Spruce Biosciences Provides Clinical Program Updates and Outlook for 2022
January 24 2022 - 8:00AM
Business Wire
Topline Data from CAHmelia-203 and CAHmelia-204
Anticipated in 2H 2023 and 2H 2024, Respectively
Strategic Reprioritization Extends Anticipated
Cash Runway by 6 Months into Q2 2024
CAHmelia Program in Adult Classic CAH to
Significantly Expand Sites Globally, Planned Increase of Up to 50
New Sites
Company Implementing Protocol Amendments to
Enhance Design of and Accelerate Patient Recruitment in
CAHmelia-203 and CAHmelia-204 Trials
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, today provided an update on its clinical programs,
upcoming milestones and strategic priorities for enhancing the
design of and accelerating patient recruitment into the CAHmelia
studies, which are evaluating tildacerfont for the treatment of
adult classic congenital adrenal hyperplasia (CAH).
“Following a comprehensive assessment of the CAHmelia program,
we’ve identified opportunities to accelerate patient recruitment
and enhance the designs of the studies evaluating the potential of
tildacerfont as a treatment for adult patients with classic CAH,”
said Javier Szwarcberg, M.D., MPH, Chief Executive Officer of
Spruce Biosciences. “By increasing the number of global trial sites
and effecting protocol amendments, we will be well-positioned to
meet our revised topline data milestones. In addition, we have
reprioritized activities which has enabled us to extend our
anticipated cash runway by approximately 6 months, taking us into
Q2 2024. We look forward to building momentum in 2022 with this new
focus, wherein we execute on our strategic business and clinical
objectives.”
Anticipated Milestones
- Completion of enrollment from the Phase 2 proof of concept
clinical trial in polycystic ovary syndrome (PCOS) by the end of
2022 and topline results by the first half of 2023
- Topline results from CAHmelia-203 in adult classic CAH patients
with poor disease control by the second half of 2023
- Topline results from CAHmelia-204 in adult classic CAH patients
with good disease control by the second half of 2024
Tildacerfont Program
Updates
Late-Stage CAHmelia Program in Adult Classic CAH
- Study Site Global Expansion for CAHmelia Program to Increase
Enrollment: To increase patient enrollment in Spruce’s
CAHmelia-203 and CAHmelia-204 studies, the company plans to
significantly expand the number of study sites by up to 50 new
sites, for a total of up to 130 sites worldwide. This includes
adding sites to currently selected regions in the United States,
Australia, Canada, Germany, Denmark, Spain, Italy, Netherlands,
Poland, Sweden, and the United Kingdom. Further, the company plans
to expand the study and identify sites within new countries. The
additional sites are anticipated to expand recruitment capabilities
to accelerate enrollment.
- Protocol Amendments to Enhance Recruitment in
CAHmelia-204: Following the completion of a full assessment of
the study protocol for the CAHmelia-204 study, Spruce is
implementing two key protocol changes: amending the androstenedione
(A4) inclusion criteria and eliminating the glucocorticoid
conversion requirement.
- Amending A4 Inclusion Criterion:
Spruce is amending the A4 inclusion criterion for the study from
≤1.5X to ≤2.5X the upper limit of normal (ULN). The amended A4
criterion will provide adult patients with slightly elevated A4
levels and baseline glucocorticoid regimen of ≥30 mg/d
hydrocortisone equivalent (HCe) the opportunity to enter the study
and reduce glucocorticoid usage according to a study protocol
pre-defined algorithm. Based on current screening to date, the
amended criterion is anticipated to increase enrollment into
CAHmelia-204.
- Elimination of Glucocorticoid Conversion
Requirement: Under the revised protocol, patients enrolling
in the study will be allowed to continue their existing
glucocorticoid regimen while receiving study drug. Previously,
patients in the study were required to convert their existing
glucocorticoid regimen to sponsor-provided glucocorticoids as
outlined in the study protocol, a requirement that led to declining
interest in the study. To accommodate this protocol amendment, the
company will implement a robust accounting system to track
glucocorticoid use and compliance for study participants.
- Protocol Amendments to Enhance Designs of CAHmelia-203 and
CAHmelia-204: Following the completion of a full assessment of
the CAHmelia-203 and CAHmelia-204 study protocols, Spruce is
amending the primary endpoint in CAHmelia-204 and adjusting the A4
and adrenocorticotropic hormone (ACTH) inclusion criteria in
CAHmelia-203.
