Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX:
TH) (NASDAQ: THTX), a biopharmaceutical company focused on the
development and commercialization of innovative therapies, today
announced results from a study evaluating an intramuscular (IM)
method of administration for Trogarzo® (ibalizumab-uiyk), a
monoclonal antibody antiretroviral therapy (ART) for the treatment
of heavily treatment-experienced adults with multidrug-resistant
(MDR) HIV-1 infection failing their current antiretroviral regimen.
The TMB-302 study, conducted in partnership with
TaiMed Biologics, enrolled 21 subjects (7 HIV-positive and 14
HIV-negative) to assess the pharmacokinetics, efficacy, and safety
of IM administration of Trogarzo® as compared to intravenous (IV)
infusion.
Mean Trogarzo® trough concentrations were
greater than 15 µg/mL, suggesting that IM injection was sufficient
at maintaining the drug trough concentration above the therapeutic
level of 0.3 µg/mL. The mean trough concentrations were comparable
between IV infusion and IM injection in HIV-positive subjects.
However, the primary endpoint measuring a 90% confidence interval
of the ratio of IM injection to IV infusion (0.69, 1.08) did not
meet the equivalence limits (0.8, 1.25). Viral suppression, a key
secondary clinical endpoint, was maintained in all HIV-positive
subjects throughout the IM phase and the overall study.
Each study subject received IM maintenance doses
for eight weeks of treatment and a total of 152 IM injections were
administered, which were well tolerated. One subject reported
injection-site pruritus (itching) at a single time point, and no
subjects reported injection-site pain when Trogarzo® was
administered intramuscularly.
With the TMB-302 data in hand, Theratechnologies
is seeking expert advice prior to completing a regulatory
submission of the Trogarzo® IM administration maintenance dose to
the U.S. Food and Drug Administration (FDA). The FDA is currently
reviewing the Company’s submission for the loading dose of the
Trogarzo® IV push method of administration and a decision is
expected in mid-December.
About
Trogarzo®
(ibalizumab-uiyk)
Trogarzo® (ibalizumab-uiyk) is a long-acting,
CD4-directed, post-attachment HIV-1 inhibitor. 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. Trogarzo® is not approved in Canada.
Trogarzo® is administered by intravenous
infusion as a single loading dose of 2,000 mg followed by a
maintenance dose of 800 mg every two weeks after dilution in 250 mL
of 0.9% Sodium Chloride Injection, USP. In October 2022, the
Trogarzo® maintenance dose was approved by the FDA to also be
administered as an undiluted IV push over 30 seconds.
Important Safety
Information
Do not receive Trogarzo® if you have had an
allergic reaction to Trogarzo® or any of the ingredients in
Trogarzo®. Trogarzo® can cause allergic reactions, including
serious reactions, during and after infusion. Tell your healthcare
provider or nurse, or get medical help right away if you experience
any symptoms of an allergic reaction. Before you receive Trogarzo®,
tell your healthcare provider about all of your medical conditions,
including 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 healthcare 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, and rash. Tell your healthcare provider if you have any
side effect that bothers you or that does not go away. These are
not all the possible side effects of Trogarzo®. For more
information, ask your healthcare provider or pharmacist.
Full prescribing information is available at
www.trogarzo.com.
About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a
biopharmaceutical company focused on the development and
commercialization of innovative therapies addressing unmet medical
needs. Further information about Theratechnologies is available on
the Company's website at www.theratech.com, on SEDAR
at www.sedarplus.ca, and on EDGAR at www.sec.gov.
Follow Theratechnologies
on Linkedin and Twitter.
Forward-Looking Information
This press release contains forward-looking
statements and forward-looking information (collectively, the
“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", “promising”, “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, statements regarding the
completion of a regulatory submission of the Trogarzo® IM
administration maintenance dose with the FDA and the timelines
about expected decision of the FDA on the Company’s submission for
the IV push method of administration of the Trogarzo® loading dose.
Certain assumptions made in preparing the Forward-Looking
Statements include that: we will file the regulatory submission of
the Trogarzo® IM administration maintenance dose with the FDA in
the last calendar quarter of 2023; the FDA will approve the IM
administration of Trogarzo® option for the maintenance dose and the
IV push method of administration of the Trogarzo® loading dose;
sales of Trogarzo® will increase with the addition of those two
methods of administration; and Trogarzo® will continue being
reimbursed by private and public payors. Forward-Looking Statements
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 Statements. These risks and
uncertainties include, but are not limited to, those related to or
arising from: a delay in the filing of the regulatory submission of
the Trogarzo® IM administration maintenance dose to the FDA; the
non-filing of the IM administration maintenance dose of Trogarzo®
with the FDA if experts recommend against it; the non-approval by
the FDA of the Trogarzo® IM administration maintenance dose and/or
the IV push method of administration of the Trogarzo® loading dose;
and, sales of Trogarzo® do not increase despite the approval by the
FDA of both or any one of those new methods of administration of
Trogarzo® . We refer current and potential investors to the “Risk
Factors” section of our Annual Information Form dated February 27,
2023, available on SEDAR at www.sedarplus.ca and on EDGAR at
www.sec.gov as an exhibit to our report on Form 40-F dated February
28, 2023, under Theratechnologies’ public filings for additional
risks involved in our business. 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.
Contacts:
Investor inquiries:Phillipe Dubuc Senior Vice President and
Chief Financial Officerpdubuc@theratech.com438-315-6608
Media inquiries:Julie SchneidermanSenior Director,
Communications & Corporate
Affairscommunications@theratech.com1-514-336-7800
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