Trius Therapeutics (TSRX) 8-K Statements made in this presentation regarding matters that are not historical facts are “forward-looking statements” within

1

Tedizolid 112 Trial: Top Line Results

Update

January 3, 2012

Exhibit 99.1

Best-in-Class Anti-Infectives

2

Forward Looking Statements

Statements made in this presentation 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, and

the results of the 112 study are not necessarily indicative of the results of the 113 study.  Such statements include, but are

not limited to, statements regarding Trius’ ability to successfully complete its ongoing clinical trials and development

programs and the expected timing for reporting of top-line data for the TR701-113 study.  Risks that contribute to the

uncertain nature of the forward-looking statements include: 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; the outcome of final analyses of data from recently-completed clinical trials of

tedizolid may vary from Trius’ initial analyses and the FDA may not agree with Trius’ interpretation of such results;

additional ongoing or planned clinical trials of tedizolid may produce negative or inconclusive results; Trius may decide, or

the FDA may require Trius, to conduct additional clinical trials or to modify Trius’ ongoing clinical trials; Trius may

experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or

significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result

in increased costs and delays, or limit Trius’ ability to obtain regulatory approval; the third parties with whom Trius has

partnered with for the development of tedizolid and upon whom Trius relies to conduct its clinical trials and manufacture its

product candidates may not perform as expected; tedizolid may not receive regulatory approval or be successfully

commercialized; unexpected adverse side effects or inadequate therapeutic efficacy of tedizolid could delay or prevent

regulatory approval or commercialization; Trius’ ability to obtain and maintain intellectual property protection for its product

candidates; the loss of key scientific or management personnel, Trius’ ability to obtain additional financing; and the

accuracy of Trius’ estimates regarding expenses, future revenues and capital requirements. These and other risks and

uncertainties are described more fully in Trius’ most recent 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

Progression of ABSSSI Regulatory Environment for Phase 3

Studies 112 and 113

May 2010:

First in a series of FDA requested meetings of the FNIH (Foundation for the

National Institutes of Health) working group established to provide recommendations to

the

FDA

on

endpoints

for

clinical

trials

of

drugs

for

ABSSSI

and

other

indications

June

2010:

FDA

grants

Trius

a

“SPA

Letter

of

Agreement”

for

study

#112

August 2010:

–

FDA issues “Draft ABSSSI guidance”

that reflect changes from the 112 SPA including:

•

Carry-over of early failures at secondary outcome measurement and exclusion of investigator-

reported pain at EOT as a secondary outcome failure criterion

August 2011:

–

FDA grants Trius an SPA agreement for study #113 that reflects the recent draft guidance

–

FNIH submits to the FDA its recommendations on ABSSSI guidance (ABSSSI Docket ID: FDA--2011--D-

-0433). The recommendations include:

•

Removal of fever as a component of the primary endpoint leaving cessation of spread &

reduction in lesion size as the sole parameters for the primary efficacy analysis at the 48-72hr

visit

•

Recommendation to also use  

20% reduction of lesion size at 48-72hrs as the primary

outcome

Trius has prospectively captured these suggested changes in the analyses of studies 112 and 113

Q2 2012: Expected issuance of final guidance on ABSSSI

4

Tedizolid Phosphate Phase 3 Study Design:

Oral (112) and IV/Oral (113) Trials Under SPA

Post Treatment

Post Treatment

Evaluations

Evaluations

Patient

Screening

Randomization

Safety Analyses

Safety Analyses

Baseline

EMA

Primary

Endpoint at

PTE

FDA Primary Endpoint

48-72 hrs from Baseline

EMA

Secondary

Endpoint

LFU

FDA

Secondary

Endpoints

at EOT

667

6-Days Tedizolid QD

4-Days Placebo

10-Days Linezolid BID

FDA

FDA

and

and

EMA

EMA

Endpoints

Endpoints

for

for

Global

Global

Registration

Registration

5

Study 112 Primary & Secondary Endpoints: Capturing

FDA and EMA Endpoints

Primary Endpoint*:

Cessation of lesion spread & resolution of fever at 48-72 hour visit after

initiation of study drug (ITT analysis set) [FDA Primary Endpoint]

Secondary Endpoints:

Sustained clinical response at EOT in the ITT analysis set (days

11-13)

Sustained clinical response at EOT in the CE-EOT analysis set (days 11-13)

Investigator’s

assessment of clinical success at PTE in the ITT analysis set

(days 17-24) [EMA Primary Endpoint]

Investigator’s

assessment of clinical success at PTE in the CE analysis set

(days 17-24)

*Study

112

was

90%

powered

for

a

10%

NI

margin

if

both

treatment

groups

had

~

81%

outcome

rate.

It

had 80% power for an outcome rate as low as 70%.

6

Primary Outcome at 48-72 hour visit

Treatment

Lesion Criteria

Fever Criteria

Tedizolid

(200 mg

QD 6 days)

Linezolid

(600 mg

BID 10 days)

No increase in lesion area from

baseline*

Temperature measurements

required within 24 hrs of

48-72 hr visit*

79.5%

79.4%

FNIH

recommended

to

FDA

to

exclude

temperature

as

a

component

of

the

primary

endpoint

and

to

assess

a

>20% reduction in lesion size at 48 to 72 hours.

