NEW
YORK, July 10, 2024 /PRNewswire/ -- Spine
BioPharma, Inc., a company committed to developing non-opiate,
non-surgical therapies for the treatment of pain related
disabilities, today announced that it has signed an agreement with
Korean Company Ensol BioSciences, Inc. to expand the indications
(treatment scope) of its therapeutic drug treatment candidate,
SB-01 For Injection.
The agreement, valued at a total of $155
million, grants Spine BioPharma the exclusive rights to
develop and commercialize SB-01 For Injection, for all additional
indications beyond spine-related diseases, such as Osteoarthritis,
fibrotic diseases, and Oncological indications.
In 2018, Spine BioPharma acquired the right to develop and
commercialize SB-01 For Injection globally excluding Korea, from
South Korean pharmaceutical and chemical company, Yuhan Corporation
(who had originally licensed it from Ensol BioSciences). Spine
BioPharma is currently conducting its SB-01 Phase 3 MODEL Study
(Moderate – Severe Degenerative Disc Disease
Evaluation of the Lumbar Spine), the first
intradiscal pharmacologic treatment to enter Phase 3 studies for
the treatment of pain-related disability, associated with
Degenerative Disc Disease (DDD) and anticipates completing trial
enrollment of the 400-patient study in September 2024.
(Clinicaltrials.gov: NCT05516992).
Marc Viscogliosi, CEO of Spine
BioPharma, stated, "We are very pleased to have finalized this
agreement with Ensol BioSciences, and excited about the future
portfolio expansion opportunities it provides, beyond spine-related
diseases. This agreement, coupled with the anticipated conclusion
of the SB-01 Phase 3 MODEL Study enrollment, certainly broadens
Spine BioPharma's strategic framework considerations to address the
unmet needs of patients suffering from pain related disabilities,
and beyond".
About SB-01 For Injection
SB-01 is a 7-amino acid
synthetic peptide that binds to and antagonizes
TGF-Beta. TGF-Beta is a pleiotropic cytokine expressed by
almost every tissue and cell type, is stored in abundance in the
extracellular matrix, and possesses suppressive and stimulatory
signaling pathways. In many diseases, there are high
concentrations of TGF-Beta that result in a spectrum of negative
downstream effects including inflammation, fibrosis, hypertension,
neoinnervation, hyperexcitability of nerves and cell proliferation.
SB-01 modulates TGF-Beta concentration, without eliminating it,
mitigating the negative downstream effects. Considering this
mechanism of action, SB-01 has potential in the treatment of other
diseases beyond degenerative disc disease including osteoarthritis,
fibrotic diseases, and other significant unmet medical needs.
About Spine BioPharma
Spine BioPharma is committed to
developing non-surgical/non-opioid treatments that will reduce
pain, restore function, and slow or stop pathological disease
progression. Spine BioPharma's lead candidate, SB-01 For Injection,
is a first-in-class treatment of degenerative disc disease,
offering potential clinical benefits of pain relief, restoration of
function, and prevention of disease progression. To learn more
about Spine BioPharma,
visit www.spinebiopharma.com.
Contact:
Jason
Gallagher
Chief Commercial Officer & Chief Operating Officer
jgallagher@spinebiopharma.com
Office phone: (212)
583-9700
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SOURCE Spine Biopharma, Inc