– Company also provides update on timeline for
pivotal ZEPHYR study –
Millendo Therapeutics, Inc. (Nasdaq: MLND), a
late-stage biopharmaceutical company primarily focused on
developing novel treatments for orphan endocrine diseases,
announced today that Christophe Arbet-Engels, MD, PhD, has joined
the company as Chief Medical Officer. The company also announced
that it expects to report topline results from the Phase 2b portion
of its pivotal Phase 2b/3 clinical trial for livoletide in patients
with Prader-Willi syndrome (PWS), called ZEPHYR, early in the
second quarter of 2020.
“We are honored and excited to welcome Christophe to the team,”
said Julia C. Owens, PhD, President and Chief Executive Officer of
Millendo Therapeutics. “Christophe brings to Millendo broad
experience in endocrinology and guiding clinical stage therapies
through registration and lifecycle management. We believe this
expertise will be a significant asset with the data readout from
our pivotal clinical trial for livoletide in PWS anticipated in
early second quarter of this year and as we look ahead to potential
commercialization of our product candidates, including livoletide
for PWS.”
Dr. Arbet-Engels joins Millendo from Poxel Pharmaceuticals where
he was Chief Medical Officer, Executive Vice President Late
Development and Medical Affairs with responsibility for all medical
activities for Poxel’s portfolio, including driving portfolio
strategy and execution of registration programs. Previously, he
served as Vice President, Worldwide Medical, Collaborative Medical
Sciences at Biogen, where Dr. Arbet-Engels built, developed and led
global medical research, clinical operations,
biostatistics/analytics, communication and expanded access program
teams to advance the medical sciences in multiple therapeutic
areas. Dr. Arbet-Engels has also held several senior leadership
positions, globally and locally, in clinical development and
medical affairs at pharmaceutical and biotech companies including
Boehringer Ingelheim, Roche, Merck, Aventis (now Sanofi) and Ligand
Pharmaceuticals where he led the clinical development and
registration, launch and lifecycle management for several new
medicines. Dr. Arbet-Engels has a medical degree from University of
Paris Sud, a PhD in endocrinology/diabetes and metabolism from
University of Paris Descartes, and a master’s degree in business
administration from Rutgers University. He will be based in
Millendo’s Lexington, Massachusetts office.
“This is a very exciting time to join the talented team at
Millendo,” Dr. Arbet-Engels added. “With the data readouts from the
Phase 2b portion of the study for livoletide in PWS expected in
early second quarter of 2020 and for nevanimibe in classic
congenial adrenal hyperplasia (CAH) in the second half of the year,
I look forward to working closely with Julia and the rest of the
team to guide the company through the critical next steps for
advancing Millendo’s pipeline programs through development and into
commercialization.”
Inducement Equity Award On February 10, 2020, the
Compensation Committee of Millendo’s Board of Directors approved,
effective as of February 10, 2020, the grant of an inducement stock
option to purchase 140,000 shares of the Company’s common stock to
Dr. Arbet-Engels. The stock option awarded to Dr. Arbet-Engels will
have an exercise price equal to the closing price per share of the
Company’s common stock on February 10, 2020, and will vest and
become exercisable over four years, with 25% of the shares vesting
on February 10, 2021, the one-year anniversary of the vesting
commencement date, and the remaining shares vesting ratably over
the subsequent 36 months, subject to Dr. Arbet-Engels’ continued
service with the Company as of each such date. The stock option is
subject to acceleration if Dr. Arbet-Engels’ employment terminates
in connection with a change in control. The stock option has a
ten-year term and is subject to the terms and conditions of the
stock option agreement pursuant to which the option was
granted.
The stock option was granted as an inducement material to Dr.
Arbet-Engels entering into employment with the Company in
accordance with Nasdaq Listing Rule 5635(c)(4).
About Livoletide Livoletide is an unacylated ghrelin
analogue in late-stage clinical development for the treatment of
Prader-Willi syndrome (PWS), a rare genetic disease characterized
by hyperphagia, a chronic unrelenting hunger, that leads to
obesity, metabolic dysfunction, reduced quality of life and early
mortality. In a previous randomized, double-blind,
placebo-controlled Phase 2 clinical trial in 47 patients with PWS,
administration of livoletide once daily for two weeks was
associated with a clinically meaningful improvement in hyperphagia,
as well as a reduction in appetite. Millendo has received both
Orphan Drug Designation and Fast Track Designation for livoletide
for the treatment of PWS from the U.S. Food and Drug Administration
(FDA) and Orphan Drug Designation from the European Medicines
Agency (EMA). For more information about Millendo’s pivotal study
of livoletide (ZEPHYR) please visit www.clinicaltrials.gov
(NCT03790865) or the Patients and Families portion of our
website.
