MONTREAL, Oct. 4, 2017 /PRNewswire/
-- Theratechnologies Inc. (Theratechnologies) (TSX: TH) today
announced 48-week efficacy and safety results for ibalizumab in
patients infected with multidrug resistant HIV-1 who completed the
24-week Phase III study (TMB-301) and continued treatment in the
Expanded Access Program study (TMB-311). These data are being
presented in an oral presentation at IDWeek 2017™ in San Diego (abstract #1686).
Of the 27 patients who completed the 24-week treatment period of
TMB-301 in the U.S., all entered TMB-311, where patients continued
to receive ibalizumab at 800 mg every 2 weeks for up to 48 weeks.
The virologic suppression observed at week 24 was sustained through
week 48; median viral load reduction from baseline was
2.5log10 at weeks 24 and 48. In TMB-311, all 15 patients
with an undetectable viral load at week 24 maintained suppression
to week 48. Another patient in TMB-311 reached less than 50
copies/mL at week 48 after having a detectable viral load at week
24. A total of 17 patients (63%) achieved a viral load less than
200 copies/mL.
"As we await an FDA decision for ibalizumab, this long-term data
reinforces the critical role ibalizumab could have for patients
struggling with multidrug resistant HIV," said Luc Tanguay, President and Chief Executive
Officer, Theratechnologies Inc. "With the dramatic progress made
over the past two decades in treating HIV, the crucial need for new
treatments for these very vulnerable patients is often overlooked.
At Theratechnologies, focusing on these unmet needs is what we are
committed to doing, and ibalizumab is a prime example of that. We
thank both the patients and investigators for participating in this
important study."
In TMB-311, ibalizumab plus optimized background regimen (OBR)
was well tolerated; of the 27 patients in the study, 24 (89%)
continued to receive treatment until week 48 and 3 patients
discontinued early due to non ibalizumab-related reasons. No new or
unexpected safety concerns emerged between weeks 24 and 48. The
most common adverse reactions were diarrhea, dizziness, nausea and
rash.
"The participants enrolled in the Phase III study were highly
treatment experienced with limited antiretroviral options due to
drug resistance. As clinicians treating these patients,
having access to an agent with a novel mechanism of action was
critical," said Dr. Brinda Emu,
Assistant Professor of Medicine, Infectious Diseases, Yale School of Medicine, New Haven, CT. "Seeing sustained virologic
response out to 48 weeks is heartening and emphasizes the potential
benefit that ibalizumab may bring to HIV patients in need of new
treatment options."
About Study TMB-311
Of the 27 patients who completed the 24-week treatment period in
TMB-301 in the U.S., 27 entered TMB-311, the ibalizumab Expanded
Access Program, where patients continued to receive ibalizumab at
800 mg every 2 weeks for up to 48 weeks. Additionally, 59% and 33%
of the patients in the study had exhausted at least three or four
antiretroviral (ARV) classes, respectively, and 15% had HIV-1
resistant to all approved ARVs.
The Expanded Access Program is ongoing and enrolling patients.
For more information about TMB-311 (NCT02707861), please refer to
the ClinicalTrials.gov website (www.clinicaltrials.gov) or the
study website (www.ibalizumab-eap.com).
TMB-301 was a 24-week open-label study investigating the
efficacy and safety of ibalizumab plus OBR in highly treatment
experienced patients with multidrug resistant HIV.
About ibalizumab
Ibalizumab is an investigational humanized monoclonal antibody
being developed for the treatment of multidrug resistant HIV-1
infection. Unlike other antiretroviral agents, ibalizumab binds
primarily to the second extracellular domain of the CD4+ T cell
receptor, away from major histocompatibility complex II molecule
binding sites. It potentially prevents HIV from infecting CD4+
immune T cells while preserving normal immunological
function.
Ibalizumab is currently under accelerated review by the FDA
following the acceptance of a Biologics License Application on
June 30, 2017. The FDA target action
date to complete the review of ibalizumab is January 3, 2018.
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical
company addressing unmet medical needs to promote healthy living
and an improved quality of life among HIV patients. Further
information about Theratechnologies is available on the Company's
website at www.theratech.com and on SEDAR at www.sedar.com.
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 belief 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 approval of ibalizumab as a treatment for HIV
patients and the benefits of using ibalizumab as a treatment for
HIV patients.
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 FDA
will approve ibalizumab, patients and physicians will accept
ibalizumab as a treatment for HIV-infected patients (if approved),
treatment with ibalizumab will have the same effects as those
observed during the clinical trials and the Company will have
set-up on time the necessary infrastructure to launch ibalizumab as
a drug (if and when approved). These risks and uncertainties
include, but are not limited to, the risk that the FDA does not
approve ibalizumab for commercialization, that the effect of a
treatment using ibalizumab (if approved) will differ from those
observed during the clinical trials and that the Company is unable
to set-up its infrastructure on time to successfully launch
ibalizumab (if and when approved by the FDA).
We refer potential investors to the "Risk Factors" section of
our Annual Information Form dated February
7, 2017 available on SEDAR at www.sedar.com. 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.
Contact:
Philippe
Dubuc
Senior Vice President and Chief Financial Officer
Tel.: (514) 336-7800, ext. 297
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SOURCE Theratechnologies Inc.