Mithra Announces Presentation of Positive Data on Estetrol (E4)
Native Estrogen at NAMS 2023
- Independent global leaders in medical
research on women’s health, Professor Amanda Black and Professor
Wulf Utian, to deliver two presentations each on E4
- E4 is a key active pharmaceutical
ingredient in Estelle® and
Donesta® products
- Differentiated efficacy and safety in
contraception and postmenopausal symptoms from positive Phase 3
trials
Liege,
Belgium,
27 September
2023 –
7:00
CEST – Mithra
(Euronext Brussels: MITRA), a company dedicated to Women’s Health,
today announces there will be four presentations on Estetrol (E4)
native estrogen at the North American Menopause Society (NAMS) 2023
Annual Meeting, being held September 27-30 in Philadelphia, USA. E4
is a key active pharmaceutical ingredient in both Mithra’s marketed
contraceptive Estelle® and its next generation hormone therapy
product candidate for postmenopausal symptoms, Donesta®.
Amanda Black MD, MPH, FRCSC, Professor
of Obstetrics and Gynecology at The University of Ottawa,
will hold an independent oral presentation on the use of E4 for
contraception and menopause. Dr. Black will be discussing the
science and safety behind the use of E4 in the menopause at the
opening symposium and will present some of the data on the effects
of E4 on breast tissue.
Dr. Wulf
Utian1, MD, PhD,
DSc, Executive Director Emeritus and Honorary
Founding President of NAMS, who is considered to be one of
the world’s authorities on menopause and women’s health, will hold
an oral presentation on the Phase 3 results of E4 in postmenopausal
symptoms. The data, from two multi-center, double-blind,
placebo-controlled trials with 2,550 postmenopausal women aged
40-65, show beneficial effects from 12-week treatment with E4.
These include a significant increase in high-density lipoprotein
(HDL) – or “good” – cholesterol and a significant decrease in the
ratio total of HDL cholesterol to low-density lipoprotein (LDL)
“bad” cholesterol and lipoprotein. There was also a significant
decrease in fasting plasma glucose and HbA1c average blood glucose
(glycemia) level. Also observed were trends for decreases in
insulin and Homeostatic Model Assessment for Insulin Resistance
(HOMA-IR).
Dr. Black and Dr. Utian will each also hold
poster presentations on E4 at NAMS 2023.
Graham Dixon, Chief
Scientific Officer of Mithra, commented: “The data will
demonstrate that E4 treatment has a favorable safety profile,
including a low impact on normal and malignant breast tissue,
thanks to its unique mode of action which means it has tissue
selective activity, unlike all other estrogens. It has also been
shown to be effective at decreasing vasomotor symptoms in
postmenopausal women. The evidence clearly shows the potential of
E4 to offer women differentiated options to support their
independence during child-bearing years and maintain their health
during menopause.”
Mithra has previously reported positive results
from Phase 3 trials, showing strong efficacy and a favorable safety
profile for contraception, for Estelle®, and separately, a
statistically significant reduction in vasomotor symptoms, or hot
flushes and night sweats, in postmenopausal women, with
Donesta®.
Dr.
David Horn Solomon, Chief
Executive Officer of
Mithra, commented: “We are proud that Dr. Black and Dr.
Utian, two globally recognized experts on women’s health, are
presenting this clinical research on our exciting E4 developments.
Our scientific founder, Professor Jean-Michel Foidart, was amongst
the first to characterize and recognize the potential of this
native and selective estrogen, which is produced by the human fetus
during pregnancy, passing into maternal blood at relatively high
levels and offering unique benefits. His research and development
efforts allowed Mithra to develop and test E4 as the key innovative
active pharmaceutical ingredient in Mithra’s oral contraceptive
Estelle® and its Donesta® next generation hormone therapy drug
candidate.
