Bone Therapeutics Reports Positive Efficacy Data for the ALLOB® Phase IIA Spinal Fusion Trial

BONE THERAPEUTICS (Euronext Brussels and Paris:BOTHE), the bone cell therapy company addressing high unmet medical needs in bone fracture repair, fracture prevention and spinal fusion, today reports positive efficacy data for the Phase IIA spinal fusion trial with ALLOB^®. Results of the first half of patients in the study show evidence of successful fusion and important clinical improvements in function, pain and general health as early as six months after treatment and all patients reached the primary and secondary endpoints at the end of the 12-month follow-up period.
Enrico Bastianelli, Chief Executive Officer of Bone Therapeutics,
commented: “Seeing evidence of fusion and the clinical
improvements in these patients as early as six months strengthens our
confidence in the potential of ALLOB^® to become
an important addition to the current standard of care. These results
give us great confidence for the remainder of the trial for which we
expect the full set of data in Q2 2017.”
Spinal fusion is the current standard of care for degenerative disc
disease to relieve pain and improve function. However, progression to
fusion with current treatments is slow, usually taking 18 to 24 months.
Furthermore, the surgery may result in lack of fusion and continuing
pain, leaving up to 30% of patients unsatisfied with their surgery.
Dynamic x-rays revealed absence of motion of the vertebral bodies (i.e.
fusion) in six out of eight patients at 6 months and in all patients at
9 and 12 months. Fusion was further evidenced by CT scans that show the
presence of bone bridges as from 6 months in 75% of assessable patients.
Back and leg pain improved dramatically, by over 50% and over 80%
respectively, as from 6 months throughout the follow-up period. In
addition, clinical evaluation demonstrated a 33% improvement in
functional disability score (using the Oswestry Disability Index) at six
months, which further increased to 40% at 12 months. General health
status improved 50% after 6 months and this level was likewise
maintained up to 12 months.
The Phase IIA trial in lumbar spinal fusion is designed to evaluate the
safety and efficacy of the addition of ALLOB^® to the standard
of care procedure for degenerative disc disease in which an interbody
cage with bioceramic granules is implanted to achieve fusion of the
lumbar vertebrae. Primary endpoints of the study are radiological
evaluation of fusion, improvement in pain and functional disability and
safety. The Company was able to demonstrate in preclinical
studies that the combination of bioceramics with ALLOB^®
cells significantly increased new bone formation and fusion in
comparison with bioceramics alone.
About ALLOB^®
ALLOB^® is a first-in-class allogeneic
differentiated osteoblastic (bone-forming) cell therapy product
developed for the treatment of orthopaedic conditions and bone diseases.
Allogeneic cell therapy involves the harvesting of cells from a healthy
donor, rather than from the treated patient. ALLOB^®
is currently being evaluated in three Phase I/IIA clinical trials for
delayed-union fractures, spinal fusion and the revision of failed spinal
fusions. ALLOB^® has been classified as a tissue
engineered product under the ATMP regulation 1394/2007EMA and received
orphan drug designation from the EMA (Europe) and FDA (US) for two
indications, osteonecrosis and osteogenesis imperfecta.
About spinal fusion
Spinal fusion is considered the gold standard surgery for treating a
broad spectrum of degenerative spine disorders, including degenerative
disc disease to relieve pain and improve function. Spinal fusion
consists of bridging two or more vertebrae with the use of a cage and
graft material, traditionally autologous bone graft, for fusing an
unstable portion of the spine or immobilizing a painful vertebral motion
segment. Despite the fact that spinal fusion surgery is routine,
non-union and failure to relieve lower back pain are unfortunately still
frequent as up to 25 to 30% of spinal fusion patients are not completely
satisfied with their surgery. Bone Therapeutics’ products are intended
to decrease the failure rate of spinal fusion surgeries.
About Bone Therapeutics
Bone Therapeutics is a leading biotechnology company specializing in
the development of cell therapy products intended for bone fracture
repair and fracture prevention. The current standard of care in this
field involves major surgeries and long recovery periods. To overcome
these problems, Bone Therapeutics is developing a range of innovative
regenerative products containing osteoblastic/bone-forming cells,
administrable via a minimally invasive percutaneous technique; a unique
proposition in the market.
PREOB^®, Bone Therapeutics’ autologous bone
cell product, is currently in pivotal Phase IIB/III clinical studies for
two indications: osteonecrosis and non-union fractures, and in Phase II
for severe osteoporosis. ALLOB^®, its allogeneic
“off-the-shelf” bone cell product, is in Phase II for the treatment of
delayed-union fractures and lumbar fusion for degenerative disease of
the spine, including a minimally invasive therapy for failed spinal
fusions. The Company also runs preclinical research programs and
develops novel product candidates.
Founded in 2006, Bone Therapeutics is headquartered in Gosselies
(South of Brussels, Belgium). Bone Therapeutics’ regenerative products
are manufactured to the highest GMP standards and are protected by a
rich IP estate covering 11 patent families. Further information is
available at: www.bonetherapeutics.com.
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