Median (Min Max) CVC 100 mg + EFV placebo + TDF/FTC (N=8) CVC 200 mg + EFV placebo + TDF/FTC (N=10) LLOQ=5.00 ng/ml Time (h)

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1 600 Pharmacokinetics (Pk) of cenicriviroc (cvc) following 100 or 200 mg once-daily Dosing with open-label tenofovir / emtricitabine (tdf/ftc) in hiv-1 infected subjects enrolled in a Phase 2b study David Martin 1, Martin Beliveau 2, JF Marier 2, Reynold Driz 1, Sandra Palleja 1 1 Tobira Therapeutics, Inc., South San Francisco, CA, USA; 2 Pharsight, a Certara Company, Montreal, Quebec, Canada Eric Lefebvre, MD Chief Medical Officer Tobira Therapeutics, Inc. 400 Oyster Point Boulevard, Suite 525 South San Francisco, CA (650) elefebvre@tobiratherapeutics.com background results conclusions CVC is a potent, once-daily (QD) oral CCR5/CCR2 receptor antagonist undergoing clinical investigation for treatment of HIV-1 infection. Study 202 (Study ; NCT ) is an ongoing, randomized, doubleblind Phase 2b study to evaluate the efficacy and safety of 100 and 200 mg QD doses of CVC versus QD efavirenz (EFV), each with open-label TDF/FTC in treatmentnaïve HIV-1 infected subjects. The current 50-mg tablet formulation was used for this study and a planned interim analysis of CVC in the first 25 enrolled subjects was performed to evaluate the steady-state PK of this new formulation. The exposure-effect relationship methodology Pharmacokinetic Study Design Study 202 is a randomized, double-blind, doubledummy, 48-week comparative study in approximately 150 HIV-1 infected, treatment-naïve subjects with only CCR5-tropic virus. Truvada (TDF/FTC) is provided open label. Subjects are stratified by screening HIV-1 RNA level ( 100,000 copies/ml versus <100,000 copies/ml) and randomized 2:2:1 to receive the following treatments orally: Arm A: (2 50 mg tablets) QD + CVC matching placebo (2 tablets) QD with food + EFV matching placebo (1 capsule) QHS (1 tablet containing 300 mg TDF and 200 mg FTC) QD Arm B: (4 50 mg tablets) QD with food + EFV matching placebo (1 capsule) QHS Arm C: CVC matching placebo (4 tablets) QD with food + EFV 600 mg (1 capsule) QHS The first 25 subjects enrolled in the study took CVC or matched placebo in the morning following a low-fat breakfast. They underwent a full 24-hour, intensive PK sampling on Day 14 with samples collected at predose (time 0), and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 h postdose (the hour 24 sample was collected immediately predose on Day 15). The subjects continued treatment while the PK of CVC was assessed. Trough samples were also collected on Day 28 per protocol. The PK analysis was conducted by an unblinded, independent biometrics group while the sponsor, investigators, and subjects remained blinded. Given the ongoing status and blinded nature of the study, efficacy and safety data are not reported. Target CVC Concentrations The target Cavg was estimated using the CVC plasma concentration profiles observed in study The fasted distribution of clearances (ie, minimum and maximum values observed by noncompartmental analysis) at the 100 and 200 mg dose levels and the distribution of clearances obtained following for CVC had been previously established in a 10-day monotherapy study with an estimated Emax of 1.43 log10 copies/ml and an IC50 of 13.1 ng/ml. 1 Based on adequate plasma CVC exposure (predicted average plasma CVC concentration [Cavg] 55.6 to 722 ng/ml) in the first 25 subjects enrolled expected to provide a Cavg of at least 55 ng/ml or ~80% of the estimated Emax. 2 Based on adequate plasma CVC exposure (55.6 to 722 ng/ml) in the first 25 subjects enrolled in the PK substudy (20 randomized to CVC), the remaining 125 subjects will be enrolled as planned in the study protocol. administration of 50 mg under fed conditions were adjusted to account for administration of 100 mg and 200 mg of CVC by using the reconstructed fed distribution of clearances. This modeling exercise was performed to predict the range of CVC exposure according to different dose levels (50, 100, or 200 mg QD) and fasted/fed conditions. The pharmacokinetics/pharmacodynamics (PK/PD) of CVC were estimated using a simple model correlating the Cavg of CVC (ng/ml) and change in (Δ) HIV-1 RNA (log10 copies/ml) derived from a monotherapy study conducted in HIV-1 infected patients, as previously published. 