Solid Biosciences Announces Organizational Changes to Prioritize Development of SGT-001
January 09 2020 - 8:00AM
Solid Biosciences Inc. (Nasdaq: SLDB) today announced changes to
its organizational structure to create a leaner company focused on
advancing SGT-001, a gene transfer candidate for the treatment of
Duchenne muscular dystrophy (Duchenne). In December 2019, the
company reported biomarker data from two patients that provide
evidence that SGT-001 is biologically active with differentiated
properties which Solid believes warrants further evaluation.
“We believe SGT-001 holds great potential for the treatment of
Duchenne, and in order to effectively evaluate its potential for
patients, we made some difficult choices to focus our resources and
help extend our cash runway,” said Ilan Ganot, Chief Executive
Officer, President and Co-Founder of Solid Biosciences. “We are
grateful for the efforts and contributions of our employees who
have worked tirelessly to advance our mission to improve the lives
of patients with Duchenne. We are committed to supporting all
employees during this transition.”
In November 2019, Solid announced that the SGT-001 IGNITE DMD
trial was placed on clinical hold by the U.S. Food and Drug
Administration (FDA). Going forward, the company will focus on
conducting its analyses of SGT-001 to determine how to address the
clinical hold and resume dosing. The activities supporting the
company’s other research and development programs will be curtailed
as Solid establishes a path forward for SGT-001. As part of the
organizational changes, the company will reduce its work force by
approximately one third. In conjunction, Chief Operating Officer
Alvaro Amorrortu, M.B.A. and Chief Medical Officer Jorge Quiroz,
M.D., M.B.A. will depart the company but will continue as advisors
to Solid.Industry veterans Cathryn Clary, M.D., M.B.A., and Jeffry
Lawrence, M.D., who have been working with Solid during the past
several months, will now provide leadership and additional support
for the company’s clinical and regulatory activities. Dr. Clary
will work closely with the clinical committee of Solid’s board of
directors to lead and coordinate these activities.
“I would like to thank Alvaro and Jorge for their contributions
to Solid over the last several years. Their leadership and
dedication to advancing meaningful new therapies for patients with
Duchenne has been commendable and we wish them the best in their
future endeavors. While Solid will look a little different as we
move into 2020, our unwavering commitment to the Duchenne community
remains strong. We are focused on the work ahead to determine the
best approach to resume dosing of SGT-001,” continued Mr.
Ganot.
The corporate changes implemented will result in a reduction in
corporate expenses and, based on the company’s current operating
plans, are expected to extend the cash runway into 2021.
About SGT-001Solid’s SGT-001 is a novel
adeno-associated viral (AAV) vector-mediated gene transfer therapy
under investigation for its ability to address the underlying
genetic cause of Duchenne muscular dystrophy (Duchenne). Duchenne
is caused by mutations in the dystrophin gene that result in the
absence or near absence of dystrophin protein. SGT-001 is a
systemically administered candidate that delivers a synthetic
dystrophin gene, called microdystrophin, to the body. This
microdystrophin encodes for a functional protein surrogate that is
expressed in muscles and stabilizes essential associated proteins,
including neuronal nitric oxide synthase (nNOS). Data from Solid’s
preclinical program suggests that SGT-001 has the potential to slow
or stop the progression of Duchenne, regardless of genetic mutation
or disease stage.
SGT-001 is based on pioneering research in dystrophin biology by
Dr. Jeffrey Chamberlain of the University of Washington and Dr.
Dongsheng Duan of the University of Missouri. SGT-001 has been
granted Rare Pediatric Disease Designation, or RPDD, in the United
States and Orphan Drug Designations in both the United States and
European Union.
About Solid BiosciencesSolid Biosciences is a
life science company focused solely on finding meaningful therapies
for Duchenne muscular dystrophy (Duchenne). Founded by those
touched by the disease, Solid is a center of excellence for
Duchenne, bringing together experts in science, technology and care
to bring forward meaningful therapies that have life-changing
potential. For more information, please visit www.solidbio.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements regarding the Company’s workforce
reduction, reduction in corporate expenses and cash runway the
Company’s IGNITE DMD clinical trial and other statements containing
the words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “would,” “working” and similar
expressions. Any forward-looking statements are based on
management’s current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in,
or implied by, such forward-looking statements. These risks and
uncertainties include, but are not limited to, risks associated
with the Company’s ability to successfully implement its workforce
reduction plan and reduce expenses; the impact of the workforce
reduction on the Company’s business; the ability of the Company to
attract and retain qualified personnel; the Company’s ability to
satisfactorily respond to requests from the FDA for further
information and data regarding IGNITE DMD; successfully resolve the
clinical hold with regard to IGNITE DMD; obtain and maintain
necessary approvals from the FDA and other regulatory authorities
and investigational review boards at clinical trial sites; enroll
patients in its clinical trials; continue to advance SGT-001 in
clinical trials; replicate in clinical trials positive results
found in preclinical studies and earlier stages of clinical
development; advance the development of its product candidates
under the timelines it anticipates in current and future clinical
trials; successfully scale its manufacturing process; obtain,
maintain or protect intellectual property rights related to its
product candidates; compete successfully with other companies that
are seeking to develop DMD/Duchenne treatments and gene therapies;
manage expenses; and raise the substantial additional capital
needed to achieve its business objectives. For a discussion of
other risks and uncertainties, and other important factors, any of
which could cause the Company’s actual results to differ from those
contained in the forward-looking statements, see the “Risk Factors”
section, as well as discussions of potential risks, uncertainties
and other important factors, in the Company’s most recent filings
with the Securities and Exchange Commission. In addition, the
forward-looking statements included in this Current Report on Form
8-K represent the Company’s views as of the date hereof and should
not be relied upon as representing the Company’s views as of any
date subsequent to the date hereof. The Company anticipates that
subsequent events and developments will cause the Company's views
to change. However, while the Company may elect to update these
forward-looking statements at some point in the future, the Company
specifically disclaims any obligation to do so.
Investor Contact: Carlo Tanzi, Ph.D. Kendall
Investor Relations 617-337-4680 investors@solidbio.com
Media Contact: Courtney Heath Scient Public
Relations 617-872-2462media@solidbio.com
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