Tobira
Starts Phase 2b Cenicriviroc Trial
SUMMARY
Tobira Therapeutics recently opened a middle-phase trial
of its dual CCR5/CCR2 inhibitor cenicriviroc (TBR-652). |
Cenicriviroc
blocks both CCR5 -- 1 of the 2 co-receptors HIV uses to enter
cells -- and CCR2, a receptor that binds to monocyte chemoattractant
protein 1 (MCP-1), a chemical messenger that promotes migration
of monocytes and macrophages.
Though not fully understood, CCR2 plays a role in inflammation;
a growing body of evidence indicates that ongoing immune activation
and persistent inflammation contributes to non-AIDS conditions
such as cardiovascular disease in people with HIV.
In 2010 researchers presented data from a Phase 2a study of
cenicriviroc at the Retrovirus conference (CROI) and at the
International AIDS Conference in Vienna. Findings were recently
published in the June
1, 2011, Journal of Acquired Immune Deficiency Syndromes.
Below is an edited excerpt from a
recent Tobira press release describing the new trial now enrolling.
Tobira
Therapeutics Initiates Phase IIb Trial of Cenicriviroc, a
Novel CCR5/CCR2 Antagonist for the Treatment of HIV Infection
Enrollment
Begins in Study to Investigate Antiviral, Immunologic and
Anti-inflammatory Effects in HIV-infected Adults
Manalapan,
NJ -- June 22, 2011 -- Tobira Therapeutics, Inc., a biopharmaceutical
company focused on the development and commercialization of
innovative therapies for HIV, announced today that it has
initiated a Phase IIb clinical trial for the CCR5/CCR2 inhibitor
cenicriviroc (TBR-652). The multi-center, double-blind, double-dummy,
48-week comparative study is designed to evaluate the efficacy,
safety and tolerability of cenicriviroc in 150 HIV-1-infected,
antiretroviral treatment-naive patients with only CCR5-tropic
virus. The trial is actively enrolling patients in more than
50 sites across the United States and Puerto Rico.
Participants will receive either once-daily 100 mg or 200
mg doses of cenicriviroc in combination with emtricitabine/tenofovir
disoproxil fumarate (Truvada), or once-daily efavirenz (Sustiva)
plus Truvada. The trial's primary objective is to determine
the efficacy, safety and tolerability of each cenicriviroc
regimen versus the comparator regimen. The primary study analyses
will be performed at Week 24; the secondary analyses at Week
48. Additionally, several sub-studies will assess changes
in biomarkers associated with inflammation, cardiovascular
function, metabolic indicators of glucose control and immune
function.
"This study is based on the strength of the cenicriviroc
Phase IIa proof of concept, pharmacokinetic and safety findings
that were presented at key HIV/AIDS conferences and published
in peer-reviewed journals," said Melanie Thompson, MD,
of the AIDS Research Consortium of Atlanta, and a lead investigator
in Phase IIb study. "The study will further explore cenicriviroc's
antiviral activity and safety as well as effects on immunologic
and inflammatory biomarkers, including the effects of CCR2
receptor inhibition in HIV-1 infected patients."
"We're pleased to announce this significant development
milestone for cenicriviroc," said Andrew Hindman, President
and Chief Executive Officer. "The quality and range of
participating trial sites underscore the strong clinical interest
in cenicriviroc, which shows promise to be a truly transformational
HIV medicine with novel attributes. This study will establish
the optimal dose, evaluate the antiviral activity, safety
and tolerability and advance the understanding of the role
CCR2 blockade may have in mitigating some of the co-morbidities
associated with HIV infection."
For more information on the Phase IIb trial of cenicriviroc
in HIV-positive adults, please visit www.clinicaltrials.gov.
About Cenicriviroc (TBR-652)
Cenicriviroc
is a potent antagonist of CCR5, a co-receptor required for
HIV infection, and CCR2, a co-receptor involved in the inflammation
process that may play a key role in metabolic and cardiovascular
diseases. Well-differentiated from available and emerging
HIV medicines, cenicriviroc shows promise as a highly potent,
unboosted once-daily oral CCR5 antagonist with potentially
important CCR2-mediated anti-inflammatory effects.
Clinical data have been presented at key medical meetings
including last summer's International AIDS Conference and
the February 2010 and 2011 Conference on Retroviruses and
Opportunistic Infections (CROI). Key cenicriviroc data have
been published in peer-reviewed journals including the Journal
of Acquired Immune Deficiency Syndromes (Volume 57, Number
2, June 1, 2011) and Antimicrobial Agents and Chemotherapy
(Volume 55, Number 6, June, 2011).
6/28/11
Source
Tobira Therapeutics. Tobira Therapeutics Initiates Phase IIb
Trial of Cenicriviroc, a Novel CCR5/CCR2 Antagonist for the
Treatment of HIV Infection. Press release. June 22, 2011.