1 Cavg Effect (ΔlogHIV-1 RNA) = Emax (IC50 + Cavg) h The Emax and IC50 values of CVC were 1.43 log10 copies/ml and 13.1 ng/ml, respectively. Based on these calculations, a dose level of 100 mg QD under fed conditions was expected to result in a range of exposure (Cavg 55.6 to 275 ng/ml) that is associated with an estimated viral suppression range that is considered acceptable (81% to 95% of maximal suppression). 2 A dose level of 200 mg QD under fed conditions was expected to result in a range of exposure (Cavg 146 to n g /m L ) t h a t i s a s s o c i a t e d w i t h a n e s t i m a t e d v i r a l s u p - pression range of 92% to 98% of maximal suppression. Noncompartmental Analysis of CVC in Subjects Noncompartmental analysis was performed to assess steady-state plasma CVC PK parameters. The area under the concentration-time curve (AUC0-t), Cavg, maximum concentration (Cmax), minimum concentration (Cmin), and time to maximum concentrations (Tmax) of CVC were derived. The half-life (t1/2) was determined based on log-linear regression of the apparent terminal phase of the profile. CVC Plasma Concentrations and PK Parameters A total of 25 subjects were randomized into this PK substudy (Table 1). Table 1. Summary PK Population Demographics at Randomization Subject Data Count Number of Patients 25 Males/Females 24/1 Race (White/African American/Other) 15/8/2 Median (Min Max) Age (years) 39.1 ( ) Baseline HIV-1 RNA (log10 copies/ml) 4.41 ( ) Baseline CD4 Count (/mm 3 ) 354 ( ) There were a total of four early withdrawals with three occurring prior to Study Day 14 PK collection and one after Day 14; two subjects were withdrawn because of protocol noncompliance and two subjects were withdrawn for tolerability reasons. Day 14 PK data were available for a total of 18 CVC-treated subjects. At the time of the last Day 14 sample analysis, Day 28 trough concentrations were available for a total of seven CVC-treated subjects. Mean (SE) CVC plasma concentration-time profiles are presented in Figure 1. Profiles displayed roughly bi-exponential decline and were quantifiable across the sampling times. Figure 1. Mean (SE) CVC Concentration-Time Profiles Mean (SE) Plasma CVC Concentration (ng/ml) Time (h) (N=8) (N=10) LLOQ=5.00 ng/ml Mean PK parameters are presented in Table 2. C avg geometric mean (CV%) values of CVC for the 100 and 200 mg doses were 86.6 (46.2%) and 210 (56.0%) ng/ml, respectively. Mean (CV%) Cmin values for the 100 and 200 mg doses were 41.0 (64.8%) and 89.2 (59.3%) ng/ml, respectively. Median Tmax for the 100 and 200 mg doses were observed at 5.00 and 6.00 h, respectively. Overall, CVC was well absorbed following repeat dosing of 100 and 200 mg QD, and exposure increased in a dose-proportional manner. Mean Cavg values of CVC for the 100 and 200 mg dose corresponded ~88% and 95%, respectively, of the estimated Cavg needed to achieve Emax. Table 2. Summary Noncompartmental Plasma CVC PK Parameters in Evaluable Subjects Treatment Variable N Geometric Mean Geometric CV% Min Max * Median provided for Tmax AU C 0-t (h*ng/ml) Cavg (ng/ml) Cmax (ng/ml) Cmin (ng/ml) t1/2 (h) Tmax (h) * AU C 0-t (h*ng/ml) Cavg (ng/ml) Cmax (ng/ml) Cmin (ng/ml) t1/2 (h) Tmax (h) * The plasma CVC Cavg for one subject (blinded Subject Number 107), randomized to the dose group, was lower than the target range (ie, 55.6 to 722 ng/ml) on Day 14 with a concentration of 44.1 ng/ml. This incongruous data point was investigated and no obvious clinical reason (adherence, schedule of dose, food intake) was identified. To evaluate this subject further, this subject s trough samples (ie, predose) on Days 14 and 15 were compared to the trough concentration on Day 28 from the six other patients with available data at the time of the sample analysis. Geometric mean trough concentrations for all evaluable subjects on Days 14 and 28 are provided in Table 3. Predose concentrations on Day 14 and 15 for Subject 107 (18.6 and 15.9 ng/ml, respectively) appeared to be low relative to their corresponding group geometric mean. The trough concentration for Subject 107 on Day 28 (51.0 ng/ml) was consistent with the mean value of the group (59.5 ng/ml), suggesting that the unexpectedly low exposure to CVC on Day 14 for Subject 107 was transitory in nature. Trough