Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX:
TH) (NASDAQ: THTX), a biopharmaceutical company focused on the
development and commercialization of innovative therapies, today
announced data from two poster presentations at the 24th
International AIDS Conference (“AIDS 2022”), being held from July
29 to August 2 in Montreal, Canada and virtually. The new data
provide key understandings on the potential of Trogarzo®
(ibalizumab) to evolve treatment paradigms for heavily
treatment-experienced HIV populations on complex regimens.
“Our sub-analysis showed that the combination of
the fully active ARVs with ibalizumab most influenced virologic
control with or without the partially active ARVs in combination,”
said Dr. Jason Leider, MD PhD, Professor of Medicine at Albert
Einstein College of Medicine, and lead author on Ibalizumab
long-term efficacy is not impacted by partially active
antiretrovirals. “We know that complex resistance profiles
often limit the number of fully active agents available. These
results demonstrate our focus should be on utilizing all available
fully active agents, which could lead to simpler regimens for this
heavily treatment-experienced population.”
This continuous genotypic susceptibility score
(cGSS) analysis, using the Stanford HIVdb (database), sought to
understand the contribution of partially active ARVs on durability
of response to Trogarzo with optimized background regimens (OBRs).
Trogarzo in combination with at least one fully active ARV remained
effective across a range of cGSS scores through week 96,
demonstrating its durability treating multidrug-resistant (MDR)
virus despite combination with compromised agents. The abstract was
selected as a top 300 abstract by AIDS 2022.
The second poster presentation at AIDS 2022
entitled Pharmacokinetic (PK) modeling and simulation of
intramuscular and subcutaneous ibalizumab delivery
highlights results from population PK modeling to simulate
intramuscular (IM) and subcutaneous (SC) dosing based on seven past
clinical studies with people living with HIV. The modelling was
completed using IM and SC administration to deliver 400 mg weekly
or 800 mg biweekly in 100 simulations. Both methods of
administration maintained trough concentrations greater than 0.3
μg/mL, which has been previously correlated with efficacy. These
data support the proof of concept that administration of Trogarzo
via both IM and SC injection weekly or every two weeks are
potential future improvements in convenience and accessibility. The
PK and safety of Trogarzo IM administration are currently being
evaluated in an open-label non-randomized phase 3 study.
The two AIDS 2022 scientific presentations come
on the heels of data presented at the Italian Conference on AIDS
and Antiviral Research (ICAR) entitled Evaluation of the in
vitro combinatorial activity of Ibalizumab and HIV-1
antivirals, which was supported by an independent grant.
In vitro combination activity between Trogarzo and nine other ARVs,
seven commercially available and two investigational, demonstrated
the additive or synergistic effects seen between each pairing. Of
note, synergistic activities were seen with dolutegravir,
etravirine, tenofovir alafenamide and lenacapavir, a long-acting
investigational ARV.
“We are proud to continue to investigate
improving treatment for people living with HIV on complex treatment
regimens. It is exciting to see new developments for this group,
many of whom have been taking numerous ARVs for years. The data
being presented at AIDS 2022 builds on the results shared at ICAR;
highlighting the need for further research so that more people
living with treatment-experienced HIV could ultimately benefit from
convenient regimens with long-acting agents,” said Dr. Christian
Marsolais, Chief Medical Officer, Theratechnologies.
Posters can be found at
www.aids2022.org and will be available following the
conference at www.theratech.com.
About
Trogarzo®
Trogarzo is a long-acting CD4-directed
post-attachment HIV-1 inhibitor. In the United States,
Trogarzo® (ibalizumab-uiyk), 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 (MDR) HIV-1
infection failing their current antiretroviral regimen. In the
European Union, Trogarzo® is approved for the
treatment of adults infected with MDR HIV-1 for whom it is
otherwise not possible to construct a suppressive antiviral
regimen.
Important Safety
Information
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 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.sedar.com and on EDGAR at www.sec.gov.
Forward-Looking Information
This press release contains forward-looking
statements and forward-looking information (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, statements regarding the
improvement of treatment for people living with HIV on complex
treatment regimens and the need for further research so that more
people living with treatment-experienced HIV could ultimately
benefit from convenient regimens with long-acting agents. Although
the Forward-Looking Statements contained in this press release are
based upon what the Company believes are reasonable assumptions in
light of the information currently available, investors are
cautioned against placing undue reliance on these statements since
actual results may vary from the Forward-Looking Statements.
Certain assumptions made in preparing the Forward-Looking
Statements include that: improved treatments for people living with
HIV on complex treatment regimens will be discovered, the IM
formulation of Trogarzo® will prove to be safe and effective and
the FDA will approve the IM formulation of Trogarzo®.
Forward-Looking Statements assumptions 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
the failure of the Phase 3 study to demonstrate safe and effective
IM mode of administration of Trogarzo® and the non-approval by the
FDA of such IM mode of administration. We refer current and
potential investors to the “Risk Factors” section of our Annual
Information Form dated February 23, 2022 available on SEDAR at
www.sedar.com and on EDGAR at www.sec.gov as an exhibit to our
report on Form 40-F dated February 24, 2022 under
Theratechnologies’ public filings for additional risks related to
the Company. 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:
Media inquiries:Julie SchneidermanSenior
Director, Communications & Corporate
Affairscommunications@theratech.com1-514-336-7800
Investor inquiries:Elif McDonaldSenior Director,
Investor Relationsir@theratech.com1-438-315-8563
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