Trius Therapeutics (TSRX) 8-K Trius Announces Positive Results from Establish 2 Study of

The Future of Anti-Infectives

ESTABLISH 2 Top Line Data Release

March 25, 2013

Exhibit 99.2

2

Forward Looking Statements

Statements

contained

in

this

data

release

regarding

matters

that

are

not

historical

facts

are

“forward-looking

statements”

within

the

meaning

of

the Private Securities Litigation Reform Act of 1995. Because such

statements are subject to risks and uncertainties, actual results may

differ materially from those expressed or implied by such forward-looking

statements.

Risks

that

contribute

to

the

uncertain

nature

of

the

forward-

looking

statements

include:

the

accuracy

of

Trius’

estimates

regarding

expenses, future revenues and capital requirements; the success and

timing of Trius’

preclinical studies and clinical trials; regulatory

developments

in

the

United

States

and

foreign

countries;

changes

in

Trius’

plans to develop and commercialize its product candidates; Trius’

ability

to

obtain

additional

financing;

Trius’

ability

to

obtain

and

maintain

intellectual

property

protection

for

its

product

candidates;

and

the

loss

of

key

scientific

or

management

personnel.

These

and

other

risks

and

uncertainties

are

described

more

fully

in

Trius’

most

recently

filed

SEC

documents, including its Form 10-K, Forms 10-Q and other documents

filed with the United States Securities and Exchange Commission,

including

those

factors

discussed

under

the

caption

“Risk

Factors”

in

such filings. All forward-looking statements contained in this press

release speak only as of the date on which they were made. Trius

undertakes no obligation to update such statements to reflect events that

occur or circumstances that exist after the date on which they were

made.

3

ESTABLISH 2 (IV/PO) Phase 3 Trial Design

2

o

EMA

1

o

EMA

Tedizolid

Linezolid

1x 200mg

2x 600mg

n=666

1

o

FDA

2

o

FDA

Placebo

Post-Treatment Evaluations

END-POINTS FOR GLOBAL REGISTRATION

Safety Analysis

Non-inferiority trial design vs. Linezolid

4

ESTABLISH 2 Primary & Secondary Endpoints

Primary Endpoint:

•

20% or greater reduction in lesion area at 48-72 hours after first dose of drug

Secondary Endpoints:

•

Programmatic clinical response at end of therapy (EOT)

•

Investigator’s

assessment of clinical response at post treatment evaluation (PTE)

5

ESTABLISH 2 Demographics and Baseline Characteristics

Tedizolid, %

n = 332

Linezolid, %

n = 334

Male, %

67.8

64.1

Age, mean

45.6

45.6

Geographic Region, %

North America (US)

47.0

47.3

Ex-U.S.

53.0

52.7

Clinical Syndrome, %

Cellulitis/erysipelas

50.0

50.3

Major abscess

20.5

20.4

Wound infection

29.5

29.3

MRSA (MITT), %

27.2

26.9

MSSA (MITT), %

52.8

53.0

Lymphadenopathy, %

70.8

70.4

WBC < 4,000 or > 10,000, %

53.0

45.2

Immature neutrophils, %

16.2

12.2

Fever, %

31.0

29.0

6

ESTABLISH 2 Efficacy

ITT Analysis Set

Endpoint

Tedizolid

6 days

treatment, %

n = 332

Linezolid

10 days

treatment, %

n = 334

Treatment

Difference

(95% CI), %

Primary Endpoint

>20% decrease from

baseline in lesion

area at 48-72 hours

85.2

82.6

2.6 (-3.0 to 8.2)

Key Secondary

Endpoints

Sustained clinical

response at end of

therapy

87.0

88.0

-1.0 (-6.1 to 4.1)

Investigators

assessment of

clinical response at

7-14 days after end

of therapy

88.0

87.7

0.3 (-4.8 to 5.3)

Sensitivity

analysis

(2010 FDA

Guidance)

Cessation of lesion

spread and absence

of fever at 48-72

hours

85.8

81.4

4.4 (-1.2 to 10.1)

7

ESTABLISH 2 Efficacy by Infection Type

ITT Analysis Set

Tedizolid

6 days

treatment, %

n = 332

Linezolid

10 days

treatment, %

n = 334

Treatment

Difference

(95% CI), %

Cellulitis/erysipelas

80.7

n = 166

80.4

n = 168

0.37 (-8.2 to 8.9)