concentrations were consistent between predose on Days 14 and 28, suggesting that steady state was achieved by Day 14 (Table 3). Table 3. Summary of Trough Plasma CVC Concentrations on Days 14 and 28 in Evaluable Subjects Treatment Predose N Geometric Mean (ng/ml) Geometric CV% Day Day Day Day Day Day A planned interim PK analysis on plasma CVC concentrations following once-daily administration of CVC to HIV-1 infected subjects in ongoing Study 202 was performed. Summary results are presented below. Cavg ranged from 44.1 to 159 ng/ml at the 100 mg CVC dose level and from 75.4 to 373 ng/ml at the 200 mg CVC dose level. Cmax was observed at 5 6 hours postdose for the low and high dose levels. Geometric mean values of Cmax for the 100 and 200 mg dose levels on Day 14 were 158 and 364 ng/ml, respectively. Plasma exposure to CVC appears to increase in a dose-proportional manner. Geometric mean Cavg values of CVC for the 100 and 200 mg dose corresponded to ~88% and 95%, respectively, of the estimated Cavg needed to achieve Emax, suggesting that adequate exposure for virologic suppression was achieved for both dose levels. Study 202 is ongoing and will evaluate the efficacy and safety of CVC in treatment-naïve HIV-1 infected subjects. references 1. Marier JF, Trinh M, Pheng LH, Palleja SM, Martin DE. Pharmacokinetics and pharmacodynamics of TBR-652, a novel CCR5 antagonist, in HIV-1 infected, antiretroviral treatment-experienced, CCR5 antagonist-naive patients. Antimicrob Agents Chemother. 2011;55(6): Clinical Study Report : A Phase I, Fixed- Sequence, 4-Period, Cross-Over Pharmacokinetic Study of Two Test Formulations of TBR-652 in Fasted and Fed Healthy Volunteers. 15 June acknowledgements We would like to thank the Study investigators, site personnel and study subjects who are participating in this clinical trial and Charles Ballow, PharmD and the staff at Buffalo Clinical Research Center for their work on Study We also thank Sally Snyder and Rob Grosso for their assistance with preparation of this poster. The 19th Conference on Retroviruses and Opportunistic Infections March 5 8, 2012 Seattle, Washington

2 background CVC is a potent, once-daily (QD) oral CCR5/CCR2 receptor antagonist undergoing clinical investigation for treatment of HIV-1 infection. Study 202 (Study ; NCT ) is an ongoing, randomized, doubleblind Phase 2b study to evaluate the efficacy and safety of 100 and 200 mg QD doses of CVC versus QD efavirenz (EFV), each with open-label TDF/FTC in treatmentnaïve HIV-1 infected subjects. The current 50-mg tablet formulation was used for this study and a planned interim analysis of CVC in the first 25 enrolled subjects was performed to evaluate the steady-state PK of this new formulation. The exposure-effect relationship for CVC had been previously established in a 10-day monotherapy study with an estimated E max of 1.43 log 10 copies/ml and an IC 50 of 13.1 ng/ml. 1 Based on adequate plasma CVC exposure (predicted average plasma CVC concentration [C avg ] 55.6 to 722 ng/ml) in the first 25 subjects enrolled expected to provide a C avg of at least 55 ng/ml or ~80% of the estimated E max. 2 Based on adequate plasma CVC exposure (55.6 to 722 ng/ml) in the first 25 subjects enrolled in the PK substudy (20 randomized to CVC), the remaining 125 subjects will be enrolled as planned in the study protocol. methodology Pharmacokinetic Study Design Study 202 is a randomized, double-blind, doubledummy, 48-week comparative study in approximately 150 HIV-1 infected, treatment-naïve subjects with only CCR5-tropic virus. Truvada (TDF/FTC) is provided open label. Subjects are stratified by screening HIV-1 RNA level ( 100,000 copies/ml versus <100,000 copies/ml) and randomized 2:2:1 to receive the following treatments orally: Arm A: (2 50 mg tablets) QD + CVC matching placebo (2 tablets) QD with food + EFV matching placebo (1 capsule) QHS (1 tablet containing 300 mg TDF and 200 mg FTC) QD Arm B: (4 50 mg tablets) QD with food + EFV matching placebo (1 capsule) QHS Arm C: CVC matching placebo (4 tablets) QD with food + EFV 600 mg (1 capsule) QHS The first 25 subjects enrolled in the study took CVC or matched placebo in the morning following a low-fat breakfast. They underwent a full 24-hour, intensive PK sampling on Day 14 with samples collected at predose (time 0), and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 h postdose (the hour 24 sample was collected immediately predose on Day 15). The subjects continued treatment while the PK of CVC was assessed. Trough samples were also collected on Day 28 per protocol. The PK analysis was conducted by an unblinded, independent biometrics group while the sponsor, investigators, and subjects remained blinded. Given the ongoing status and blinded nature of the study, efficacy and safety data are not reported. Target CVC Concentrations The target C avg was estimated using the CVC plasma concentration profiles observed in study The fasted distribution of clearances (ie, minimum and maximum values observed by noncompartmental analysis) at the 100 and 200 mg dose levels and the distribution of clearances obtained following administration of 50 mg under fed conditions were adjusted to account for administration of 100 mg and 200 mg of CVC by using the reconstructed fed distribution of clearances. This modeling exercise was performed to predict the range of CVC exposure according to different dose levels (50, 100, or 200 mg QD) and fasted/fed conditions. The pharmacokinetics/pharmacodynamics (PK/PD) of CVC were estimated using a simple model correlating the C avg of CVC (ng/ml) and change in (Δ) HIV-1 RNA (log 10 copies/ml) derived from a monotherapy study conducted in HIV-1 infected patients, as previously published. 1 C avg Effect (ΔlogHIV-1 RNA) = E max (IC 50 + C avg ) h The E max and IC 50 values of CVC were 1.43 log 10 copies/ml and 13.1 ng/ml, respectively. Based on these calculations, a dose level of 100 mg QD under fed conditions was expected to result in a range of exposure (C avg 55.6 to 275 ng/ml) that is associated with an estimated viral suppression range that is considered acceptable (81% to 95% of maximal suppression). 2 A dose level of 200 mg QD under fed conditions was expected to result in a range of exposure (C avg 146 to 722 ng/ml) that is associated with an estimated viral suppression range of 92% to 98% of maximal suppression. Noncompartmental Analysis of CVC in Subjects Noncompartmental analysis was performed to assess steady-state plasma CVC PK parameters. The area under the concentration-time curve (AUC 0-t ), C avg, maximum concentration (C max ), minimum concentration (C min ), and time to maximum concentrations (T max ) of CVC were derived. The half-life (t 1/2 ) was determined based on log-linear regression of the apparent terminal phase of the profile.

3 results CVC Plasma Concentrations and PK Parameters A total of 25 subjects were randomized into this PK substudy (Table 1). Table 1. Summary PK Population Demographics at Randomization Subject Data Count Number of Patients 25 Males/Females 24/1 Race (White/African American/Other) 15/8/2 Median (Min Max) Age (years) 39.1 ( ) Baseline HIV-1 RNA (log 10 copies/ml) 4.41 ( ) Baseline CD4 Count (/mm 3 ) 354 ( ) There were a total of four early withdrawals with three occurring prior to Study Day 14 PK collection and one after Day 14; two subjects were withdrawn because of protocol noncompliance and two subjects were withdrawn for tolerability reasons. Day 14 PK data were available for a total of 18 CVC-treated subjects. At the time of the last Day 14 sample analysis, Day 28 trough concentrations were available for a total of seven CVC-treated subjects. Mean (SE) CVC plasma concentration-time profiles are presented in Figure 1. Profiles displayed roughly bi-exponential decline and were quantifiable across the sampling times. Figure 1. Mean (SE) CVC Concentration-Time Profiles Mean (SE) Plasma CVC Concentration (ng/ml) Time (h) (N=8) (N=10) LLOQ=5.00 ng/ml Mean PK parameters are presented in Table 2. C avg geometric mean (CV%) values of CVC for the 100 and 200 mg doses were 86.6 (46.2%) and 210 (56.0%) ng/ml, respectively. Mean (CV%) C min values for the 100 and 200 mg doses were 41.0 (64.8%) and 89.2 (59.3%) ng/ml, respectively. Median T max for the 100 and 200 mg doses were observed at 5.00 and 6.00 h, respectively. Overall, CVC was well absorbed following repeat dosing of 100 and 200 mg QD, and exposure increased in a dose-proportional manner. Mean C avg values of CVC for the 100 and 200 mg dose corresponded ~88% and 95%, respectively, of the estimated C avg needed to achieve E max.