Our marketing partners are currently
accelerating the ongoing commercial launches of Estelle®, globally;
we are finalizing our application for U.S. marketing authorization
of Donesta®, for submission later this year. These data presented
at NAMS 2023 illustrate the significant goals we are pursuing to
provide women with a new era in oral contraception and the next
generation hormone therapy for menopause. Our mission is for these
and other innovative products to improve women’s health and
independence from young adulthood through mid-life and beyond.”
Details of the presentations at NAMS 2023 are as
follows:
- Estetrol
(E4): A Promising New Treatment for the Spectrum of Menopausal
Symptoms
Presenter:
Amanda Black – Poster
- The
Effect of Estetrol (E4) on Patient-Reported Outcome Measures in
Postmenopausal Women – Results From a Phase 3 Trial
Presenter:
Wulf Utian – Poster
- Estetrol
(E4), a Promising New Treatment for Menopausal Vasomotor Symptoms
(VMS): Beneficial Lipid and Carbohydrate Metabolism in a Phase 3
Randomized, Double-blind, Placebo-Controlled Trial
Presenter:
Wulf Utian – Oral
Time:
4:30-4:45pm EST, Thursday 28 September
Location:
Concurrent Session 2—Oral Abstract Presentations; Grand Ballroom
(A–D)—Fifth Floor
- Estetrol
(E4) for contraception and
Menopause: Where is the Science?
Presenter:
Amanda Black – Invited Oral (Independent)
Time:
10:10-10:30am EST, Wednesday 27 September
Location:
Opening Symposium—Precision Oncology for Midlife Women; Grand
Ballroom (E–L)—Fifth Floor
For more information, please
contact:
Mithra Pharmaceuticals SAAlex Sokolowski, PhDHead
of Investor Relationsinvestorrelations@mithra.com+32 (0)4 349 28
22 |
Frédérique DepraetereCommunications Directorinfo@mithra.com +32
(0)4 349 28
22 |
Chris MaggosCohesion Bureauchris.maggos@cohesionbureau.com+41 79
367 6254 |
|
|
|
About
Mithra
Mithra Pharmaceuticals SA (Euronext: MITRA) is a
Belgian biopharmaceutical company dedicated to transforming Women’s
Health by offering new choices through innovation, with a
particular focus on contraception and menopause. Mithra’s goal is
to develop products offering better efficacy, safety and
convenience, meeting women’s needs throughout their life span.
Mithra explores the potential of the unique native estrogen
estetrol in a wide range of applications in women health and
beyond. After having successfully launched the first estetrol-based
product in 2021, the contraceptive pill Estelle®, Mithra is now
focusing on its second product Donesta®, the next-generation
hormone therapy. Mithra also offers partners a complete spectrum of
solutions from early drug development, clinical batches and
commercial manufacturing of complex polymeric products (vaginal
ring, implants) and complex liquid injectables and biologicals
(vials, pre-filled syringes or cartridges) at its technological
platform Mithra CDMO. Active in more than 100 countries around the
world, is headquartered in Liège, Belgium. www.mithra.com
ESTELLE® and DONESTA® are registered trademarks
of Mithra Pharmaceuticals or one of its affiliates.
Important information
The contents of this announcement include
statements that are, or may be deemed to be, "forward-looking
statements". These forward-looking statements can be identified by
the use of forward-looking terminology, including the words
"believes", "estimates," "anticipates", "expects", "intends",
"may", "will", "plans", "continue", "ongoing", "potential",
"predict", "project", "target", "seek" or "should", and include
statements the Company makes concerning the intended results of its
strategy. By their nature, forward-looking statements involve risks
and uncertainties and readers are cautioned that any such
forward-looking statements are not guarantees of future
performance. The Company's actual results may differ materially
from those predicted by the forward-looking statements. The Company
undertakes no obligation to publicly update or revise
forward-looking statements, except as may be required by law.
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1 Dr. Utian is a member of the Mithra Advisory
Board.
- 2023-09-27_Mithra NAMS FR_Final
- 2023-09-27_Mithra NAMS_ENG_Final
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