Pairs Spruce’s Investigational Product
Candidate, Tildacerfont, with HMNC’s Companion Diagnostic, the
Proprietary Cortibon Genetic Selection Tool, to Treat MDD Patients
Responsive to CRF1 Receptor Antagonism
Provides Spruce with Option to In-License
Exclusive Worldwide Rights to Cortibon Following Completion of
Phase 2 Proof-of-Concept Study
HMNC to Initiate Phase 2 Study for the
Treatment of MDD in Q4 2024
Spruce Biosciences, Inc. (Nasdaq: SPRB) (“Spruce”), a late-stage
biopharmaceutical company focused on developing and commercializing
novel therapies for endocrine and neurological disorders with
significant unmet medical need, and HMNC Brain Health GmbH
(“HMNC”), a global precision psychiatry biopharma company,
announced today a strategic collaboration to develop Spruce’s
investigational product candidate, tildacerfont, a
second-generation CRF1 receptor antagonist, with HMNC’s companion
diagnostic, the proprietary Cortibon Genetic Selection Tool
(“Cortibon”), for the treatment of MDD.
“We believe that Cortibon has the potential to enable
tildacerfont to be advanced as a precision therapeutic for
personalized medicine in patients with MDD,” said Javier
Szwarcberg, M.D., M.P.H., Chief Executive Officer, Spruce
Biosciences. “Hyperactive corticotropin-releasing factor (CRF)
neurotransmission and CRF1 receptor signal transduction are
critical mechanisms for stress pathophysiology that may lead to
major depression. Tildacerfont may mediate responses to stress,
which has the potential to address up to 50% of the MDD patients
worldwide using Cortibon. We are excited to collaborate with HMNC
and initiate a Phase 2 proof-of-concept study of tildacerfont and
Cortibon for the treatment of MDD later this year.”
“Treatment of MDD is hampered by patient heterogeneity, meaning
many patients will fail to respond adequately to currently used
therapies. HMNC’s collaboration with Spruce marks a significant
step forward in our mission to bring innovative treatments to
patients with depression. Combining our companion diagnostic with
Spruce’s promising therapeutic offers a new avenue for precision
psychiatry,” said Dr. Maximilian Doebler, Chief Business Officer,
HMNC. “Traditional treatments often fall short, trapping patients
in a costly trial-and-error cycle. Our platform uses genetic
markers to predict responses to psychiatric medications,
potentially enhancing treatment efficacy and reducing costs. This
collaboration represents a new era in mental health
management.”
Under the agreement, HMNC will fund and conduct a Phase 2
proof-of-concept study of tildacerfont in MDD patients, who will be
screened using Cortibon. Spruce has an option to in-license
exclusive worldwide rights to Cortibon after completion of the
study, if results are positive. If Spruce exercises its option, it
will be responsible for the future worldwide development and
commercialization of tildacerfont and Cortibon for the treatment of
MDD under a collaboration framework that leverages HMNC’s ongoing
expertise in precision psychiatry and companion diagnostics.
Pursuant to the license terms, HMNC would be entitled to receive
certain milestone payments and tiered royalties on net sales of
tildacerfont in MDD.
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
brain and pituitary gland, where it is the primary regulator of the
hypothalamic–pituitary-adrenal (HPA) axis. By blocking the CRF1
receptor, tildacerfont has the potential to address hyperactive
brain CRF neurotransmission and aberrant functioning of the HPA
axis in patients with major depressive disorder (MDD). No
drug-related serious adverse events have been reported related to
tildacerfont treatment in completed studies.
About Cortibon
Cortibon is HMNC’s proprietary companion diagnostic,
representing a potentially groundbreaking approach in the treatment
of major depressive disorder (MDD). By utilizing genetic markers,
Cortibon aims to identify MDD patients who are more likely to
respond to CRF1 receptor antagonism, thereby enhancing treatment
outcomes and reducing the trial-and-error period typical in
depression treatment. Traditional treatments often lead to long
onset times and insufficient response rates, trapping patients in a
costly and prolonged trial-and-error cycle. Cortibon may
dramatically shift this paradigm by improving treatment efficacy
and reducing both costs and time.
About Spruce Biosciences
Spruce Biosciences is a late-stage biopharmaceutical company
focused on developing and commercializing novel therapies for
endocrine and neurological disorders with significant unmet medical
need. Spruce is developing its product candidate, tildacerfont, an
oral, second-generation CRF1 receptor antagonist, for the treatment
of congenital adrenal hyperplasia (CAH), polycystic ovary syndrome
(PCOS) and major depressive disorder (MDD). To learn more, visit
www.sprucebio.com and follow us on X @Spruce_Bio, LinkedIn,
Facebook and YouTube.
About HMNC Brain Health
HMNC Brain Health (HMNC Holding GmbH) is a global precision
psychiatry biopharma company headquartered in Munich, Germany,
which is pioneering the development of personalized therapies
powered by predictive companion diagnostics, leading to higher
remission rates in populations identified by companion diagnostics.
The company develops unique pipelines for targeting both major
depressive disorder (MDD) and treatment-resistant depression (TRD)
and has three depression development programs in Phase 2. The
company has presence in both Germany and the U.S. and is backed by
a renowned global VC, several family officers, and a strategic
healthcare investor. More information at
www.hmnc-brainhealth.com.
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 design, results, conduct,
progress and timing of Spruce’s clinical trials; Spruce’s
expectations regarding the initiation of the Phase 2 POC study of
tildacerfont and Cortibon in patients with MDD in the fourth
quarter of 2024; the potential for Cortibon to enable tildacerfont
to be advanced as a precision therapeutics for MDD and other
disorders; tildacerfont’s potential to mediate stress responses and
Spruce’s product candidate, strategy and regulatory matters.
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
“anticipate”, “may,” “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/20240604004940/en/
Spruce Media Katie Beach Oltsik Inizio Evoke Comms (937)
232-4889 Katherine.Beach@inizioevoke.com media@sprucebio.com
HMNC Media Anne Donohoe KCSA Strategic Communications
(732) 620-0033 hmncbrain@kcsa.com
Spruce Investors Samir Gharib President and CFO Spruce
Biosciences, Inc. investors@sprucebio.com
HMNC Investors Sophia Bashford KCSA Strategic
Communications (347) 487-6788 sbashford@kcsa.com
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