4 Table 2. Summary Noncompartmental Plasma CVC PK Parameters in Evaluable Subjects Treatment Variable N Geometric Mean Geometric CV% Min Max AUC 0-t (h*ng/ml) C avg (ng/ml) C max (ng/ml) C min (ng/ml) t 1/2 (h) T max (h) * AUC 0-t (h*ng/ml) C avg (ng/ml) C max (ng/ml) C min (ng/ml) t 1/2 (h) T max (h) * * Median provided for T max The plasma CVC C avg for one subject (blinded Subject Number 107), randomized to the dose group, was lower than the target range (ie, 55.6 to 722 ng/ml) on Day 14 with a concentration of 44.1 ng/ml. This incongruous data point was investigated and no obvious clinical reason (adherence, schedule of dose, food intake) was identified. To evaluate this subject further, this subject s trough samples (ie, predose) on Days 14 and 15 were compared to the trough concentration on Day 28 from the six other patients with available data at the time of the sample analysis. Geometric mean trough concentrations for all evaluable subjects on Days 14 and 28 are provided in Table 3. Predose concentrations on Day 14 and 15 for Subject 107 (18.6 and 15.9 ng/ml, respectively) appeared to be low relative to their corresponding group geometric mean. The trough concentration for Subject 107 on Day 28 (51.0 ng/ml) was consistent with the mean value of the group (59.5 ng/ml), suggesting that the unexpectedly low exposure to CVC on Day 14 for Subject 107 was transitory in nature. Trough concentrations were consistent between predose on Days 14 and 28, suggesting that steady state was achieved by Day 14 (Table 3). Table 3. Summary of Trough Plasma CVC Concentrations on Days 14 and 28 in Evaluable Subjects Treatment Predose N Geometric Mean (ng/ml) Geometric CV% Day Day Day Day Day Day

5 conclusions A planned interim PK analysis on plasma CVC concentrations following once-daily administration of CVC to HIV-1 infected subjects in ongoing Study 202 was performed. Summary results are presented below. C avg ranged from 44.1 to 159 ng/ml at the 100 mg CVC dose level and from 75.4 to 373 ng/ml at the 200 mg CVC dose level. C max was observed at 5 6 hours postdose for the low and high dose levels. Geometric mean values of C max for the 100 and 200 mg dose levels on Day 14 were 158 and 364 ng/ml, respectively. Plasma exposure to CVC appears to increase in a dose-proportional manner. Geometric mean C avg values of CVC for the 100 and 200 mg dose corresponded to ~88% and 95%, respectively, of the estimated C avg needed to achieve E max, suggesting that adequate exposure for virologic suppression was achieved for both dose levels. Study 202 is ongoing and will evaluate the efficacy and safety of CVC in treatment-naïve HIV-1 infected subjects. references 1. Marier JF, Trinh M, Pheng LH, Palleja SM, Martin DE. Pharmacokinetics and pharmacodynamics of TBR-652, a novel CCR5 antagonist, in HIV-1 infected, antiretroviral treatment-experienced, CCR5 antagonist-naive patients. Antimicrob Agents Chemother. 2011;55(6): Clinical Study Report : A Phase I, Fixed- Sequence, 4-Period, Cross-Over Pharmacokinetic Study of Two Test Formulations of TBR-652 in Fasted and Fed Healthy Volunteers. 15 June acknowledgements We would like to thank the Study investigators, site personnel and study subjects who are participating in this clinical trial and Charles Ballow, PharmD and the staff at Buffalo Clinical Research Center for their work on Study We also thank Sally Snyder and Rob Grosso for their assistance with preparation of this poster. The 19th Conference on Retroviruses and Opportunistic Infections March 5 8, 2012 Seattle, Washington

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