demonstrated that MN-001 downregulates CD36 2,3and upregulates ABCG1 mRNA expression, both highly
associated with type 2 diabetes mellitus (T2DM).

AIMTo explore MN-001’s utility in indications other than
NAFLD, a sub-group analysis was conducted in thissample population dual-diagnosed with NAFLD andHTG, and presence of T2DM.

METHODOLOGY
MN-001-NATG-201 was an open-label study toevaluate MN-001’s effects on serum TG in subjects
who received MN-001 up to 500 mg/day for 12 weeks.
Subjects were grouped into 2 categories: with T2DM
and without T2DM. The changes in lipid profile, as well
as demographic and other baseline characteristics,
were assessed.

RESULTS
Subject
Mean Age (y)GenderMale/Female
Race
CaucasianPacific Islander
Mean Weight(kg)Mean TG (mg/dL)

All(n=19)
54.6

With T2DM(n=10)
56.7.

Without T2DM
(n=9)
52.2.

8 / 11

4/6

4/5

18
1

10
08
1

91.3

92.3

90.2

Baseline

Week 8ChangeAll Subjects (N=19)

345.7

206.9

-40.2 %

With T2DM (n=10)

444.7

218.7-50.8%

Without T2 DM (n=9)

235.7

193.8-17.8%

p-value

p=0.098

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Mean serum HDL(mg/dL)

Baseline Week 8

Changep-value

All Subjects (N=19)38.7

41.9+ 8.26 %With T2 DM (n=10)

36

41.7

+15.8 %

Without T2 DM (n=9)

41.8

42.2

+0.96 %

Mean serum LDL(mg/dL)

Baseline

Week 8ChangeAll Subjects (N=19)

118.1

104.4

-11.6 %

126.9

107.4

-15.4 %

108.3

101-6.7 %With T2 DM (n=10)
Without T2 DM (n=9)

p<0.0002

Compared to subjects without T2DM , the T2DM group
showed a trend in reduction of serum TG levels at Week
8 (50.82% versus 17.77%, p=0.098).
Mean HDL increase was significantly greater in subjects
with T2DM than subjects without T2DM at Week 8(15.83% versus 1.05%, p <0.0002).
In comparison to subjects without T2DM, the T2DM
group showed a trend in reduction in serum LDL levels
at Week 8 (15.37% versus 6.74%).

CONCLUSIONS
The magnitude of changes in serum TG and HDL were
substantially greater in the T2DM group than in the nonT2DM group in subjects with NAFLD/HTG comorbidity.
These findings suggest that MN-001 is a potential
treatment for patients with T2DM, NAFLD who havehypertriglyceridemia. Another trial has commenced toevaluate this phenomenon in patients with T2DM, NAFLD,and HTG (NCT 05464784).

REFERENCES
1. K Matsuda The International Liver Congress
2018, the 53rd annual meeting of the European
Association for the Study of the Liver (EASL)
2. M Ogura The Liver Meeting® 2021, the Annual
Meeting of the American Association for the Studyof Liver Diseases
3. M Ogura 19th International Symposium on
Atherosclerosis (ISA2021)

DISCLOSUREMean T. cholesterol(mg/dL)

Baseline

All Subjects (N=19)

202.9

187.7

-7.5 %

Matsuda K, Makhay M, and Iwaki Y are employeesof MediciNova, Inc.

With T2 DM (n=10)

210.2

192.8

-8.3 %CONTACT INFORMATION

Without T2 DM (n=9)

194.8

182

-6.6 %

Kazuko MATSUDA (Matsuda@medicinova.com)
Malath MAKHAY (Makhay@medicinova.com)

Week 8Change