Treating and Preventing Infectious Disease. November 2011 Nasdaq: INHX

Transcription

1 Treating and Preventing Infectious Disease November 2011 Nasdaq: INHX

2 Safe Harbor This presentation contains forward looking statements about Inhibitex and its business, business prospects, strategy and plans, including but not limited to statements regarding anticipated preclinical and clinical drug development activities and timelines and market opportunities. This presentation contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than historical facts included in this presentation are forward looking statements. These intentions, expectations, or results may not be achieved in the future and various important factors could cause actual results or events to differ materially from the forward looking statements that the Company makes, including cautionary statements contained in its Annual Report on Form 10 K for the year ended December 31, 2010, and in its Quarterly Report on Form 10 Q for the quarter ended November 8, Given these uncertainties, you should not place undue reliance on these forward lookingstatements, whichapplyonlyasofthedateofthispresentation. 2

3 Pipeline of Differentiated Anti Infective Products Preclinical Phase 1a Phase 1b Phase 2 Phase 3 INX-189 (Chronic HCV) 100 mg INX RBV Q RVR data from P2 GT 2/3 Q FV-100 (Shingles) Submit P2b protocol to FDA Q HCV Back- Up/Follow-On IND targeted for 2H 2012 Staph Infections SAg4 Phase 1/2 trial initiated Q

4 Chronic Hepatitis C Infections INX 189

5 Chronic HCV Unmet Needs Drive Significant Market Opportunity Despite the recent approval of the first direct acting antivirals (DAAs) for genotype 1 patients, improved safety, tolerability, and efficacy remain as unmet needs 8 10 million Chronic Patients in US, EU and Japan Oral DAA combinations that are generally safe, tolerable, efficacious and PegIFN free could dramatically expand the market to >$8B over the next decade <100K Cured 3 million Diagnosed <200K Treated 5

6 Objectives of HCV Therapies with Direct Acting Antivirals Improved overall cure rates (SVR) Improved safety and tolerability of treatment regimens Eliminate or shorten the duration of treatment with pegylated interferon Reduced treatment failures due to viral breakthrough & relapse Shorten overall duration of therapy 6

7 Evolution of HCV Therapy* The Old Days VRTX/MRK Duopoly New Kids on the Block Pre /2015 SOC = Peg IFN + RBV (48 weeks) 1st Gen PI (Incivek/Victrelis) + SOC (24 48 weeks) Nuc + RBV Nuc + DAA + RBV 2nd Gen PI + SOC (12, 24, or 48 weeks) IFN Still a Key Component of Treatment IFN free era Pros: Cons: Cure in 40% 50% pts Poor efficacy and tolerability Better efficacy and shorter tx Side effects from PIs, still need IFN, very complex treatment regimans Improved efficacy, tolerability, convenience Complexity of treatment choices, IFN still necessary 7 *Genotype 1 Source: Credit Suisse estimates; modified by INHX

8 INX 189 is Well Positioned as a Back Bone of Future HCV Therapies Well tolerated in Phase 1a/b (N=96) Highly synergistic with ribavirin O Potent pan genotypic antiviral activity N N High genetic barrier to resistance Low once daily dose amenable to fixed dose combinations O O O HN P O O HO O N OH N NH 2 Drug Drug interaction study with a DAA initiated INX 189 8

9 INX Phase 1b Multiple Ascending Dose Studies Dosing was once daily for 7 days 10 Subjects per Cohort, 8 Active and 2 Placebo 9 mg 25 mg 50 mg 100 mg 200 mg INX QD INX QD INX QD INX QD INX QD Placebo Placebo Placebo Placebo Placebo 9 mg INX QD + RBV 25 mg INX QD + RBV Placebo + RBV Placebo + RBV 100 mg INX QD + RBV Placebo + RBV 9

10 INX Exhibited Robust Antiviral Activity with Low, Once Daily Doses Median HCV RNA Change from Baseline (log 10 IU/mL) Treatment Period Day 7 Median Viral Load Declines log 10 IU/mL = 9 mg log 10 IU/mL = 25 mg log 10 IU/mL = 50 mg log 10 IU/mL = 100 mg log 10 IU/mL = 200 mg Placebo 9 mg INX-189 QD X 7 25 mg INX-189 QD X 7 50 mg INX-189 QD X mg INX-189 QD X mg INX-189 QD X 7 10