- Amending Primary Endpoint of CAHmelia-204
to a Responder Analysis: Spruce is amending the primary
endpoint of CAHmelia-204 assessed at Week 24 from an absolute
change in HCe to a responder analysis evaluating the proportion of
patients with ≥5 mg/d HCe dose reduction while maintaining an A4
level within normal limits. A 5 mg/d HCe reduction while
maintaining androgen control is considered a clinically important
outcome and reflects a measure of individual clinical benefit for
each study subject. Change in HCe will become a key secondary
endpoint under the revised protocol.
- Amending A4 and ACTH Inclusion Criteria
in CAHmelia-203: Spruce is increasing the A4 inclusion
criterion to >2.5X the ULN and is removing the ACTH inclusion
criterion as the A4 level inclusion criterion alone provides
sufficient evidence of excessive adrenal stimulation by ACTH.
- Implementation of Optional Pre-Screening Protocol:
Spruce will be implementing an optional pre-screening protocol to
enable prompt determination of key inclusion criteria under the
revised CAHmelia-203 and CAHmelia-204 study protocols. The
pre-screening protocol streamlines screening activities for both
CAHmelia-203 and CAHmelia-204 into a single protocol and is
anticipated to increase overall screening and allow for more
efficient assessment of eligibility by study sites into either
CAHmelia-203 or CAHmelia-204.
Pediatric Classic CAH Program
- Phase 2 Clinical Trial in Pediatric Classic CAH Now
Initiated: Spruce is investigating tildacerfont for the
treatment of classic CAH in children and recently initiated a Phase
2 clinical trial. There is a significant medical need to bring
androgen-lowering and glucocorticoid-sparing therapies to pediatric
classic CAH patients to reduce the risk of premature puberty and
the adverse effects of glucocorticoids, including stunted growth
resulting in short stature as adults. The Phase 2 open-label
clinical trial will utilize a sequential 3 cohort design to
evaluate the safety, pharmacokinetics, and exploratory
pharmacodynamics of tildacerfont in children 6 to 17 years of age
with classic CAH.
- Pediatric Investigational Plan (PIP) for Tildacerfont
Adopted by European Medicines Agency (EMA): The Pediatric
Committee (PDCO) of the EMA adopted a positive opinion on its
agreement with the proposed PIP of tildacerfont for the treatment
of CAH. The PIP opinion from PDCO endorsed the clinical program to
evaluate the safety, tolerability and efficacy of tildacerfont for
the treatment of CAH in patients from one year of age to less than
18 years of age. PDCO also granted a waiver for the treatment of
CAH in patients less than one year of age. The adoption of the PIP
paves the way for the initiation of a Phase 3 registrational
program in pediatric classic CAH following a successful completion
of the current Phase 2 clinical trial.
Polycystic Ovary Syndrome (PCOS) Program
- Phase 2 Proof of Concept Clinical Study in PCOS Now
Initiated: Spruce recently initiated a randomized,
placebo-controlled, dose escalation study which will evaluate the
safety and efficacy of tildacerfont titrated to 200 mg once daily
compared to placebo at 12 weeks in subjects with PCOS and elevated
adrenal androgens as measured by dehydroepiandrosterone sulfate
(DHEAS) levels at baseline. PCOS is a hormonal disorder common
among females of reproductive age characterized by hirsutism,
irregular periods, and ovarian cysts. Adrenal androgen
overproduction is thought to contribute to the clinical
manifestations of PCOS in some patients. By reducing
ACTH-stimulated adrenal androgen production, tildacerfont has the
potential to treat the clinical sequelae of PCOS.
Financial Update
The company estimates that its cash, cash equivalents, and
investments were $121.4 million as of December 31, 2021. This
amount is unaudited and preliminary and is subject to completion of
financial closing procedures.
Strategic prioritization of activities has resulted in projected
program cost reductions and deferrals of expenditures that are
aligned with updated program timelines. Spruce has extended its
expected cash runway by approximately 6 months, from Q4 2023 into
Q2 2024.
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). Classic CAH is a serious and life-threatening disease with
no known novel therapies approved in approximately 50 years. Spruce
is also developing tildacerfont for women suffering from a rare
form of 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 results, conduct, progress and
timing of Spruce’s clinical trials, including the impact of the
strategies to enhance the design of and accelerate patient
recruitment into the CAHmelia studies, the fulfillment of Spruce’s
strategic business objectives, the advancement of Spruce’s drug
development pipeline, and Spruce’s expectations regarding its
extended cash runway. 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 “plans”, “will”, “believe”, “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 the COVID-19 pandemic, 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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Media Contact Will Zasadny Canale Communications (619)
961-8848 will.zasadny@canalecomm.com media@sprucebiosciences.com
Investors Xuan Yang Solebury Trout (415) 971-9412
xyang@soleburytrout.com investors@sprucebiosciences.com
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