Javier Szwarcberg, M.D., M.P.H., Chief
Executive Officer, accepted the Corporate Partner Award
Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage
biopharmaceutical company focused on developing and commercializing
novel therapies for rare endocrine disorders with significant unmet
medical need, was honored by the CARES Foundation, Inc. for its
ongoing development of tildacerfont for patients with classic
congenital adrenal hyperplasia (CAH). The CARES Foundation is the
only U.S.-based nonprofit organization solely dedicated to
improving the lives of the CAH patient community and seeks to
advance quality health care. Spruce Biosciences’ Chief Executive
Officer, Javier Szwarcberg, M.D., M.P.H., accepted the Corporate
Partner Award at the 15th Annual Everyone CARES Gala held in New
York City on May 20.
“This recognition is a testament to our team’s efforts in
bringing novel solutions to the patient communities we aim to
serve. Spruce is honored to receive this award as we endeavor to
open a new chapter in the management of CAH with tildacerfont, a
potentially life-changing medicine,” said Dr. Javier Szwarcberg,
Chief Executive Officer of Spruce Biosciences. “We are dedicated to
making progress, leveraging breakthrough science, and delivering a
quantifiable and meaningful improvement over today’s standard of
care. This is an incredibly important time for the CAH patient
community.”
“Spruce has been a terrific partner from the very beginning of
its CAH program,” said Dina Matos, Executive Director of CARES
Foundation. “Their support of our community is worthy of
recognition and that’s why they have been selected to receive this
year’s Corporate Partner Award.”
CAH is a genetic disorder that impacts approximately 20,000 to
30,000 people in the United States and approximately 50,000 people
in the European Union throughout their entire lives. CAH affects
the adrenal glands, leading to an inability to make cortisol, a
stress hormone necessary for life, and an overproduction of adrenal
androgens. Due to the severity of the disease, most developed
nations across the world have established newborn screening
programs. The overproduction of adrenal androgens can lead to
life-compromising effects such as early puberty, overweight, short
stature, acne, facial hair in females, acne, psychological effects,
and impaired fertility in both sexes.
For approximately 70 years, glucocorticoid treatment, often at
supraphysiologic doses, has been the standard of care to reduce
adrenal androgen levels. However, supraphysiologic doses of
glucocorticoids over a lifetime present serious side effects
including cardiovascular complications, hypertension, insulin
resistance, high lipids, cushingoid appearance, and bone loss
resulting in fractures. Spruce is developing tildacerfont, an
investigational once-daily, non-steroidal tablet designed to
inhibit the production of adrenal androgens and potentially enable
people with CAH to reduce their daily glucocorticoid doses to
physiologic replacement levels.
Spruce is currently conducting the CAHmelia program in adults
(18 years of age and older) and the CAHptain program in children
and adolescents (2 to 17 years of age) with classic CAH. As part of
the CAHmelia and CAHptain clinical programs, study participants who
complete these studies will be eligible to continue receiving
tildacerfont as part of an open-label extension.
About Congenital Adrenal Hyperplasia (CAH)
CAH is an autosomal recessive disease, driven by a mutation in
the gene that encodes an enzyme necessary for the synthesis of key
adrenal hormones. In CAH patients, the body is not able to produce
cortisol, leading to serious health consequences. The absence of
cortisol alters the normal feedback cycle of the
hypothalamic-pituitary-adrenal (HPA) axis and leads to excess
secretion of adrenocorticotropic hormone (ACTH), hyperplasia of the
adrenal gland, and consequently high levels of endogenous androgen
production. As a result, CAH patients suffer from premature
puberty, impaired fertility, hirsutism, acne, the development of
adrenal rest tumors, and an impaired quality of life, and
additionally for females, virilized genitalia and menstrual
irregularities. Currently, the only way to downregulate the
production of excess androgens in CAH patients is to administer
supraphysiologic doses of glucocorticoids, which present specific
side effects, including increased risks of developing diabetes,
cardiovascular disease, stunted growth, osteoporosis, thin skin,
gastrointestinal disorders, and decreased lifespan.
About Tildacerfont
Tildacerfont is a potent and highly selective, non-steroidal,
oral antagonist of the CRF1 receptor, which is the receptor for
corticotropin-releasing factor (CRF), a hormone that is secreted by
the hypothalamus. The CRF1 receptor is abundantly expressed in the
pituitary gland where it is the primary regulator of the HPA axis.
By blocking the CRF1 receptor, tildacerfont has the potential to
address the uncontrolled cortisol feedback regulatory pathway in
CAH, and in turn reduce the production of ACTH in the pituitary,
limiting the amount of androgen produced downstream from the
adrenal gland. By controlling excess adrenal androgens through an
independent mechanism, tildacerfont has the potential to reduce the
unwanted clinical symptoms associated with high androgen exposure
and could also enable treating physicians to lower the
supraphysiologic glucocorticoid doses given to CAH patients to near
physiologic levels. Tildacerfont has been evaluated in over 200
subjects across eight completed clinical trials in which it has
been generally well tolerated. No drug-related SAEs have been
reported related to tildacerfont treatment in completed
studies.
About CAHmelia and CAHptain Studies
Spruce Biosciences is currently conducting studies of
tildacerfont in adults (18 years of age and older) and children and
adolescents (ages 2 to 17 years of age) with classic CAH. For more
information about the adult CAHmelia program, please visit
https://www.sprucebio.com/cahmelia. For more information about the
pediatric CAHptain program, please visit
https://www.sprucebio.com/cahptain. As part of the CAHmelia and
CAHptain clinical programs, study participants who complete these
studies will be eligible to continue receiving tildacerfont as part
of an open-label extension.
About Spruce Biosciences
Spruce Biosciences is a late-stage biopharmaceutical company
focused on developing and commercializing novel therapies for rare
endocrine disorders with significant unmet medical need. Spruce is
initially developing its wholly-owned product candidate,
tildacerfont, as the potential first non-steroidal therapy for
patients suffering from classic congenital adrenal hyperplasia
(CAH). Spruce is also developing tildacerfont for women suffering
from polycystic ovary syndrome (PCOS) with primary adrenal androgen
excess. To learn more, visit www.sprucebiosciences.com and follow
us on Twitter @Spruce_Bio, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such forward-looking statements include statements
regarding, among other things, the enrollment, results, conduct,
progress and timing of Spruce’s clinical trials and tildacerfont
being a potentially life-changing medicine and potentially enabling
people with CAH to reduce their daily glucocorticoid doses to
physiologic replacement levels. Because such statements are subject
to risks and uncertainties, actual results may differ materially
from those expressed or implied by such forward-looking statements.
Words such as “aim,” “anticipate”, “enable,” “expect”, “will”,
“potential” and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are
based upon Spruce’s current expectations and involve assumptions
that may never materialize or may prove to be incorrect. Actual
results could differ materially from those anticipated in such
forward-looking statements as a result of various risks and
uncertainties, which include, without limitation, risks and
uncertainties associated with Spruce’s business in general, the
impact of geopolitical and macroeconomic events, and the other
risks described in Spruce’s filings with the U.S. Securities and
Exchange Commission. All forward-looking statements contained in
this press release speak only as of the date on which they were
made and are based on management’s assumptions and estimates as of
such date. Spruce undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made, except as required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230522005188/en/
Media Will Zasadny Evoke Canale (619) 961-8848
will.zasadny@evokecanale.com media@sprucebiosciences.com
Investors Xuan Yang Solebury Strategic Communications
(415) 971-9412 xyang@soleburystrat.com
investors@sprucebiosciences.com
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