11 INX Exhibits Antiviral Synergy in Combination with Ribavirin (RBV) Median HCV RNA Change from Baseline (log 10 IU/mL) 1.0 Treatment Period log 10 IU/mL mg INX-189 monotherapy 9 mg INX RBV 25 mg INX-189 monotherapy 25 mg INX RBV RBV alone 11

12 Rapid Decline in ALT Enzyme Levels 25 Treatment Period 30 Treatment Period Mean Change in ALT (IU/mL) from Baseline Placebo 9 mg INX mg INX Mean Change in ALT (IU/mL) from Baseline Placebo + Ribavirin 9 mg INX mg INX Ribavirin mg/9mg INX mg INX mg INX mg INX Ribavirin mg INX mg INX

13 Safety Results Summary Generally well tolerated over 7 days of dosing No dose dependent trends in AE s One discontinuation due to AE; not study drug related No serious adverse events (SAE) reported in INX 189 dosed subjects 1 SAE in the placebo/rbv cohort (atrial fibrillation on 7 th day of dosing) No adverse events related to ECGs in INX 189 dosed subjects No grade 2 or greater Adverse Events related to clinical laboratory changes ALT decreases observed for all INX 189 dose cohorts No viral breakthrough 13

14 Phase 1b Extension in HCV GT1 Naïve Patients Median HCV RNA Day mg INX 189 QD Placebo 4.25 log IU/mL 100 mg INX 189 QD + RBV Placebo 100 mg INX 189 QD, food Placebo 100 mg INX 189 BID Placebo >200 mg INX 189 QD (TBD) Placebo 7 days dosing 8:2 randomization; INX 189:Placebo; RBV/placebo 14

15 Study INH : Phase 2 HCV Genotype 2/3 Study Design Week 4 ervr Y/N Week 12 Week 24 SVR Follow up SVR12 Week 36 N=25 25 mg INX 189 QD + Peg IFN/RBV Peg IFN/RBV N=25 50 mg INX 189 QD + Peg IFN/RBV Peg IFN/RBV N= mg INX 189 QD + Peg IFN/RBV Peg IFN/RBV N=15 Placebo + Peg IFN/RBV 15 Enrolling 90 HCV genotype 2/3 treatment naïve patients Stratified by IL28B status, baseline viral load, genotype Response Guided: INX 189 patients that achieve ervr will stop all therapy at 12 weeks Investigators, site staff, monitors and patients blinded to treatment assignment 50 subjects randomized Plan to add interferon free cohort(s)

16 Phase 2 HCV Genotype 1 Patients Interferon Free Regimens Goal To advance INX 189 into one or more 12 week studies in combination with another DAA in an interferon sparing treatment regimen Focus efforts on IFN free combinations for approvals in 2015 and beyond Preclinical evaluation of multiple DAA s in progress Initiated Phase 1 INX 189/DAA drug drug interaction study in healthy volunteers 16

17 HCV News Flow Over Next 9 Months Initiate Phase 2 GT 2/3 Study Phase 2 GT2/3 RVR data Phase 2 GT2/3 ervr data Phase 2 GT2/3 SVR12 data Phase 1b 7 day data Initiate IND enabling studies with new nuc Initiate Phase 1a/b trial of new nuc Q4 Q1 Q2 Q3 Initiate DDI with DAAs Initiate Phase 2 DDAs GT1 IFN free combo trial DAAs Combo RVR DAAs Combo ervr 17

18 Shingles FV 100

19 Shingles A Large and Rapidly Expanding, Underserved Market 19 Reactivation of varicella zoster virus (VZV) the chicken pox virus Most common neurological disease in the U.S. 50% of cases occur in individuals >60 years of age Number of herpes zoster cases are increasing substantially Estimated 10% CAGR in the number of cases over past decade Reducing shingles associated pain creates an opportunity to expand U.S. market opportunity to >$1B Commercial assessment supports significant pricing flexibility for a new compound that has an indication for the reduction of shinglesassociated pain and/or the prevention of post herpetic neuralgia (PHN) Pain indication eliminates potential price competition from generic antivirals

20 Unmet Clinical Need Reducing Shingles Associated Pain and PHN Rash Lesions Healed Day 1 Day 30 Day 90 Prodromal Acute Pain Sub Acute / Chronic Pain PHN Observed in >90% of patients Impacts 50% of patients 15 25% of patients will develop PHN 20

