![]() 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% 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 |