Major cutaneous

abscess

86.8

n = 68

89.7

n = 68

-2.9 (-14.5 to 8.4)

Wound infection

91.8

n = 98

81.6

n = 98

10.2 (0.71 to 20.1)

8

ESTABLISH 2 Safety: Tedizolid was Safe and Well

Tolerated with a Favorable AE Profile vs. Linezolid

Safety Analysis Set

Tedizolid

6 days treatment, %

Linezolid

10 days treatment, %

Any Treatment Emergent

Adverse Event (TEAE)

45.3

43.7

Any Drug Related TEAE

20.5

24.8

Gastrointestinal Disorders

16.0

20.5

No Safety Signals

9

ESTABLISH 2 Incidence of TEAEs >2%

System Organ Class

Tedizolid, (%)

n = 331

Linezolid, (%)

n =327

Gastrointestinal disorders

53 (16.0)

67 (20.5)

General disorders and

administration site conditions

23 (6.9)

24 (7.3)

Infections and infestations

40 (12.1)

40 (12.2)

Metabolism and nutrition

disorders

9 (2.7)

7 (2.1)

Musculoskeletal and connective

tissue disorders

9 (2.7)

9 (2.8)

Nervous system disorders

29 (8.8)

36 (11.0)

Psychiatric disorders

10 (3.0)

4 (1.2)

Respiratory, thoracic and

mediastinal disorders

6 (1.8)

13 (4.0)

Skin and subcutaneous tissue

disorders

21 (6.3)

24 (7.3)

Vascular disorders

7 (2.1)

4 (1.2)

10

ESTABLISH 2 Post-Baseline Substantially Abnormal

Hematology Values

Tedizolid, (%)

n = 331

Linezolid, (%)

n =327

Hemoglobin

292

287

Below LLN

147 (50.3)

148 (51.6)

Substantially abnormal

4 (1.4)

2 (0.7)

White blood cells

272

258

Below LLN

16 (5.9)

20 (7.8)

Substantially abnormal

3 (1.1)

5 (1.9)

Platelets

275

269

Below LLN

37 (13.5)

35 (13.0)

Substantially abnormal

9 (3.3)

5 (1.9)

11

Differences Between ESTABLISH 1 and 2

ESTABLISH 2

ESTABLISH 1

Dosing

IV to oral

(minimum

1

st

day’s

dosing

IV)

Oral

Demographics

US 47%, x-US 53%

US 80%, x-US 20%

MRSA, %

27.1

42.6

Primary

Endpoint*

>

20% reduction in lesion

area @ 48 to 72 hours

Cessation of lesion spread,

absence of fever @ 48 to 72 hours

*ESTABLISH 2 SPA amended under agreement with FDA to reflect expected new primary endpoint. Both endpoints

prospectively captured as sensitivity analyses in respective studies. Integrated summary of efficacy will reflect the

ESTABLISH 2 primary endpoint under the amended SPAs

12

ESTABLISH Program Comparison

Endpoint

Study

Tedizolid

6 days

treatment, %

Linezolid

10 days

treatment, %

Treatment

Difference

(95% CI), %

>20% decrease from

baseline in lesion area at

48-72 hours

ESTABLISH 2

ESTABLISH 1

85.2

78.0

82.6

76.1

2.6 (-3.0 to 8.2)

1.9 (-4.5 to 8.3)

Sustained clinical

response at end of

therapy

ESTABLISH 2

ESTABLISH 1

87.0

87.0

88.0

87.8

-1.0 (-6.1 to 4.1)

-0.8 (-5.8 to 4.4)

Investigators assessment

of clinical response at 7-

14 days after end of

therapy

ESTABLISH 2

ESTABLISH 1

88.0

85.5

87.7

86.0

0.3 (-4.8 to 5.3)

-0.5 (-5.8 to 4.9)

Cessation of lesion

spread and absence of

fever at 48-72 hours

ESTABLISH 2

ESTABLISH 1

85.8

79.5

81.4

79.4

4.4 (-1.2 to 10.1)

0.1 (-6.1 to 6.2)

