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Tobira Therapeutics Inc. Presents Positive 48-Week Data From Phase 2b Trial of Cenicriviroc in Treatment-Naïve HIV Infection at the 14th European AIDS Conference


10/17/2013 7:08:04 AM

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Tobira Therapeutics Presents Positive 48-Week Data from Phase 2b Trial of Cenicriviroc in Treatment-Naïve HIV Infection at the 14th European AIDS Conference

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Tobira Therapeutics presented positive results from the 48-week analysis of the company’s Phase 2b (Study 202) clinical trial of cenicriviroc (CVC) today at the 14th European AIDS Conference taking place in Brussels, Belgium. CVC is a novel, oral, potent, once-daily, fixed-dose combinable dual CCR5 and CCR2 antagonist in late-stage clinical development for the treatment of HIV infection. Separately, Tobira also announced that it met with the U.S. Food and Drug Administration (FDA) for an End-of-Phase 2 meeting following the completion of Study 202. The FDA agreed with Tobira that the data from Study 202 support the initiation of Phase 3 studies and with Tobira’s plan to evaluate CVC in Phase 3 studies as a component of a nucleos(t)ide-sparing ‘backbone’ of cenicriviroc/lamivudine (CVC/3TC). In Phase 3 studies, CVC/3TC will be compared to tenofovir disoproxil fumarate/emtricitabine (TDF/FTC or Truvada®), both administered in combination with a third antiretroviral agent. Tobira is also developing CVC in three-drug fixed-dose combinations that could create new complete single-tablet regimen(s) in one pill, taken once-daily.

“The final 48-week data presented today confirm previously reported findings from the primary 24-week analysis presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2013. These data reinforce the positive results we have observed to date for cenicriviroc and add to our confidence that CVC holds potential to become an important component in the future treatment of HIV,” said Andrew Hindman, Tobira’s President and Chief Executive Officer. “We are also pleased that after reviewing the Phase 2b data, the FDA has agreed with Tobira's proposed plan to advance CVC/3TC into Phase 3 clinical development.”

“The time is right for novel HIV regimens with nucleos(t)ide-sparing backbones,” said Anton Pozniak, M.D., HIV Service Director, Chelsea and Westminster Hospital, London, UK.

Study 202 was a randomized, placebo-controlled, double-blind, double-dummy, dose-finding, 48-week study that enrolled 143 HIV treatment-naïve adult subjects with CCR5-tropic HIV infection (patients with CCR5-tropic virus represent approximately 80% of the treatment-naïve HIV-infected population). At week 48, CVC 100mg or CVC 200mg plus Truvada® (emtricitabine/tenofovir disoproxil fumarate) showed similar virologic success rates compared to Sustiva® (efavirenz or EFV) plus Truvada® (68% and 64% vs. 50%, FDA Snapshot Analysis-ITT). CVC was associated with a more favorable safety and tolerability profile compared to EFV, including a lower incidence of Grade 3 or higher adverse events (AEs) (4% for all CVC-treated subjects vs. 14% for EFV) and discontinuations due to AEs (1% for all CVC-treated subjects vs. 21% for EFV) reported. Total and LDL cholesterol levels decreased among subjects on CVC, while total, LDL and HDL cholesterol levels increased among subjects on EFV. The 48-week results from Study 202 were presented today by Judith Feinberg, MD, Professor at University of Cincinnati in the Antiretroviral Therapy session in a presentation titled: “Final Week 48 Analysis of Cenicriviroc (CVC) Compared to Efavirenz (EFV), in Combination with Emtricitabine/Tenofovir (FTC/TDF), in Treatment-Naïve HIV-1-Infected Adults with CCR5-Tropic Virus” (Abstract PS4/1).

Phase 3 Development Strategy: Based on the results of Study 202 and review of these outcomes and other data with the FDA, Tobira is preparing for CVC/3TC’s registration program. Tobira plans to conduct two randomized, controlled Phase 3 trials in treatment-naïve HIV-1 infected adults with CCR5-tropic HIV virus. These trials will evaluate efficacy and safety of CVC as a component of the novel nucleos(t)ide-sparing ‘backbone’ fixed-dose combination of CVC/lamivudine (3TC) compared to tenofovir disoproxil fumarate/emtricitabine (TDF/FTC, or Truvada®), when given in combination with a third antiretroviral agent. The trials will be designed with a 48-week primary endpoint to support global regulatory filings, and will continue for at least a total of 96 weeks. The trials will also assess the effect of CVC on inflammatory and metabolic parameters.

About Cenicriviroc

Cenicriviroc (CVC) is a novel, oral, potent, once-daily, fixed-dose combinable, dual antagonist of chemokine receptors CCR5 and CCR2. CVC is entering Phase 3 development for the treatment of HIV-1 infection, and is in preclinical development for fibrosis, GVHD, and other indications in which CCR5 and CCR2 play a role. The CCR5 receptor is the target used by the HIV virus to infect human T-cells. CCR2 is found on monocytes, macrophages, dendritic and hepatic stellate cells, which are implicated in several inflammation-mediated diseases, including liver fibrosis. Tobira’s HIV Phase 3 development program will evaluate CVC in fixed-dose combination tablets with other antiretroviral agents, for use in the treatment of HIV infection.

About Tobira Therapeutics

Tobira Therapeutics is a privately held biopharmaceutical company developing innovative therapies for treatment of HIV infection, fibrosis, GVHD, and certain oncology indications. The company’s lead development candidate is cenicriviroc (CVC), a novel, oral, potent, once-daily, fixed-dose combinable, dual inhibitor of chemokine receptors CCR5 and CCR2 in late-stage clinical development for the treatment of HIV. Tobira has financial support from a syndicate of leading life science investors including Domain Associates, Frazier Healthcare Ventures, Montreux Equity Partners, Novo Ventures and Canaan Partners. Learn more at www.TobiraTherapeutics.com.

Contact:

Tobira Therapeutics

Caroline Loewy, 650-741-6625

EVP & CFO

cloewy@tobiratherapeutics.com

or

BCC Partners for Tobira Therapeutics:

Karen L. Bergman, 650-575-1509

kbergman@bccpartners.com

Michelle Corral, 415-794-8662

mcorral@bccpartners.com

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