Trogarzo® Remains Effective Close to a Decade After Treatment
Initiation
Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ:
THTX), a commercial-stage biopharmaceutical company, is pleased to
announce that data presented at the 17th European AIDS Conference,
currently being held in Basel, Switzerland, demonstrate that
Trogarzo® (ibalizumab-uiyk) remains safe and effective in patients
having been on treatment for almost a decade.
Results come from a sub-analysis of patients
enrolled in study TMB-311. Patients in TMB-311 were enrolled in one
of two cohorts. Cohort 1 included 12 patients rolled over from an
Investigator-sponsored Investigational New Drug (PI-IND) protocol
upon completion of TMB-202, a Phase 2 clinical trial of Trogarzo®.
Cohort 1 also included 27 patients who had participated in the
Phase 3 clinical trial TMB-301.
At time of last TMB-311 visit, all 12 patients
rolled over from the Phase 2 clinical trial had an undetectable
viral load. Those patients had been treated with Trogarzo® and an
optimized background regimen for 7.8 years to 9.5 years (average
8.8 years).
Viral load suppression in patients rolled over
from TMB-301 was achieved in close to 60 percent of participants
(16/27).
TMB-311 also included 38 patients who had no
prior history of treatment with Trogarzo®. Those patients were part
of Cohort 2. After 48 weeks of treatment, 46% of Cohort 2 patients
still on treatment achieved a viral load below 50 copies/mL
(8/17).
In all cohorts, Trogarzo® was well tolerated and
no ibalizumab antibodies were observed in any patient.
About Trogarzo®
Trogarzo® is a CD4-directed post-attachment
HIV-1 inhibitor. Trogarzo® is approved for commercialization in the
United States and in the European Union. In the United States,
Trogarzo®, in combination with other antiretroviral(s), is
indicated for the treatment of human immunodeficiency virus type 1
(HIV-1) infection in heavily treatment-experienced adults with
multidrug resistant HIV-1 infection failing their current
antiretroviral regimen.
Before you receive Trogarzo®, tell your
healthcare provider if you are pregnant or plan to become pregnant
as it is not known if Trogarzo® may harm your unborn baby or if you
are breastfeeding or plan to breastfeed as it is not known if
Trogarzo® passes into breast milk.
Tell your healthcare provider about all the
medicines you take, including all prescription and over-the-counter
medicines, vitamins, and herbal supplements.
Changes in your immune system (Immune
Reconstitution Inflammatory Syndrome) can happen when you start
taking HIV-1 medicines. Your immune system might get stronger and
begin to fight infections that have been hidden in your body for a
long time. Tell your health care provider right away if you start
having new symptoms after starting your HIV-1 medicine.
The most common side effects of Trogarzo®
include: diarrhea, dizziness, nausea, cough, fatigue and rash.
These are not all the possible side effects of Trogarzo®. For more
information, ask your healthcare provider or pharmacist. Full
prescribing information available at www.trogarzo.com
About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a commercial-stage
biopharmaceutical company addressing unmet medical needs by
bringing to market specialized therapies for people with orphan
medical conditions, including those living with HIV. Further
information about Theratechnologies is available on the Company's
website at www.theratech.com, on SEDAR at www.sedar.com and on
EDGAR at www.sec.gov.
Forward-Looking Information
This press release contains forward-looking statements and
forward-looking information, or, collectively, forward-looking
statements, within the meaning of applicable securities laws, that
are based on our management’s beliefs and assumptions and on
information currently available to our management. You can identify
forward-looking statements by terms such as "may", "will",
"should", "could", “would”, "outlook", "believe", "plan",
"envisage", "anticipate", "expect" and "estimate", or the negatives
of these terms, or variations of them. The forward-looking
statements contained in this press release include, but are not
limited to, the safety and efficacy of Trogarzo®.
Forward-looking statements are based upon a
number of assumptions and are subject to a number of risks and
uncertainties, many of which are beyond Theratechnologies’ control
that could cause actual results to differ materially from those
that are disclosed in or implied by such forward-looking
information. These assumptions include but are not limited to, the
following: the safety and efficacy profile of Trogarzo® will be the
same for all patients as reported herein, no unknown material
adverse effects will be reported from the long-term use of
Trogarzo® and Trogarzo® will not be subject to recalls.
The risks and uncertainties include, among
others, that patients using Trogarzo® experience safety or efficacy
issues different than those referred to herein and that undesired
side effects are reported from the long-term use of Trogarzo® which
could lead to a black-box warning or a recall of the product.
We refer potential investors to the "Risk
Factors" section of our annual information form dated February 20,
2019 for additional risks regarding the conduct of our business and
Theratechnologies. The reader is cautioned to consider these and
other risks and uncertainties carefully and not to put undue
reliance on forward-looking statements. Forward-looking statements
reflect current expectations regarding future events and speak only
as of the date of this press release and represent our expectations
as of that date.
We undertake no obligation to update or revise
the information contained in this press release, whether as a
result of new information, future events or circumstances or
otherwise, except as may be required by applicable law.
For media inquiries:Denis BoucherVice President, Communications
and Corporate Affairs514-336-7800
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