Under these pre-specified analysis tedizold shows additional numerical separation from linezolid

No increase in lesion area from

baseline

Temperature excluded**

87.0%

85.4%

20% reduction of lesion area

from baseline**

Temperature excluded**

78.0%

76.1%

*   Primary endpoint as agreed to under Study 112 and 113 SPA

** FNIH

recommendations

to

FDA:

ABSSSI

Docket

ID:

FDA--2010--D--0433

Primary Outcome: All Current and Contemplated Trial 112

Primary Endpoints Achieved in Pre-Specified Analyses

7

Secondary Outcomes: Tedizolid Demonstrates Comparable

Efficacy with Shorter Course of Therapy

Secondary Outcome at EOT or PTE

Treatment

Secondary Outcome

Criteria

Tedizolid

(200 mg QD 6 days)

Linezolid

(600 mg BID 10 days)

Clinical Response at EOT*

(Day 11)

Early clinical failures carried

forward to EOT*

69.3% (ITT)

71.9% (ITT)

80.2% (CE)

81.1% (CE)

In August 2010 draft guidance the FDA adopted changes to the secondary outcomes of clinical

response at the end of therapy (EOT). These were prospectively measured in Study 112

sensitivity analyses and are captured in the Study 113 SPA.

Clinical Response at EOT*

(Day 11)

Early clinical failures not carried

forward to EOT**

80.7% (ITT)

80.9% (ITT)

87.5% (CE)

87.1% (CE)

Clinical Response at EOT*

(Day 11)

Early clinical failures not carried

forward to EOT** and

presence/absence of patient

reported pain at EOT excluded*/**

87.0% (ITT)

87.8% (ITT)

94.5% (CE)

95.1% (CE)

*   Primary and secondary endpoints as agreed to under Study 112 SPA

**   Consistent with FDA draft ABSSSI Guidance for Industry (August 2010)

8

EMA Endpoint: A Once-Daily 200mg Dose of Tedizolid for 6 Days

Demonstrates Comparable Efficacy to Twice-Daily 600mg Dose of

Linezolid for 10 Days of Treatment

Secondary Outcome at PTE

Treatment

Secondary Outcome

Criteria

Tedizolid

(200 mg QD 6 days)

Linezolid

(600 mg BID 10 days)

Clinical Response at PTE* (Day

17-24)

Clinician

assessment

at

PTE

85.5% (ITT)

86.0% (ITT)

94.6% (CE)

95.0% (CE)

*

EMA

primary

endpoint

(EMA

Report

on

the

workshop

on

Antibacterials

issued

March

2011).

Captured

in

both

the

Study

112

and

113

SPA

9

Shorter Course of Tedizolid Therapy Shows Comparable

Per Pathogen Clinical Response

Pathogen

Tedizolid

(200mg QD 6 days)

Linezolid

(600mg BID 10 days)

Staphylococcus

spp.

283/295 (96%)

300/302 (99%)

MRSA

73/78 (94%)

74/75 (99%)

MSSA

65/66 (99%)

75/75 (100%)

Other

7/7 (100%)

4/4 (100%)

Streptococcus

spp.

34/35 (97%)

27/29 (93%)

Clinical investigator’s assessment of clinical response at Post Treatment Evaluation (days 17-24)

in the Microbiological Evaluable analysis set

10

Tedizolid was Well Tolerated with a Favorable AE Profile

Compared to Linezolid

Adverse Event

Tedizolid

(200mg QD 6 days)

Linezolid

(600mg BID 10 days)

Any Treatment

Emergent Adverse

Event (TEAE)

40.8%

43.3%

Any Drug Related TEAE

24.2%

31.0%

Gastrointestinal

Disorders*

16.3%**

25.4%

*   Gastrointestinal AEs include: 

Diarrhea, Nausea, Vomiting and Dyspepsia 

** Statistically significant (p=0.004).

No Unexpected Safety Signals

•

Liver enzymes/function tests

•

QTc

Tedizolid had a numerically lower rate of drug-related treatment emergent adverse events (TEAE)

and

a

statistically

significant

lower

number

of

gastrointestinal

adverse

events

11

Hematology: Tedizolid had Significantly Lower Impact on

Platelets than Linezolid

Percent of Patients with Value below the

Lower Limit of Normal (LLN)

Hematology Parameter

Tedizolid

(200mg QD 6 days)

Linezolid

(600mg BID 10 days)

Platelets*

Below LLN

9.2%

14.9%

Platelets

-

Substantially

abnormal value

(<75% of LLN)

2.3%

4.9%

* Statistically significant (p=0.038)

12

Phase 3 trials conducted under new FDA ABSSSI guidance are

manageable

Study 112 design and outcomes will satisfy both FDA and EMA

regulatory requirements

All efficacy and safety objectives of Study 112 were successfully

achieved

–

Efficacy: All primary and secondary trial endpoints met with a once-daily short

course of therapy

–

Safety: statistically significant lower incidence in key tolerability and safety

parameters

Summary

13

Upcoming Milestones

Top line data from 112 Phase 3 ABSSSI trial

SPA for and initiation of Phase 3 pneumonia study

Potential partner for Europe

Initiation of clinical studies for Gyrase

Completion of enrollment for 113 Phase 3 ABSSSI trial