21 The Shingles Drug FV 100 A nucleoside analogue specifically designed to inhibit VZV replication Highly potent against VZV 10,000X more potent than valacyclovir Rapid onset of antiviral activity Highly lipophilic Well tolerated in clinical studies to date No dose related SAE s No dose adjustments required for patients with renal insufficiency FV 100 Once daily dosing 21

22 Phase 2a Clinical Trial Design Day 0 Day 7 Day 30 Day 60 Day 90 Burden of Illness Lesion Healing Burden of Illness PHN N= mg FV 100 QD N= mg FV 100 QD N= mg Valacyclovir Q8 Subjects 50 years of age with baseline Randomization <72 hrs after onset of rash 22

23 Phase 2a Top Line Results Pain Related Endpoints FV mg QD N=117 % Change from valacyclovir FV mg QD N=117 % Change from valacyclovir Valacyclovir 1000 mg Q8 N=116 BOI 30 AUC ± SE (6.24) 3% (6.08) 7% (6.25) BOI 90 AUC ± SE (19.51) 4% (19.01) 14% (19.55) day 90 (%) % % 20.2 Post hoc BOI14 90 AUC ±SE (18.0) 6% (17.6) 20% (18.1) BOI AUC ±SE (14.5) 1% 85.8 (14.2) 20% (14.6) 23 MITT2 population, LOCF analysis

24 Phase 2a Highlights FV 100 was well tolerated at both doses Dose dependent antiviral response observed 400 mg FV 100 arm consistently demonstrated better treatment differences than the 200 mg FV 100 arm Clinically meaningful reduction in incidence of PHN and time to resolution of clinically significant pain (CSP) observed with 400 mg FV 100 compared to valacyclovir 39% relative reduction in PHN (8% absolute reduction) Reduced median time to resolution of CSP from 21 to 15 days 24

25 Next Steps for FV 100 Submission of proposed Phase 2b protocol and Patient Recorded Outcomes (PRO) dossier to FDA Obtain additional regulatory feedback on a proposed Phase 2b protocol, endpoints and regulatory pathway that can support a pain related indication(s) for FV 100 Proposed Phase 2b trial Approximately 600 patients equally randomized to three treatment arms Primary endpoint : the time to resolution of clinically significant shingles pain Key secondary endpoint is the reduction in the incidence of PHN 25

26 Staphylococcal Vaccines Partnership with Pfizer for the development of staphylococcal vaccines 408 subject Phase 1 trial completed with a three antigen vaccine SAg3 (PF ) Demonstrated a favorable safety and immunogenicity profile 1068 subject Phase 1/2 trial initiated with SAg4, a multiple antigen vaccine containing clumping factor A (ClfA ) MSCRAMM protein Triggered clinical milestone payment from Pfizer 26

27 Key Financials (9/30/2011) Nasdaq Symbol INHX Commons Shares Outstanding (primary) 78.3M Cash and short term investments $53.7M 27

28 Key Milestones INX 189 Low dose, potent nucleotide analogue with established clinical proof of concept High genetic barrier to resistance Pan genotypic activity Once daily dosing FV 100 Potent nucleoside as potential SOC for the reduction of shingles associated pain & prevention of PHN Convenient once daily dosing >$1B potential market opportunity Milestones Complete Phase 1b trial end of Q Initiate Phase 2 GT 2/3 trial in Q Initiate Phase 1b monotherapy study using higher doses of INX 189 Q Initiate DDI studies with DAA(s) in Q Interim data (RVR) from Phase 2 GT 2/3 trial in Q Initiate DAA combination study(s) in GT1 naïve patients in Q Phase 2GT 2/3 EVR data in 1H 2012 Initiate IND enabling studies with second nucleotide inhibitor Milestones Complete analysis of FV 100 Phase 2 data in H Submit Phase 2b protocol and PRO dossier to FDA Q S. aureus Vaccine Milestones SAg4 vaccine containing ClfA antigen from the Inhibitex MSCRAMM protein platform Phase 1 immunogenicity data in 2011 Initiate additional S. aureus vaccine trial(s) in 2011

29 Treating and Preventing Infectious Disease November 2011 Nasdaq: INHX