About Prader-Willi Syndrome Prader-Willi syndrome (PWS)
is a genetic disease caused by the lack of expression of several
genes on chromosome 15, which leads to hyperphagia, intellectual
disability, short stature and incomplete sexual development, among
other symptoms. PWS patients are at risk of premature mortality,
mainly from obesity related conditions such as cardiovascular
disease, respiratory distress and from accidents. The incidence of
PWS is approximately 1 in 15,000 births. The prevalence of PWS is
estimated between 8,000-11,000 patients in the United States and
13,000-18,000 in Europe. Currently, there is no effective or
approved treatment for hyperphagia and abnormal eating behaviors
associated with PWS. Growth hormone is used for improvement in
height, cognition and body composition, but has no effect on
appetite and over-eating. The only way to effectively manage
hyperphagia, obesity and related complications of PWS is strict
control over access to food, creating significant burden for
families and caregivers.
About the ZEPHYR study The ZEPHYR study is a two-part,
randomized, double-blind, placebo-controlled pivotal Phase 2b/3
study. The first part is a Phase 2b study that includes a
three-month double-blind, placebo-controlled core period in which
patients receive one of two doses of livoletide or placebo followed
by a nine-month extension period in which all patients receive
livoletide. The Phase 2b portion of the study, one of the largest
global PWS studies ever conducted, has completed recruitment for
patients ages 8 to 65 with over 150 patients across 39 clinical
sites in the United States, Europe and Australia. Millendo
continues to implement a protocol amendment globally adding an
additional cohort of PWS patients ages four to seven. Sites that
recruit pediatric patients will continue to actively recruit
patients for this cohort. The second part is a Phase 3 study that
will consist of a six-month double-blind, placebo-controlled core
period in which patients will receive livoletide or placebo
followed by a six-month extension period in which all patients
receive livoletide. The study’s primary endpoint measures the
change in food-related behaviors using the validated Hyperphagia
Questionnaire for Clinical Trials (HQ-CT) during each core period.
ZEPHYR is a pivotal study and the results of the Phase 2b portion
of the study may be sufficient to support a new drug application
(NDA) for livoletide.
About Millendo Therapeutics, Inc. Millendo Therapeutics
is a late-stage biopharmaceutical company primarily focused on
developing novel treatments for orphan endocrine diseases where
current therapies do not exist or are insufficient. As a leading
orphan endocrine company, Millendo seeks to create distinct and
transformative treatments where there is a significant unmet
medical need. The company is currently advancing livoletide for the
treatment of Prader-Willi syndrome, nevanimibe for the treatment of
classic congenital adrenal hyperplasia and MLE-301 for the
treatment of vasomotor symptoms associated with menopause. For more
information, please visit www.millendo.com.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release regarding
matters that are not historical facts, are forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended and Section 21E of the Securities Exchange Act
of 1934, as amended. These include statements regarding our plans
to develop and commercialize our product candidates and the
progress and timing of our ongoing and planned clinical trials for
our product candidates, and, therefore, you are cautioned not to
place undue reliance on them. In some cases, you can identify
forward-looking statements by the words “may,” “might,” “will,”
“could,” “would,” “should,” “expect,” “intend,” “plan,”
“objective,” “anticipate,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue” and “ongoing,” or the negative
of these terms, or other comparable terminology intended to
identify statements about the future. Such forward-looking
statements are based on Millendo’s expectations and involve risks
and uncertainties; consequently, actual results may differ
materially from those expressed or implied in the statements due to
a number of factors, including that Millendo has incurred
significant losses since inception, Millendo has a limited
operating history and has never generated any revenue from product
sales, Millendo will require additional capital to finance its
operations, Millendo's future success is dependent on the
successful clinical development, regulatory approval and subsequent
commercialization of livoletide, nevanimibe and any future product
candidates, preclinical studies or earlier clinical trials are not
necessarily predictive of future results and the results of
Millendo's clinical trials may not support Millendo's livoletide or
nevanimibe claims, Millendo may encounter substantial delays in its
clinical trials or Millendo may fail to demonstrate safety and
efficacy to the satisfaction of applicable regulatory authorities,
enrollment and retention of patients in clinical trials is an
expensive and time-consuming process and could be made more
difficult or rendered impossible by multiple factors outside
Millendo's control, Millendo's product candidates may cause
undesirable side effects or have other properties that could delay
or prevent their regulatory approval, or limit their commercial
potential and Millendo faces substantial competition. You should
refer to the risk factor disclosure set forth in the periodic
reports and other documents we file with the Securities and
Exchange Commission available at www.sec.gov, including without
limitation our including in the section entitled “Risk Factors” in
our Quarterly Report on Form 10-Q for our fiscal quarter ended
September 30, 2019 and subsequent reports that we file with the
Securities and Exchange Commission.
New factors emerge from time to time and it is not possible for
Millendo to predict all such factors, nor can Millendo assess the
impact of each such factor on the business or the extent to which
any factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statements. Forward-looking statements included in this press
release are based on information available to Millendo as of the
date of this press release. Millendo disclaims any obligation to
update such forward-looking statements to reflect events or
circumstances after the date of this press release, except as
required by applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20200210005223/en/
Millendo Investor Contact: Stephanie Ascher Stern
Investor Relations 212-362-1200 stephanie.ascher@sternir.com
Millendo Media Contact: Julie Bane MacDougall
617-821-1089 jbane@macbiocom.com
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