Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ:
THTX), a biopharmaceutical company focused on the development and
commercialization of innovative therapies, is pleased to announce
that new data, demonstrating the positive effect of tesamorelin on
the circulation of immune activation markers associated with liver
inflammation, was presented today at The Endocrine Society’s annual
meeting, ENDO 2021.
Dr. Takara L. Stanley, Assistant Professor of
Pediatrics, Harvard Medical School, Assistant Pediatrician,
Massachusetts General Hospital and Program Director, Pediatric
Endocrine Fellowship Program, MGHfC, authored the poster presented
at ENDO 2021.
The data comes from a sub-analysis of a
double-blind, randomized, 12-month investigator-initiated trial
studying the effect of tesamorelin on liver fat in 61 people
infected with HIV with nonalcoholic fatty liver disease (NAFLD)
which was conducted by Dr. Steven Grinspoon, Professor of Medicine,
Harvard Medical School, Chief of the Metabolism Unit at
Massachusetts General Hospital. Dr. Grinspoon’s findings were
published in The Lancet HIV in October 2019.
The sub-analysis concludes that treatment with
tesamorelin for 12 months decreased circulating markers of T-cell
and monocyte/macrophage activity. A corresponding downregulation of
immune pathways in the liver was also observed. These conclusions
suggest that treatment with tesamorelin may contribute to better
regulated immune activation in a population with metabolic
dysregulation and systemic inflammation.
“The data presented at ENDO 2021 highlights
tesamorelin’s unique mechanism of action that addresses the
underlying cause of liver disease and further supports the Phase 3
development of this novel medicine for the potential treatment of
NASH,” said Dr. Christian Marsolais, Senior Vice President and
Chief Medical Officer at Theratechnologies.
The presentation abstract is available at:
https://www.abstractsonline.com/pp8/#!/9188/presentation/2240
Phase 3 clinical trialThe
proposed Phase 3 clinical trial design will enroll participants
with liver-biopsy confirmed NASH and stage 2 or 3 fibrosis.
Participants will be randomized 1:1 to receive 2 mg of tesamorelin
or placebo. A second liver biopsy will be performed after 18 months
of treatment for the first 900 participants, approximately. These
data will form the basis for filing an sBLA with the U.S. Food and
Drug Administration (FDA) to seek accelerated approval. The primary
endpoint used to seek accelerated approval will be the percentage
of participants achieving NASH resolution and no worsening of
fibrosis compared to placebo. Participants will remain in the Phase
3 trial for a total of 60 months. Subject to additional discussions
with regulatory agencies, approximately 2,000 participants in total
are expected to be enrolled, including a cohort of approximately 75
to 100 participants with HIV.
In late December 2020, the Company received a
“Study May Proceed” letter for the Phase 3 trial from the FDA with
a recommendation that the Company requests a meeting to discuss
questions and comments provided on certain aspects of the proposed
trial design. The Company has formally requested a meeting with the
FDA to ensure alignment with current regulatory expectations for
the late-stage development of treatments for NASH. The Company is
assessing its strategy regarding a filing with the EMA to initiate
a Phase 3 clinical trial of tesamorelin for the treatment of NASH
in the European Union.
The Company plans to initiate the Phase 3
clinical trial by the end of the third quarter of calendar year
2021. The timing of the trial initiation and the final number of
patients enrolled are dependent upon any adjustments to the
protocol and trial design as recommended by the FDA and EMA. The
Company has retained the services of a global, large-scale contract
research organization, or CRO, with experience in implementing
large and late-stage clinical trials to assist with the execution
of its Phase 3 clinical trial in NASH.
About NAFLD /NASHAccording to
the National Institute of Diabetes and Digestive and Kidney
Diseases of the National Institutes of Health, experts estimate
that 20 percent of Americans with NAFLD have NASH. It is believed
that 3 to 12 percent of adult Americans have NASH.1
NAFLD is an umbrella term for a spectrum of
liver conditions that begin with a build-up of hepatic fat, which
can set the stage for inflammation that may promote scarring known
as fibrosis. Over time, fibrosis can progress to potentially fatal
cirrhosis and even a form of liver cancer called hepatocellular
carcinoma.
Usually, NAFLD and NASH are silent diseases with
few or no symptoms. A patient may not show symptoms even if they
develop cirrhosis due to NASH.
There is currently no approved treatment for
NAFLD and NASH in the North America and Europe.
About
TheratechnologiesTheratechnologies (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 InformationThis
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, statements regarding the development of tesamorelin for
the treatment of NASH, the timelines related to the beginning of
the Phase 3 clinical trial the enrollment of patients and the study
duration, as well statements regarding the number of U.S. patients
suffering from NASH.
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: tesamorelin will be shown as a safe and effective drug
for the treatment of NASH in the general population, tesamorelin
data and results monitored to date will continue to be observed in
the Phase 3 trial, the various timelines set forth in this
press release will be met, the Phase 3 study protocol will be
approved by both the FDA and the European regulatory agencies, we
will succeed in enrolling a sufficient number of patients to
conduct the Phase 3 trial and we will have enough funds to conduct
the Phase 3 development of tesamorelin in the general population
suffering from NASH and to execute on our business plan.
The risks and uncertainties include, among
others, the risk that tesamorelin does not prove to be a safe and
effective drug for the treatment of NASH, that we do not meet the
endpoints of the Phase 3 trial, that we are unable to enroll a
sufficient number of patients to show clinical benefits from the
use of tesamorelin, that unknown side effects of tesamorelin are
discovered, that our intellectual property is challenged and held
to be invalid or infringing upon third parties’ intellectual
property, that we do not have enough funds to finance the Phase 3
trial and our business plan, that competing drugs are or may become
available and more successful, that performance of third-party
suppliers and manufacturers we are relying on may be deficient,
that expenses, revenues and capital requirements vary from our
estimates, that conditions may be imposed by regulatory authorities
on the marketing approvals of our products, that we are unable to
adequately service the markets for our products, and that there is
a poor rate and degree of market acceptance of our products.
We refer potential investors to the "Risk
Factors" section of our annual information form dated February 24,
2021 and to our Form 40-F dated February 25, 2021 filed on EDGAR
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
For investor inquiries:Leah GibsonSenior Director, Investor
Relations617-356-1009
1
https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/definition-facts#:~:text=Experts%20estimate%20that%20about%2020%20percent%20of%20people%20with%20NAFLD%20have%20NASH.&text=Between%2030%20and%2040%20percent,the%20United%20States%20have%20NASH.
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