13

ESTABLISH Program Safety Comparison

Safety Analysis Set

Study

Tedizolid %

Linezolid %

Any Treatment

Emergent Adverse

Event (TEAE)

ESTABLISH 2

45.3

43.7

ESTABLISH 1

40.8

43.3

Any Drug Related

TEAE

ESTABLISH 2

20.5

24.8

ESTABLISH 1

24.2

31.0

Gastrointestinal

Disorders

ESTABLISH 2

16.0

20.5

ESTABLISH 1

16.3

25.4

14

Summary

•

All primary and secondary efficacy endpoints were met for FDA and EMA

•

Safety profile indicated that tedizolid was safe and well tolerated

•

Results are consistent with those from ESTABLISH 1 and support filings for

global regulatory approval

•

Combined results of all clinical studies support tedizolid differentiation:

–

Safe, well tolerated, fast acting drug for resistant gram positive infections

–

Convenient once daily IV or oral administration over short course of therapy

–

Fewer drug-drug interactions

–

Active against key linezolid resistant strains

15

*Efficacy performance ratings among those aware of brand

Tedizolid

ATU

Study,

Wave

1

–

USA

Report,

conducted

by

CMI

on

behalf

of

Trius,

November

2012,

N=505

Strong Response to Tedizolid Efficacy, Dosing and

Administration

*

Tedizolid, 65%

Tedizolid, 52%

Zyvox, 62%

Zyvox, 42%

Cubicin, 54%

Cubicin, 37%

Vancomycin, 25%

Vancomycin, 27%

Tedizolid, 45%

Tedizolid, 42%

Zyvox, 45%

Zyvox, 38%

Cubicin, 42%

Cubicin, 37%

Vancomycin, 30%

Vancomycin, 30%

Offers simple dosing and

administration

Has a lower potential for

resistance development 

Has superior efficacy vs.

other products 

Is effective for all patient

types

16

Strong Response to Tedizolid Safety & Tolerability

Has a low frequency of

DDI (drug-drug

interaction)

Does not cause renal

and hepatic impairment

Has a low frequency of

safety/adverse events

*Efficacy performance ratings among those aware of brand

Tedizolid

ATU

Study,

Wave

1

–

USA

Report,

conducted

by

CMI

on

behalf

of

Trius,

November

2012,

N=505

Tedizolid, 48%

Tedizolid, 53%

Tedizolid, 59%

Zyvox, 27%

Zyvox, 45%

Zyvox, 31%

Cubicin, 48%

Cubicin, 42%

Cubicin, 44%

Vancomycin, 39%

Vanco

., 14%

Vancomycin, 25%

17

Tedizolid

ATU

Study,

Wave

1

–

USA

Report,

conducted

by

CMI

on

behalf

of

Trius,

November

2012,

N=505

Base: Total respondents

Q8.1

How

interesting

is

tedizolid

to

you

for

suspected

or

confirmed

MRSA

ABSSSI

patients

overall?

Use

a

1

to

10

scale

where

“1”

means

“Not

at

all

Interesting”

and

“10”

means

“Very

Interesting,”

to

indicate

your

level

of

interest.

Interest in Tedizolid, by Specialty

(0 = Not Interested, 10 = Very Interested)

Physician Interest in Tedizolid Strong Across Specialties

Total

(N = 505)

Critical Care,

Pulmonologist

(n = 120)

Internist

(n = 137)

General

Surgeon

(n = 86)

Hospitalist

(n = 175)

Infectious

Disease

Specialist

(n = 101)

Infusion Clinic

Specialist

(n = 75)

80%

69%

74%

72%

76%

92%

83%

19%

31%

25%

27%

23%

7%

17%

High Interest (8-10)

Neutral (4-7)

Low Interest (1-3)

18

Upcoming Milestones

•

Late breaker presentations at ECCMID conference (submitted for

April)

•

Detailed data presentations at ICAAC conference (September)

•

Advance EU partnership discussions

•

NDA Filing (H2 2013)

•

Implement pre-commercial activities for potential U.S. launch (H2 2013)

•

Initiation of Phase 3 ventilated nosocomial pneumonia study (H2 2013)

•

EMA Filing (H1 2014)

•

Potential PDUFA date for ABSSSI (mid 2014)